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Anesthesiology, V 127 • No 4 614 October 2017

B REASTFEEDING is an important public health con-cern, with documented maternal and infant health bene- fits.1,2 Neuraxial labor analgesia is used in the majority of births in the United States,3 but controversy exists as to whether neur- axial labor analgesia negatively impacts breastfeeding. A 2016 systematic review included 23 studies that investigated the association between neuraxial labor analgesia and breastfeeding outcomes.4 Results were conflicting; half of the studies found no association between neuraxial analgesia and breastfeeding outcomes, while the other half identified negative associations, and one found a positive association. Most studies were obser- vational trials; only three studies were randomized controlled trials. A possible explanation for these conflicting results is that many studies did not control for confounding variables known to influence breastfeeding success.4,5 Some studies were under- powered, analgesia management in both the neuraxial analge- sia and control groups differed or was not well described.

Opioids, such as fentanyl, are commonly used in combina- tion with local anesthetics in epidural solutions used for labor analgesia. Two prospective randomized studies examining the effect of epidural fentanyl on breastfeeding success reported

What We Already Know about This Topic

• There is controversy and disagreement between studies as to whether neuraxial analgesia for labor, particularly with fentanyl, affects postpartum breastfeeding

What This Article Tells Us That Is New

• A randomized parallel group study of three epidural solutions of bupivacaine with or without fentanyl showed that breastfeeding success at 6 weeks was not influenced by the epidural fentanyl concentration or the cumulative epidural fentanyl dose administered for labor analgesia

• Maternal and umbilical cord venous fentanyl and bupivacaine concentrations did not differ between women who discontinued breastfeeding (3 to 6%) and those who were still breastfeeding at 6 weeks postpartum

ABSTRACT

Background: Breastfeeding is an important public health concern. High cumulative doses of epidural fentanyl administered for labor analgesia have been reported to be associated with early termination of breastfeeding. We tested the hypothesis that breastfeeding success is adversely influenced by the cumulative epidural fentanyl dose administered for labor analgesia. Methods: The study was a randomized, double-blind, controlled trial of parous women at greater than 38 weeks gestation who planned to breastfeed, had successfully breastfed a prior infant, and who received neuraxial labor analgesia. Participants were randomized to receive one of three epidural maintenance solutions for labor analgesia (bupivacaine 1 mg/ml, bupiva- caine 0.8 mg/ml with fentanyl 1 μg/ml, or bupivacaine 0.625 mg/ml with fentanyl 2 μg/ml). The primary outcome was the proportion of women breastfeeding at 6 weeks postpartum. Maternal and umbilical venous blood fentanyl and bupivacaine concentration at delivery were measured. Results: A total of 345 women were randomized and 305 had complete data for analysis. The frequency of breastfeeding at 6 weeks was 97, 98, and 94% in the groups receiving epidural fentanyl 0, 1, and 2 μg/ml, respectively (P = 0.34). The cumula- tive fentanyl dose (difference: 37 μg [95% CI of the difference, −58 to 79 μg], P = 0.28) and maternal and umbilical cord venous fentanyl and bupivacaine concentrations did not differ between women who discontinued breastfeeding and those who were still breastfeeding at 6 weeks postpartum. Conclusions: Labor epidural solutions containing fentanyl concentrations as high as 2 μg/ml do not appear to influence breastfeeding rates at 6 weeks postpartum. (Anesthesiology 2017; 127:614-24)

This article is featured in “This Month in Anesthesiology,” page 1A. Corresponding article on page 593.

Submitted for publication April 7, 2017. Accepted for publication June 19, 2017. From the Department of Anesthesiology, Memorial Hermann Memorial City Medical Center, Houston, Texas (A.I.L.); Department of Anesthesiology (R.J.M., P.T., M.J.J.) and Center for Healthcare Studies (P.T.), Northwestern University Feinberg School of Medicine, Chicago, Illinois (R.J.M., P.T.); Department of Nursing, Northwestern Memorial Hospital Chicago, Illinois (N.W.); and Department of Anesthesia, University of Iowa Carver College of Medicine, Iowa City, Iowa (C.A.W.)

Epidural Labor Analgesia—Fentanyl Dose and Breastfeeding Success

A Randomized Clinical Trial

Amy I. Lee, M.D., Robert J. McCarthy, Pharm.D., Paloma Toledo, M.D., M.P.H., Mary Jane Jones, R.N., Nancy White, R.N., I.B.C.L.C., Cynthia A. Wong, M.D.

PERIOPERATIVE MEDICINE

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conflicting results. Beilin et al.6 reported that mothers who were randomized to receive a cumulative epidural fentanyl dose greater than or equal to 150 μg were more likely to stop nursing 6 weeks postpartum compared with mothers who received no fentanyl, or a cumulative epidural fentanyl dose less than150 μg. In contrast, Wilson et al., in a secondary analysis of a large randomized trial, concluded that neuraxial analgesia, irrespective of epidural fentanyl administration, did not hinder breastfeeding, even at 12 months postpartum.7

The purpose of the current study was to evaluate the impact of intrapartum epidural fentanyl on breastfeed- ing success in the initial postpartum period, as well as at 6 weeks and at 3 months postpartum. The primary outcome was self-reported breastfeeding at 6 weeks postpartum. In this superiority study, we tested the hypothesis that 6-week breastfeeding success is adversely influenced by the cumula- tive epidural fentanyl dose administered for labor analgesia. Secondary outcomes were 1-min Apgar scores less than 7, day-1 LATCH (Latch, Audible swallowing, Type of nipple, Comfort, and Hold/help) breastfeeding assessments, the rate of mothers who discontinued breastfeeding at 3 months, and the reasons stated for discontinuation of breastfeeding.8,9

Materials and Methods The study was approved by the Institutional Review Board of Northwestern University (Chicago, Illinois; STU00007275) and the protocol was registered at ClinicalTrials.gov (NCT01074190) on February 22, 2010. This manuscript adheres to the Consolidated Standards of Reporting Trials (CONSORT) guidelines. The study was a double-blind, ran- domized controlled trial conducted at Prentice Women’s Hospi- tal (Chicago, Illinois). Inclusion criteria were English-speaking parous women at greater than 38 weeks gestation who had suc- cessfully breastfed a prior infant for at least 6 weeks, expressed a desire to breastfeed for a least 3 months postpartum, and who planned to use neuraxial labor analgesia. Exclusion criteria included administration of a parenteral opioid prior to neur- axial labor analgesia, a history of chronic opioid therapy, or an expected delivery within 90 min of the request for analgesia.

A convenience sample of eligible women were screened and approached shortly after admission to the labor and delivery unit. Screening included an assessment of the wom- an’s prior breastfeeding history, and plans for labor analgesia use and breastfeeding with the current newborn. Women meeting inclusion criteria provided informed written con- sent for study participation. Recorded baseline maternal characteristics recorded included age, height, weight, gra- vidity/parity, and gestational age, and an assessment of the participants’ motivation for breastfeeding using the Breast- feeding Motivational Measurement Scale.10,11

Participants were randomly allocated to one of three study groups defined by the solution used to maintain epi- dural analgesia: bupivacaine 1 mg/ml + fentanyl 0 μg/ml, bupivacaine 0.8 mg/ml + fentanyl 1 μg/ml, and bupiva- caine 0.625 mg/ml + fentanyl 2 μg/ml. Prior to the study

commencement, three-group block randomization (1:1:1) using randomly selected block sizes of 3, 6, and 9 was performed by an investigator (R.J.M.) using a computer- generated allocation list.12 Group allocations were con- cealed in sequentially numbered opaque envelopes, which were opened by the research nurse at the time of request for neuraxial analgesia. Epidural solutions were prepared by pharmacy personnel not involved in the study. The research nurse obtained the epidural solution and concealed the con- tents by marking it as study drug. The research nurse was not blinded to group allocation. All other study personnel, including the anesthesiologist, lactation consultants, and research nurses performing follow-up assessments, and the study participants, were blinded to group allocation.

Labor analgesia was initiated using a combined spinal- epiduraltechnique with an intrathecal injection of bupiva- caine 2.5 mg and fentanyl 15 µg, and an epidural test dose of 1.5% lidocaine with epinephrine 5 µg/ml (3 ml). An epidural catheter was sited and analgesia was maintained using patient-controlled epidural analgesia (PCEA). The nonblinded research nurse set up the PCEA pump. The ini- tial settings for PCEA were a basal infusion rate of 8 ml/h, patient-administered epidural boluses of 8 ml with a lock-out interval of 10 min and a 1-h infusion limit of 32 ml. Break- through pain was managed by the anesthesia provider using manually administered boluses of bupivacaine 1.25 mg/ml without fentanyl.

Cervical dilation at the request for analgesia was recorded. Fifteen minutes following the intrathecal injec- tion a verbal rating pain score (0 to 100-point scale), upper sensory analgesia level to ice and degree of motor blockade using the 4-point Bromage scale (none, partial, almost com- plete, complete) were assessed.13 Motor block was assessed again at 2 h following intrathecal injection and at deliv- ery. Samples of maternal venous blood and umbilical cord venous blood were collected from a double-clamped section of the umbilical cord into 3.0-ml spray-coated lithium hep- arin and polymer-separator gel tubes at delivery. Cells were removed by centrifugation and samples stored at −20°C until analysis.

Participants were queried shortly after delivery regarding satisfaction with labor analgesia using a 0 to 100-point scale. The mode of delivery, duration of the epidural infusion, total epidural infusate volume and manual bupivacaine bolus doses (for treatment of breakthrough pain) were recorded. Infant data included birth weight, umbilical cord blood gas values, 1-min Apgar score (assessed by labor nurses or neo- natology team), and neonatal intensive care unit admission.

Breastfeeding was assessed by one of three lactation consultants, certified by the International Board of Lacta- tion Consultant Examiners (Fairfax, Virginia), on the first postpartum day using the LATCH assessment tool, a vali- dated tool routinely used at Prentice Women’s Hospital.8,9 Consultants observed mothers breastfeeding during the visit. Research nurses visited mothers prior to discharge and

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queried them regarding the estimated percent contact time of maternal-to-infant skin during the first 24 h following delivery. At 6 weeks and at 3 months postpartum, follow- up phone calls were made by a blinded research nurse to assess the duration of breastfeeding. Mothers who reported discontinuation of breastfeeding were asked an open-ended question about the reason for discontinuation.

Plasma concentrations of fentanyl and bupivacaine were measured using high-performance liquid chromatography. Fentanyl and bupivacaine concentrations were determined by liquid chromatography-tandem mass spectrometry after sample preparation by solid-phase extraction using an API 3000 liquid chromatography-tandem mass spectrometry sys- tem (Applied Biosystems, Foster City, California) equipped with an Agilent 1100 series high-performance liquid chro- matography system (Agilent Technologies, Wilmington, Delaware) as previously described.14 The internal standard was alfentanil for fentanyl and mepivacaine for bupivacaine analysis. The plasma fentanyl standard curve was linear from 0.01 to 2.5 ng/ml with coefficients of variation of 15% or less throughout the entire concentration range. The linear range for the plasma bupivacaine standard curve was 1.0 to 100.0 ng/ml, with coefficients of variation of 15% or less throughout the entire concentration range.

Statistical Analysis The primary outcome was the rate of breastfeeding at 6 weeks postpartum. The number of mothers who breastfed through- out the 6-week period in each group were compared using a chi-square statistic. A sensitivity analysis was performed assuming that participants lost to follow-up had discontin- ued breastfeeding. Differences and CI for the difference in the rate of breastfeeding among groups were calculated using the Pearson-Klopper method. Secondary outcomes were 1-min Apgar scores less than 7, day-1 LATCH breastfeeding assessments, the rate of mothers who discontinued breast- feeding at 3 months, and the reasons stated for discontinua- tion of breastfeeding.

Maternal characteristics, breastfeeding history and plan and motivational assessment in the current pregnancy, labor analgesia and infant outcomes, and breastfeeding during the hospital stay were compared among study groups. Continu- ous and interval data were compared among groups using the Kruskal-Wallis H test. Post hoc comparisons were made using Dunn’s test with Bonferroni correction for 6 compari- sons (P < 0.008). Nominal data were compared using a chi- squared test. All statistical tests were two-tailed and a P value less than 0.05 was required to reject the null hypothesis.

Because the independent variable of interest, cumulative epidural fentanyl dose, was dependent on both the epidural solution fentanyl concentration and the duration of labor analgesia, the cumulative fentanyl dose, and the maternal and umbilical cord venous plasma fentanyl concentrations were compared among groups and between women who did and did not continue breastfeeding at 6 weeks using the

Mann-Whitney U test. Differences in medians and CI of median differences were calculated using a 10,000-sample bootstrap.

Maternal characteristics, breastfeeding history and plan and motivational assessment in the current pregnancy, labor analgesia and infant outcomes, and LATCH breastfeeding assessments during the hospital stay also were compared between women who did and did not continue breastfeeding at 6 weeks using the Mann-Whitney U test or a chi-square test. Risk factors identified on univariable analysis to be asso- ciated with discontinuation of breastfeeding at 6 weeks post- partum (P < 0.2) were entered into a multivariable logistic regression model to adjust estimates of risk for main effects. Prior to multivariable modeling, multicollinearity was assessed by evaluating the tolerance, variance inflation factor, and the condition index of the variables for inclusion. Toler- ance greater than 0.1, a variance inflation factor less than 10 or a condition index less than 30 were considered accept- able to enter the variable into the logistic regression model. Measures of effect in the multivariable model are reported as an adjusted odds ratio and 95% confidence limits. The accuracy of the logistic regression model was evaluated by the area under the receiver operator characteristics curve and 95% CI.

Based on the study by Beilin et al.,6 the incidence of failed breastfeeding at 6 weeks was estimated to be 2, 6, and 19% in study groups in the current study. Using a chi-square test with 2 degrees of freedom, significance level of 0.05, and beta of 0.2, a sample of 183 participants was necessary to demonstrate an effect size (Cramér’s ω) of 0.23 using a supe- riority study design. Beilin et al. also reported that the rate of ineffective sucking during the immediate postpartum period was 3, 7, and 12%, respectively.6 Using these estimates, the effect size is 0.14; a total sample size of 492 would be needed to achieve 80% power to detect a difference in sucking among groups. However, using the LATCH assessment tool, we anticipated greater sensitivity in detecting early postpar- tum differences in infant sucking and estimated an effect size (Cramér’s ω) of 0.175.9 Using these assumptions, a total sample size of 315 achieved 80% power to detect a difference among groups using a chi-square test with 2 degrees of free- dom and a significance level of 0.05. We elected to recruit an additional 10 participants per study group to account for loss to follow-up, thus the planned total sample size was 345.

Statistical analysis was performed using RStudio version 1.0.136, release date December 21, 2016 (Integrated Devel- opment for R; RStudio, Inc., USA) and R version 3.3.3, release date March 6, 2017 (The R Foundation for Statisti- cal Computing, Austria). Sample size analysis was performed using PASS 2005 (NCSS, LLC, USA).

Results Between February 2010 and January 2015, 956 women were assessed for eligibility, and 345 were enrolled in the study. Twenty-six participants were lost to follow-up prior

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to the 3-month follow-up assessment. The flow of study par- ticipants is shown in figure 1. Maternal characteristics are shown in table 1. The maternal breastfeeding history, plan to breastfeed following the current pregnancy, and breastfeed- ing motivational assessment did not differ among any pair of epidural infusion groups.

There was no difference in the breastfeeding rate at the 6-week and the 3-month follow-up period among the groups (table 2). The frequency of breastfeeding at 6 weeks was 97, 98, and 94% in the bupivacaine 1 mg/ml + fentanyl 0 μg/ml, bupivacaine 0.8 mg/ml + fentanyl 1 μg/ml and bupivacaine 0.625 mg/ml + fentanyl 2 μg/ml groups, respectively (P = 0.34). Sensitivity analysis assum- ing that participants lost to follow-up had discontinued

breastfeeding at 6 weeks did not change the results (P = 0.97). The stated reason for breastfeeding discontinuation did not differ among groups (P = 0.72). Most women dis- continued breastfeeding prior to 3 months for maternal rather than infant reasons.

Labor analgesia outcomes are described in table 3. More women in the bupivacaine 1 mg/ml + fentanyl 0 μg/ml group had motor block at the time of delivery than the bupivacaine 0.625 mg/ml + fentanyl 2 μg/ml group (difference 14% [99.2% CI, 2 to 26%], P < 0.001). The cumulative fentanyl and bupivacaine doses, and maternal plasma concentrations at the time of delivery, varied among groups. The verbal rating score for analgesia satisfaction did not differ among groups and there was no difference in the mode of delivery.

Fig. 1. Consolidated Standards of Reporting Trials (CONSORT) flow diagram.

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Infant weight, umbilical cord blood gas values (data not shown), the incidence of 1-min Apgar scores less than 7, and neo- natal intensive care unit admissions did not differ among study groups (table 3). Umbilical cord venous fentanyl and bupivacaine

concentrations varied among groups. LATCH scores, the num- ber of women observed breastfeeding by the lactation consultant, and the estimated percent of infant-to-maternal skin contact time in the first 24 h following delivery were similar among groups.

Table 1. Maternal Characteristics, Breastfeeding History and Plan, and Motivational Assessment

Patient-controlled Epidural Analgesia Solution*

P Value

Bupivacaine 1 mg/ml + fentanyl 0 μg/ml

(n = 111)

Bupivacaine 0.8 mg/ml + fentanyl 1 μg/ml

(n = 109)

Bupivacaine 0.625 mg/ml + 2 μg/ml fentanyl

(n = 112)

Age (yr) 33 (31 to 37) 34 (32 to 36) 34 (31 to 36) 0.94 Body mass index (kg/m2) 28 (26 to 31) 28 (26 to 31) 29 (26 to 31) 0.81 Gravidity 3 (2 to 3) 3 (2 to 3) 2 (2 to 3) 0.08 Parity 1 (1 to 2) 1 (1 to 2) 1 (1 to 2) 0.32 Gestational age (d) 277 (273 to 280) 276 (274 to 281) 276 (273 to 279) 0.88 Assessment of breastfeeding history with prior child 0.37 6 months 82 (74) 72 (66) 73 (65) Reason for discontinuing, n (%) 0.50 Return to work 35 (31) 30 (28) 36 (32) Perceived time to stop 22 (20) 22 (20) 20 (18) Lack of time 3 (3) 2 (2) 9 (8) Pregnancy 10 (9) 9 (8) 9 (8) Inadequate milk production 11 (10) 19 (17) 14 (12) Child eating solid foods/teething 21 (19) 17 (16) 19 (17) Difficulty with breastfeeding 9 (8) 10 (9) 5 (5) Support for breastfeeding, n (%) 0.25 Weak 0 2 (2) 1 (1) Moderate 9 (8) 13 (12) 18 (16) Strong 101 (92) 94 (86) 93 (83) Used an assistive device/nipple shield, n (%) 19 (17) 22 (20) 18 (16) 0.71 Skin-to-skin contact in first 24 h*, n (%) 0.25 Did not remember 2 (2) 3 (4) 2 (2) 0 to 25% 35 (31) 33 (30) 43 (28) 25 to 50% 28 (34) 41 (37) 39 (35) 50 to 75% 23 (21) 27 (25) 25 (22) 75 to 100% 13 (12) 5 (5) 3 (3) Time from delivery to initial breastfeeding, n (%) 0.53 Did not remember 4 (4) 2 (2) 5 (5) 0 to 1 h 90 (81) 80 (73) 79 (70) 1 h to 3 h 9 (7) 19 (17) 16 (14) 4 h to 10 h 4 (4) 4 (4) 5 (5) > 10 h 4 (4) 4 (4) 7 (6) Took a breastfeeding class or received

breastfeeding education, n (%) 62 (56) 52 (48) 62 (55) 0.40

Planned breastfeeding with current pregnancy and breastfeeding motivational assessment Planned duration of breastfeeding, n (%) 0.03 6 months 63 (57) 76 (70) 60 (54) Breastfeeding motivational measurement scale Interest/enjoyment (maximum 30) 24 (20 to 27) 24 (20 to 27) 24 (20 to 26) 0.60 Perceived competence (maximum 30) 23 (20 to 26) 22 (19 to 25) 22 (20 to 25) 0.07 Effort/importance (maximum 25) 23 (20 to 25) 23 (20 to 25) 23 (20 to 25) 0.46 Pressure/tension (maximum 25) 22 (19 to 25) 20 (18 to 23) 21 (18 to 24) 0.02 Value/usefulness (maximum 30) 30 (30 to 30) 30 (30 to 30) 30 (29 to 30) 0.93 Total score (maximum 140) 119 (111 to 127) 117 (109 to 124) 117 (110 to 124) 0.28

Data reported as median (interquartile range) or n (%) of group. *Estimated by mother.

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Cumulative fentanyl dose, maternal and umbilical cord venous fentanyl and bupivacaine concentrations did not differ in participants who discontinued breastfeeding com- pared with those who were still breastfeeding at 6 weeks and 3 months (table 4). Planned duration of breastfeed- ing, the use of a device/nipple shield with prior breastfeed- ing, the LATCH score assessed by the lactation nurse, and the 15-min verbal rating pain score were associated with discontinuation of breastfeeding within 6 weeks of deliv- ery (P < 0.2) in the univariable analysis. The only variable associated with continued breastfeeding at 6 weeks was planned duration of breastfeeding (table 5). The area under the receiver operating characteristics curve for the logistic regression model was 0.82 (95% CI, 0.69 to 0.95). The adjusted odds ratio for discontinuation of breastfeeding less than 6 weeks per 25 μg in cumulative epidural fentanyl received was 1.05 (95% CI, 0.89 to 1.24, P = 0.57).

Discussion The important finding of this study was the lack of asso- ciation between the cumulative epidural fentanyl dose and discontinuation of breastfeeding within 3 months postpar- tum in motivated women who had successfully breastfed in a prior pregnancy. Overall, 93% of the women who com- pleted study follow-up were still breastfeeding at 3 months postpartum; maternal factors were cited for discontinuation by 77% of women who had stopped breastfeeding. These findings suggest that epidural solutions containing fentanyl in concentrations as high as 2 μg/ml do not interfere with subsequent breastfeeding.

Worldwide, health organizations have been crusading to increase breastfeeding rates because of the myriad of asso- ciated health benefits.1,15 Children who are breastfed have improved immunity and mothers who breastfeed have a lower incidence of breast and ovarian cancers and diabe- tes.1,15 According to a U.S. Centers for Disease Control National Immunization Survey, 80% of mothers started breastfeeding after birth and 51% were still breastfeeding at 6 months in 2012 compared with 71 and 38%, respectively, in 2002.16 The rate of women who use neuraxial labor anal- gesia is increasing.3,17 As medical practitioners, it is impor- tant to ensure our anesthetic interventions do not impede the mother’s or infant’s ability to breastfeed.

The results of previous studies are inconsistent, but most of the data are from observational trials. A 2016 system- atic review identified only three randomized controlled tri- als. Beilin et al.6 randomized women to three groups with cumulative doses of epidural fentanyl of 0, 1 to 150 μg, and greater than 150 μg. The primary outcome was “breastfeed- ing difficulty” (none, mild, moderate, severe) as assessed by the mother on postpartum day one. There was a trend toward increased difficulty in the high-dose fentanyl group, but the difference was not significant. The lactation consul- tants identified no differences in breastfeeding difficulty on postpartum day one among groups. At 6 weeks postpartum, more women in the high-dose fentanyl group had discon- tinued breastfeeding than those in the low-, or no-fentanyl groups (17, 5, and 2%, respectively). Wilson et al.7 per- formed a secondary analysis of a randomized controlled trial in three groups of women randomized to receive different neuraxial analgesic techniques. The control group received

Table 2. Infant and Breastfeeding Outcomes at Follow-up Assessments

Patient-controlled Epidural Analgesia Solution

P Value

Bupivacaine 1 mg/ml + fentanyl 0 μg/ml

(n = 111)

Bupivacaine 0.8 mg/ml + fentanyl 1 μg/ml

(n = 109)

Bupivacaine 0.625 mg/ml + 2 μg/ml fentanyl

(n = 112)

6-week follow-up Delivery follow-up interval (d) 42 (41 to 44) 42 (41 to 45) 42 (41 to 47) 0.06 Breastfeeding* 0.34† Yes 100 (97) 99 (98) 102 (94) No 3 (3) 2 (2) 6 (6) Lost to follow-up 8 8 4 3-month follow-up Delivery follow-up interval (d) 91 (89 to 93) 91 (90 to 95) 91 (90 to 95) 0.76 Breastfeeding* 0.10† Yes 94 (94) 96 (96) 93 (88) No 6 (6) 4 (4) 12 (12) Lost to follow-up 11 9 7 Reason stated for discontinuation 0.72 Maternal† 4 (67) 3 (75) 10 (83) Infant‡ 2 (33) 1 (25) 2 (17)

Data presented as median (interquartile range) or n (%) of group. *Rate of breastfeeding and P value for comparison based on participants with complete follow-up. †Maternal reasons: return to work (n = 7), breast pain/ mastitis (n = 4), perceived low supply (n = 4), overactive letdown (n = 1), maternal cerebral vascular accident (n = 1). ‡Infant reasons: infant did not latch well (n = 2), infant did not tolerate milk/colicky (n = 2), newborn had infection and physician instructed mother to stop (n = 1).

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Table 3. Labor Analgesia Outcomes, Mode of Delivery, Maternal and Umbilical Cord Fentanyl and Bupivacaine Levels, Infant and Breastfeeding Outcomes during Hospital Stay

Patient-controlled Epidural Analgesia Solution

P Value

Bupivacaine 1 mg/ml + fentanyl 0 μg/ml

(n = 111)

Bupivacaine 0.8 mg/ml + fentanyl 1 μg/ml

(n = 109)

Bupivacaine 0.625 mg/ ml + 2 μg/ml fentanyl

(n = 112)

Cervical dilation at labor analgesia request (cm) 3 (3 to 4) 3 (2 to 4) 3 (2.5 to 4) 0.14 VRPS (0 to 100) 15 min following intrathecal drug

administration 2 (0 to 6) 3 (1 to 9) 3 (0 to 9) 0.15

Upper level of sensory analgesia to ice 15 min following intrathecal drug administration

Left T6 (T8 to T5) T6 (T7 to T5) T6 (T7 to T5) 0.84 Right T6 (T8 to T5) T6 (T7 to T5) T6 (T7 to T5) 0.97 Motor block assessment* n (%) 15 min following intrathecal injection 0.61 None 106 (95) 105 (97) 110 (98) Partial 4 (4) 3 (3) 2 (2) Almost complete 1 (1) 0 0 Complete 0 0 0 2 h following intrathecal injection 0.70 None 106 (95) 105 (96) 108 (96) Partial 4 (4) 4 (4) 4 (4) Almost complete 1 (1) 0 0 Complete 0 0 0 At delivery 0.03 None 92 (82) 100 (91) 108 (96) Partial 14 (13) 5 (5) 4 (4) Almost complete 4 (4) 4 (4) 0 Complete 1 (1) 0 0 Duration of epidural infusion (min) 207 (149 to 298) 216 (165 to 327) 197 (133 to 319) 0.37 Total epidural infusion volume (ml) 56 (40 to 85) 63 (46 to 94) 62 (41 to 98) 0.49 Manual bupivacaine boluses for breakthrough

pain, n (%) 14 (13) 21 (19) 24 (21) 0.20

Cumulative fentanyl dose (μg) 15 (15 to 15) 78 (60 to 109) 139 (97 to 210) < 0.001 Cumulative bupivacaine dose (mg) 58 (40 to 86) 55 (37 to 81) 42 (25 to 61) < 0.001 Plasma bupivacaine concentration (ng/ml) 228 (159 to 306) 173 (118 to 257) 144 (108 to 230) < 0.001 Plasma fentanyl concentration (ng/ml) 0.01 (0.007 to 0.02) 0.07 (0.05 to 0.09) 0.13 (0.09 to 0.18) < 0.001 Verbal rating score for analgesia satisfaction

(0 to 100) 91 (76 to 97) 91 (76 to 99) 86 (74 to 96) 0.38

Mode of delivery, n (%) Vaginal 111 (100) 107 (98) 110 (98) Assisted vaginal 0 1 (1) 2 (2) 0.73 Cesarean 0 1 (1) 0 Infant weight (kg) 3.54 (3.32 to 3.77) 3.61 (3.28 to 3.91) 3.57 (3.31 to 3.87) 0.39 Umbilical vein plasma bupivacaine concentration

(ng/ml) 63 (48 to 82) 50 (31 to 72) 44 (27 to 67) < 0.001

Umbilical vein plasma fentanyl concentration (ng/ml)

0.005 (0.005 to 0.10) 0.03 (0.02 to 0.04) 0.06 (0.04 to 0.09) < 0.001

Apgar score < 7 at 1 min, n (%) 1 (4) 2 (4) 0 (0) 0.36 Neonatal intensive care unit admission, n (%) 1 (1) 2 (2) 2 (2) 0.81 Breastfeeding at lactation consultant assessment,

n (%) 0.12

Yes 98 (88) 96 (88) 98 (87) No 8 (7) 9 (8) 3 (3) Consultant not available 5 (5) 4 (4) 11 (10)

(Continued)

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epidural bupivacaine without fentanyl. The second and third groups received epidural and combined spinal-epidural analgesia, respectively, both initiated with bupivacaine and fentanyl and maintained with epidural bupivacaine/fen- tanyl.7 The mean cumulative fentanyl doses in the epidural and combined spinal-epidural groups were 163 μg and 107 μg, respectively. A matched comparison group that received no analgesia or systemic opioid analgesia (i.e., meperidine) also was recruited. The control group that received meperi- dine analgesia had a lower breastfeeding initiation rate than women who received neuraxial analgesia or no analgesia. A mail questionnaire sent one year after delivery assessed breastfeeding outcomes (overall number of responders was 1,043). The overall mean duration of breastfeeding was 15 weeks, and there were no differences among the neuraxial study groups and the matched control group and no differ- ence in the proportion of women still breastfeeding at one year. In a randomized controlled trial reported in Chinese with an English abstract, no differences in time of initiation of lactation were found between women randomized to ropi- vacaine epidural analgesia (no opioid) and a control group without analgesia.18

The addition of opioids to local anesthetics for the maintenance of epidural analgesia has several advantages. Neuraxial local anesthetics and opioids work synergistically to provide analgesia.19 The combination of the two types of drugs allows the use of lower doses of both drugs, thus decreasing the rate and severity of adverse effects of both drugs. One of the adverse effects of neuraxial local anesthet- ics is motor block. The density of motor blockade is directly associated with the neuraxial local anesthetic dose. Motor block is uncomfortable for parturients because it restricts mobility. Furthermore, a 2013 meta-analysis of studies

comparing low- to high-concentration local anesthetic solu- tions for maintenance of labor analgesia found that high compared to low-concentration techniques are associated with an increased risk of instrumental vaginal delivery.20 The finding that neuraxial opioids do not adversely affect breast- feeding is important, because removal of opioids from the epidural solution would require an increase in local anes- thetic concentration and its associated adverse effects.

There are several limitations to our study design and con- clusions. In the current study, the number of women exposed to a cumulative epidural fentanyl dose greater than 150 μg was low (19%). The median fentanyl dose administered in the high-dose fentanyl group in the study by Beilin et al. was 200 μg compared to 139 μg in the current study.6 This differ- ence is, in part, due to the inclusion of fentanyl in the epidural initiation bolus dose and in the bolus doses administered for breakthrough pain in the Beilin et al. study.6 Additionally, the median duration of labor analgesia was longer in their study. In our study, the rate of continued breastfeeding at 6 weeks in women who received less than 150 μg of fentanyl was 96.4% (95% CI, 93.5 to 95.5%) compared with 96.7% (95% CI, 88.6 to 99.1%) in women who received greater than or equal to 150 μg. Therefore, we cannot rule out noninferiority of cumulative epidural fentanyl greater than or equal to 150 μg at a margin of noninferiority of 5%. In addition, we found a rate of discontinuation of breastfeeding of 10.2% in women exposed to a cumulative fentanyl dose greater than or equal to 150 μg prior to 3 months compared with 6.5% of those who received less than 150 μg (difference 3.7% [95% CI of the difference, −4 to 12%], P = 0.31). At the level of differ- ence observed at 3 months, a sample size of 1,542 partici- pants (771 per group) would be required to have 80% power to detect this difference at an alpha of 0.05, if it were real.

LATCH score (0 to 2 for each factor) Latch 2 (2 to 2) 2 (2 to 2) 2 (2 to 2) 0.59 Audible swallowing 2 (1 to 2) 2 (1 to 2) 2 (1 to 20 0.38 Type of nipple 2 (2 to 2) 2 (92 to 20) 2 (2 to 2) 0.63 Comfort (breast/nipple) 2 (1 to 2) 2 (1 to 20) 2 (1 to 2) 0.88 Hold (positioning) 1 (1 to 2) 1 (1 to 2) 1 (1 to 2) 0.63 Total score (maximum 10) 8.5 (8 to 9) 8 (8 to 9) 9 (8 to 9) 0.35 Skin-to-skin contact during first 24 h†, n (%) 0.12 0 to 25% 72 (68) 70 (69) 71 (70) 25 to 50% 19 (18) 28 (26) 17 (17) 50 to 75% 9 (9) 8 (7) 11 (11) 75 to 100% 5 (5) 0 (0) 2 (2)

Data presented as median (interquartile range) or n (%) of group. *Motor block definitions: None = full leg movement, full flexion of knees and ankles; Partial = inability to raise extended legs, just able to flex knees, full ankle flexion; Almost complete = inability to flex knees, some flexion of ankles possible; Complete = no movement possible (unable to move legs or feet). †Estimated by mother. LATCH = Latch, Audible swallowing, Type of nipple, Comfort, and Hold/help; VRPS = verbal rating pain score.

Table 3. (Continued)

Patient-controlled Epidural Analgesia Solution

P Value

Bupivacaine 1 mg/ml + fentanyl 0 μg/ml

(n = 111)

Bupivacaine 0.8 mg/ml + fentanyl 1 μg/ml

(n = 109)

Bupivacaine 0.625 mg/ml + 2 μg/ml fentanyl

(n = 112)

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Neuraxial Fentanyl and Breastfeeding

Therefore, although the results of the current study cannot entirely rule out an association between high-dose epidural fentanyl and breastfeeding success, our data suggest that if an association exists, the effect is small in motivated women when epidural infusions contain fentanyl 2 μg/ml or less and epidural fentanyl is not administered for breakthrough pain.

A further limitation of the current study is that we did not study nulliparous women. Several factors are known to influ- ence breastfeeding success, including institutional breastfeeding support and the mother’s social support system.5 We elected to study parous women who had previously successfully breastfed to minimize variability in other factors known to influence this outcome. Beilin et al. also studied this population, allowing our results to be directly compared.6 Additionally, we anticipated that it would be more difficult to enroll nulliparous women in a randomized controlled trial. Although we cannot conclude that epidural fentanyl does not affect breastfeeding success in first-time mothers, from a pharmacokinetic and -dynamic standpoint, it is unlikely given the results of the current study. Our study was a single-center study in an urban population and results may differ in other environments with less support of breastfeeding. The overall rate of exclusive breastfeeding at discharge at Prentice Women’s Hospital in 2014 was 59%.21 During the time period of the study, the hospital was pursu- ing Baby Friendly status.22 A final limitation is that both the fentanyl and bupivacaine concentrations changed in the three epidural study solutions. We intentionally designed the study to administer equieffective analgesic concentrations of epidural solution to women in the three study groups; thus, the lower- concentration fentanyl solution contained a higher concentra- tion of bupivacaine. There is no credible evidence that epidural local anesthetic influences neonatal outcomes, but lactation outcomes have not been studied. It is possible that we observed minimal differences between groups because both fentanyl and bupivacaine negatively influence lactation.

In conclusion, among motivated parous women with a previous history of successful breastfeeding, epidural analge- sia maintained with an analgesia solution that contains fen- tanyl did not have adverse effects on breastfeeding outcomes.

Acknowledgments The authors acknowledge the contributions of Michael J. Avram, Ph.D., Northwestern University Feinberg School of Medicine, Chicago, Illinois (contribution analysis of bu- pivacaine and fentanyl concentrations); Deborah Flores, R.N., I.B.C.L.C., and Donna Stanton, R.N., I.B.C.L.C., North- western Memorial Hospital, Chicago, Illinois (contribution breastfeeding assessments); Rene Gora, R.N., and Yvonne Jekels, R.N., Northwestern Memorial Hospital, Chicago, Il- linois (contribution subject recruitment and follow-up).

Research Support This study was supported in part by the Evergreen Invita- tional Grant of the Northwestern Memorial Foundation and Department of Anesthesiology at Northwestern University Feinberg School of Medicine (Chicago, Illinois). The funding Ta

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Anesthesiology 2017; 127:614-24 623 Lee et al.

PERIOPERATIVE MEDICINE

organization had no role in design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Competing Interests The authors declare no competing interests.

Correspondence Address correspondence to Dr. McCarthy: Department of Anesthesiology, Northwestern University, Feinberg School of Medicine, 251 E. Huron St., Feinberg 5–704, Chicago, Illinois 60611. r-mccarthy@northwestern.edu. This article may be ac- cessed for personal use at no charge through the Journal Web site, www.anesthesiology.org.

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2. American Public Health Association: American Public Health Association Policy Statement 00714. A call to action on breast- feeding: A fundamental public health issue, 2007. Available at: https://www.apha.org/policies-and-advocacy/public-health- policy-statements/policy-database/2014/07/29/13/23/a-call- to-action-on-breastfeeding-a-fundamental-public-health-issue. Accessed April 6, 2017

3. Osterman MJ, Martin JA: Epidural and spinal anesthesia use during labor: 27-state reporting area, 2008. Natl Vital Stat Rep 2011; 59:1–13, 16

4. French CA, Cong X, Chung KS: Labor Epidural Analgesia and Breastfeeding: A Systematic Review. J Hum Lact 2016; 32:507–20

5. Szabo AL: Review article: Intrapartum neuraxial analgesia and breastfeeding outcomes: limitations of current knowl- edge. Anesth Analg 2013; 116:399–405

6. Beilin Y, Bodian CA, Weiser J, Hossain S, Arnold I, Feierman DE, Martin G, Holzman I: Effect of labor epidural analgesia with and without fentanyl on infant breast-feeding: A pro- spective, randomized, double-blind study. ANESTHESIOLOGY 2005; 103:1211–7

7. Wilson MJ, MacArthur C, Cooper GM, Bick D, Moore PA, Shennan A; COMET Study Group UK: Epidural analgesia and breastfeeding: A randomised controlled trial of epidural techniques with and without fentanyl and a non-epidural comparison group. Anaesthesia 2010; 65:145–53

8. Jensen D, Wallace S, Kelsay P: LATCH: A breastfeeding charting system and documentation tool. J Obstet Gynecol Neonatal Nurs 1994; 23:27–32

9. Kumar SP, Mooney R, Wieser LJ, Havstad S: The LATCH scor- ing system and prediction of breastfeeding duration. J Hum Lact 2006; 22:391–7

10. Stockdale J, Sinclair M, Kernohan G, McCrum-Gardner E, Keller J: Sensitivity of the breastfeeding motivational mea- surement scale: A known group analysis of first time moth- ers. PLoS One 2013; 8:e82976

11. Stockdale J, Sinclair M, Kernohan WG, Dunwoody L, Cunningham JB, Lawther L, Wier P: Assessing the impact of midwives’ instruction: The breastfeeding motivational instructional measurement scale. Evidence Based Midwifery 2008; 6:27–34

12. Harrell F. Block randomization with random block sizes. 2008. Available at: http://biostat.mc.vanderbilt.edu/wiki/ Main/BlockRandomizationWithRandomBlockSizes. Accessed April 6, 2017

13. Bromage P: Epidural Anesthesia. Philadelphia, W.B. Saunders, 1978

14. Nitsun M, Szokol JW, Saleh HJ, Murphy GS, Vender JS, Luong L, Raikoff K, Avram MJ: Pharmacokinetics of midazolam, propofol, and fentanyl transfer to human breast milk. Clin Pharmacol Ther 2006; 79:549–57

15. Office on Women’s Health at the U.S. Department of Health and Human Services: Breastfeeding 2014. Available at: http:// www.womenshealth.gov/breastfeeding/breastfeeding-bene- fits.html. Accessed April 6, 2017

16. U.S. Centers for Disease Control and Prevention: Breastfeeding among U.S. children born 2002–2012, CDC National Immunization Survey, 2016. Available at: https://www.cdc. gov/breastfeeding/data/NIS_data/. Accessed April 6, 2017

17. Traynor AJ, Aragon M, Ghosh D, Choi RS, Dingmann C, Vu Tran Z, Bucklin BA: Obstetric Anesthesia Workforce Survey: A 30-Year Update. Anesth Analg 2016; 122:1939–46

18. Chen YM, Li Z, Wang AJ, Wang JM: Effect of labor analgesia with ropivacaine on the lactation of paturients [in Chinese]. Zhonghua Fu Chan Ke Za Zhi 2008; 43:502–5

19. Ngan Kee WD, Khaw KS, Ng FF, Ng KK, So R, Lee A: Synergistic interaction between fentanyl and bupivacaine

Table 5. Multivariable Analysis of Total Fentanyl Expose Adjusted for Potential Confounders (P ≤ 0.2) on Likelihood of Discontinuation of Breastfeeding within 6 Weeks

Breastfeeding

(n = 301) Not Breastfeeding

(n = 11) P

Value* β Odds Ratio

95% CI of Odds Ratio

P Value†

Cumulative epidural fentanyl dose (μg) 72 (15 to 119) 109 (15 to 149) 0.28 0.05 1.05‡ 0.89 to 1.24 0.57 LATCH score (max 10) 9 (8 to 9) 8 (7 to 9) 0.08 −0.35 0.70 0.45 to 1.09 0.11 Used an assistive device/nipple shield 50 (16) 5 (45) 0.03 0.88 2.40 0.59 to 9.84 0.22 VRPS (0 to 100) 15 min following

intrathecal injection 3 (1 to 8) 4 (1 to 11) 0.12 0.05 1.05 0.99 to 1.11 0.10

Planned duration of breastfeeding < 3 months 14 (5) 4 (36) 2.50 12.14 2.07 to 71.19 0.02 3 to 6 months 103 (34) 4 (36) 6 months 184 (61) 3 (28) 1 Reference 0.38 Constant −0.77 0.46 0.68

Data reported as median (interquartile range) or n (%). *Unadjusted uni-variable P value. †Confounder adjusted for main effects multi-variable P value. ‡Odds for 25 μg change in cumulative epidural fentanyl. Area under the receiver operating characteristics (ROC) curve for the logistic regression model 0.82 (95% CI, 0.69 to 0.95). LATCH = Latch, Audible swallowing, Type of nipple, Comfort, and Hold/help; VRPS = verbal rating pain score.

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www.anesthesiology.org
https://www.apha.org/policies-and-advocacy/public-health-policy-statements/policy-database/2014/07/29/13/23/a-call-to-action-on-breastfeeding-a-fundamental-public-health-issue
https://www.apha.org/policies-and-advocacy/public-health-policy-statements/policy-database/2014/07/29/13/23/a-call-to-action-on-breastfeeding-a-fundamental-public-health-issue
https://www.apha.org/policies-and-advocacy/public-health-policy-statements/policy-database/2014/07/29/13/23/a-call-to-action-on-breastfeeding-a-fundamental-public-health-issue
http://biostat.mc.vanderbilt.edu/wiki/Main/BlockRandomizationWithRandomBlockSizes
http://biostat.mc.vanderbilt.edu/wiki/Main/BlockRandomizationWithRandomBlockSizes
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https://www.cdc.gov/breastfeeding/data/NIS_data/
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Anesthesiology 2017; 127:614-24 624 Lee et al.

Neuraxial Fentanyl and Breastfeeding

given intrathecally for labor analgesia. ANESTHESIOLOGY 2014; 120:1126–36

20. Sultan P, Murphy C, Halpern S, Carvalho B: The effect of low concentrations versus high concentrations of local anesthetics for labour analgesia on obstetric and anes- thetic outcomes: A meta-analysis. Can J Anaesth 2013; 60:840–54

21. Illinois Department of Public Health: Illinois hospital report card and consumer guide to health care. Available at: http://www.healthcarereportcard.illinois.gov/hospitals/ view/101281. Accessed April 6, 2017

22. Baby-Friendly USA, Inc.: Baby-friendly hospital initiative. Available at: https://www.babyfriendlyusa.org/about-us/ baby-friendly-hospital-initiative. Accessed April 6, 2017

Paine’s Celery Compound: Celery Seed Bracer or Cocaine Elixir?

Around 1874, a Yale medical graduate and Dartmouth professor, Edward Elisha Phelps, Sr., M.D., L.L.D. (1803 to 1880), compounded a remedy based on the celery seed (note the head of celery in the logo above). He eventually allowed his favorite compounding pharmacist, Milton Kendall Paine (1834 to 1896) to market the popular panacea as “The Best Remedy in the World—Paine’s Celery Compound.” In 1887 Paine sold his rights to Wells, Richardson & Company of Burlington, Vermont. That firm may have “enhanced” the compound with traces of cocaine and marketed it as “The True Medicine for Lost Nervous Strength.” After regulations in 1906, the compound likely joined Coca Cola in dropping cocaine from its formulation. Besides celery seed, the manufacturer’s later booklets listed Paine’s botanical slurry as comprising calisaya bark, cascara sagrada, senna leaves, prickly ash bark, hops, black haw, and chamomile flowers—all of which were added to the roots of sarsaparilla, ginger, dandelion, mandrake, gentian, black cohosh, and yellow dock. The American Medical Association categorized Paine’s compound as belonging “to the ‘bracer’ type of nostrums; that is, it is a preparation whose most potent and active drug is alcohol.” (Copyright © the American Society of Anesthesiologists’ Wood Library-Museum of Anesthesiology.)

George S. Bause, M.D., M.P.H., Honorary Curator and Laureate of the History of Anesthesia, Wood Library- Museum of Anesthesiology, Schaumburg, Illinois, and Clinical Associate Professor, Case Western Reserve University, Cleveland, Ohio. UJYC@aol.com.

ANESTHESIOLOGY REFLECTIONS FROM THE WOOD LIBRARY-MUSEUM

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http://www.healthcarereportcard.illinois.gov/hospitals/view/101281
https://www.babyfriendlyusa.org/about-us/baby-friendly-hospital-initiative
https://www.babyfriendlyusa.org/about-us/baby-friendly-hospital-initiative
mailto:UJYC@aol.com
Running head: ANTENATAL MUSIC 1

Effects of Music During Antenatal Testing

Susan Spockler

Jacksonville University

December 13, 2013

ANTENATAL MUSIC 2

Effects of Music During Antenatal Testing

Music can be used in a variety of ways to enhance and improve the care of antepartum

patients. Music is considered a complementary and alternative type of therapy. Kafali, Derbent,

Keskin, Simavli, and Gozdemir, (2011) looked at the effect music can have in decreasing anxiety

in pregnant women scheduled for a non-stress tests in the doctor’s office. The authors of this

article are affiliated with the department of Obstetrics and Gynecology from Faith University

Medical School in Ankara, Turkey.

This randomized study looked at a convenience sample of 201 pregnant women who

were scheduled non-stress testing at a Turkish prenatal clinic. There were two groups evaluated

in the study: the control group, which consisted of 105 women, and the experimental group,

which consisted of 96 women. The control group did not listen to music prior to having their

non-stress test performed. The experimental group listened to music before their non-stress test

began. Prior to the non-stress test, the participants’ anxiety levels were scored and evaluated.

Researchers attempted to control multiple extraneous factors including nutritional intake,

environmental noise, and interaction with clinic staff which may have affected maternal stress

levels. Following the non-stress test, anxiety levels for both control and experimental groups

were then re-evaluated.

The results of the study show that the anxiety level of the experiment group that listened

to music prior to the non-stress test was much lower than that of the control group, who did not

listen to any music prior to the non-stress test. The results from this study are applicable to

nursing practice because they show that music can have a positive effect in reducing stress in

pregnant women when having a test performed, such as the non-stress test. Music is easily

accessible and an affordable, easy way to help ease the anxiety of the antepartum women.

Comment [a1]: 4E

Comment [a2]: What data was gathered? How was it gathered? How was participant stress

measured? Biometric: B/P, pulse, blood cortisol??

Or psychometric with known surveys,

questionnaires, interviews? ?More specificity need here.

Comment [a3]: Are women stressed by having testing? Make the link between these two concepts.

ARTICLE REVIEW 3

Nurses have the ability to play a variety of music for their patients. Playing music is a simple

intervention can safely implement in their plan of care for patients (Kafali, et al., 2011).

ARTICLE REVIEW 4

References

Kafali, H., Derbent, A., Keskin, E., Simavli, S., & Gozdemir, E. (2011). Effect of maternal

anxiety and music on fetal movements and fetal heart rate patterns. Journal of Maternal-

Fetal & Neonatal Medicine, 24(3), 461-464. doi:10.3109/14767058.2010.501122

Susie, A nice, tight review. You included most of the elements required but did not address data

collection as much as I expected to see.

A very interesting article too. Thanks for sharing.

Article Critique

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