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眼罩和耳塞与睡眠建议手册对改善孕期夜间睡眠时间的比较:一项随机对照试验

Eye-mask and earplugs compared with sleep advice leaflet to improve night sleep duration in pregnancy: a randomized controlled trial.

作者信息

Gan Farah, Sooriappragasarao Muginrarao, Sulaiman Sofiah, Razali Nuguelis, Hong Jesrine Gek Shan, Tan Peng Chiong

机构信息

Department of Obstetrics and Gynecology, Faculty of Medicine, University Malaya, Kuala Lumpur, Malaysia.

出版信息

Sleep. 2023 Dec 11;46(12). doi: 10.1093/sleep/zsad196.

DOI:10.1093/sleep/zsad196
PMID:37478474
Abstract

STUDY OBJECTIVES

To evaluate at-home use of eye-mask and earplugs (EMEP) versus sleep hygiene advice leaflet (AL) on actigraphy-derived night sleep duration in sleep-deprived pregnant women.

METHODS

A randomized controlled trial was conducted in the antenatal clinic of University Malaya Medical Centre from June 2021 to June 2022. Women at 34-36 weeks gestation with self-reported night sleep duration ≤6 hours were recruited. Participants wore an actigraphy device at night for seven consecutive nights (Observation/Baseline week). Only women whose actigraphy-derived night sleep duration was confirmed to be ≤360 minutes were randomized to use EMEP or AL. Actigraphy was continued for another week (Intervention week). Primary outcome was change in actigraphy-derived night sleep duration from observation to intervention week across trial arms. Secondary outcomes include participants' sleep quality, labor, and neonatal outcome. Comparisons were by Student t-test, Mann-Whitney U test, and chi-square test.

RESULTS

A total of 210 women were randomized: 105 each to EMEP and AL. The increase in night sleep duration over baseline was significantly longer with both EMEP (mean ± SD) 23 ± 41 minutes, p < .001, and AL 10 ± 35 minutes, p = .007. Night sleep duration was longer by 12.9 (95% CI = 2.2 to 23.7) minutes, p = .019 with EMEP over AL. Sleep quality (Global Pittsburgh Sleep Quality Index score) was significantly improved with EMEP (mean ± SD) -2.0 ± 2.5, p < .001, but not with AL -0.3 ± 2.2, p = .246. Labor and neonatal outcomes were not significantly different.

CONCLUSION

EMEP significantly lengthened night sleep duration in sleep-deprived women in late pregnancy and is superior to AL.

CLINICAL TRIAL INFORMATION

"Use of eye masks and earplugs compared with standard advice to improve sleep in pregnancy". https://doi.org/10.1186/ISRCTN19061849. Registered with ISRCTN on 07 May 2021, trial identification number: ISRCTN19061849.

摘要

研究目的

评估睡眠不足的孕妇在家使用眼罩和耳塞(EMEP)与睡眠卫生建议手册(AL)对通过活动记录仪得出的夜间睡眠时间的影响。

方法

2021年6月至2022年6月在马来亚大学医学中心的产前诊所进行了一项随机对照试验。招募了妊娠34 - 36周、自我报告夜间睡眠时间≤6小时的女性。参与者连续七个晚上在夜间佩戴活动记录仪(观察/基线周)。只有通过活动记录仪得出的夜间睡眠时间被确认为≤360分钟的女性才被随机分配使用EMEP或AL。活动记录仪监测持续另一周(干预周)。主要结局是各试验组从观察周到干预周通过活动记录仪得出的夜间睡眠时间的变化。次要结局包括参与者的睡眠质量、分娩情况和新生儿结局。采用学生t检验、曼 - 惠特尼U检验和卡方检验进行比较。

结果

共有210名女性被随机分组:EMEP组和AL组各105名。EMEP组(均值±标准差)夜间睡眠时间较基线的增加显著更长,为23±41分钟,p <.001,AL组为10±35分钟,p =.007。EMEP组比AL组夜间睡眠时间长12.9(95%可信区间 = 2.2至23.7)分钟,p =.019。EMEP组睡眠质量(匹兹堡睡眠质量指数总分)显著改善(均值±标准差)-2.0±2.5,p <.001,而AL组未改善,为-0.3±2.2,p =.246。分娩情况和新生儿结局无显著差异。

结论

EMEP显著延长了妊娠晚期睡眠不足女性夜间睡眠时间,且优于AL。

临床试验信息

“使用眼罩和耳塞与标准建议相比改善孕期睡眠”。https://doi.org/10.1186/ISRCTN19061849。于2021年5月7日在ISRCTN注册,试验识别号:ISRCTN19061849。

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