Eye-Masks and Earplugs to Improve Night Sleep Duration in Nulliparas: A Randomized Trial

Abstract

BackgroundWomen experience significant sleep disruption throughout pregnancy. Lack of sleep during the last month of pregnancy is associated with longer labor, a higher rate of Cesarean births, gestational diabetes, hypertension, and preterm birth. Eye-mask and earplugs through sensory deprivation increase sleep duration and quality in patients in the intensive care environment but their impact at home or during pregnancy is not known. We sought to evaluate eye-mask and earplugs compared to sham/placebo headbands on night sleep duration in pregnancy. Materials and methodsA randomized trial was performed in a university hospital in Malaysia. Nulliparas between 34 and 36 weeks of gestation with self-reported night sleep of fewer than six hours were randomized to the use of eye-mask and earplugs or "sham" headbands during night sleep (both introduced as sleep aids). Night sleep duration was measured through a wrist actigraphy monitor during non-intervention week one and intervention week two with the allocated sleep aid. ResultsData from 56 participants were analyzed on an intention-to-treat basis. Mean night sleep duration increased in intervention week two compared to non-intervention week one in both trial arms, which were 279 ± 19 vs. 304 ± 19 minutes (mean increase of 25 minutes) p = <0.001 and 286 ± 21 vs. 302 ± 22 minutes (mean increase of 16 minutes) p = <0.001 for eye-masks-earplugs and headband respectively. However, the mean increase in night sleep duration across trial arms (p=0.13) was not significant. A higher proportion of participants in the eye-masks and earplugs arm had their night sleep duration increased by at least 30 minutes, 13/29 (45%) vs. 5/26 (19%), relative risk (RR) 2.3 (95% CI 1.0-5.6) p = 0.04, more likely to agree that they slept better 19/29 (66%) vs. 7/27 (26%), RR 2.2 (95% CI 1.1-4.6) p = 0.03, expressed higher satisfaction score with their sleep aid 7 (7.0-7.5) vs. 6 (5-7), p = 0.003 and had lower induction of labor rates 4/29 (14%) vs. 12/27 (44%), RR 0.3 (95%CI 0.1-0.8) p = 0.02. ConclusionEye masks and earplugs use in nulliparas with short night sleep duration in late pregnancy, lengthen their night sleep duration over baseline. Sleep is reportedly better and maternal satisfaction is higher with eye masks and earplugs use.

Eye-masks and earplugs compared to headband in nulliparas on increasing spontaneous vaginal delivery: a randomized trial

“…The primary outcome, spontaneous vaginal delivery rate although higher in the EMEP arm, the result (RR 1.15 95% CI 0.88–1.51) was not significant. The observed effect of EMEP on this outcome was smaller than that from pilot data (RR 1.2 95% CI 0.9–1.9) we used from Teo et al [ 10 ] for sample size calculation. In our present trial the mode of delivery outcome metric that showed the highest magnitude point estimate was for the reduction in cesarean delivery (RR 0.78 95% CI 0.57–1.06) but this also did not reach significance.…”

“…Nulliparas (no prior pregnancy beyond 20 weeks), aged ≥ 18 years, singleton pregnancy between 34 to 36 weeks gestation with self-reported night sleep of less than 6 h [ 10 , 20 ] and access to the telephone were identified for recruitment in the antenatal clinic during their regular visits. In our center, all women booked to deliver in our hospital attend the antenatal clinic.…”

“…Participants randomized to HB were instructed to wear it circumferentially at the level of the brow when they go to bed to sleep at night. The sleep aids were to be removed upon wakening [ 10 ]. Both EMEP and HB were characterized as sleep aids to participants as specified to our institution ethics review board for this approach.…”

“…On our primary outcome of spontaneous vaginal delivery rate, we used as pilot data the per protocol rates of 20/26 [76.9%] (EMEP) vs. 15/26 [57.7%] (HB) from Teo et al [ 10 ]. Applying power of 80%, alpha of 0.05, 1 to 1 ratio across trial arms and the Chi-square test for analysis, 93 participants were required in each arm for a trial powered to these metrics.…”

“…In an original trial report [ 10 ] of 56 women in late pregnancy done at our center, home-use of eye-masks and earplugs (EMEP) as sensory deprivation sleep aid and sham/placebo headband (HB) both significantly prolonged night sleep duration indicating an appreciable placebo effect of headbands as a purported sleep aid; a significantly higher proportion in EMEP arm prolonged their night sleep by at least 30 min (relative risk (RR) 2.3 95% CI 1.0–5.6) as per sleep actigraphy protocol and the point estimate for spontaneous vaginal delivery rates were 76.9% vs 57.7% (RR 1.2 95% CI 0.9–1.9), non-significantly higher for EMEP. EMEP improves sleep quality and sleep duration by 40–60% among patients nursed in intensive care unit [ 11 ].…”