Use of eye masks and earplugs compared with standard advice to improve sleep in pregnancy

Eye masks and earplugs compared with advice leaflet to improve night sleep duration in pregnancy: a randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN19061849

Enrollment

208

Registered

2021-05-07

Start date

2021-06-08

Completion date

Unknown

Last updated

2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Night sleep duration among sleep-deprived nulliparas and multiparas in their late third trimester Pregnancy and Childbirth

Interventions

Patient recruitment will take place in the antenatal clinic of the University of Malaya Medical Centre (UMMC). Suitability of recruitment into the trial will be assessed through patients’ antenatal re

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Nullipara (no prior pregnancy beyond 20 weeks gestation) 2. Multipara 3. 34 – 36 weeks of gestation 4. Self-reported sleep of fewer than 6 hours 5. Singleton pregnancy

Exclusion criteria

Exclusion criteria: 1. Pre-existing sleep disorders: chronic insomnia, sleep apnea 2. Pre-existing psychiatric disorders: depression, schizophrenia etc 3. Pre-existing medical disorders: systemic lupus erythematosus, thyroid disorders, epilepsy, heart diseases etc. 4. Any ear/eye injury resulting in the participant not being able to wear the earplugs/eye-mask 5. Active smoker 6. Current alcohol consumption 7. Obesity >class II (body mass index >35) 8. Multipara with co-sleeping child/children 9. Night shift workers 10. Night care-taker of other family members 11. Gross fetal anomalies 12. Intrauterine fetal death

Design outcomes

Primary

Measure	Time frame
Night sleep duration measured using the Actigraph wGT3X-BT device at the end of Week 1 (baseline) and Week 2 (intervention)	—

Secondary

Measure	Time frame
1. Labour outcomes retrieved from patients’ records post-delivery: 1.1. Mode of delivery 1.2. Need for labour induction (mechanical induction, prostaglandin, amniotomy) 1.3. Peri-delivery blood loss 1.4. Epidural requirement 2. Neonatal outcomes retrieved from patients’ records post-delivery: 2.1. Birth weight 2.2. Cord pH and base excess 2.3. Apgar score at 5 minutes 2.4. Neonatal admission and indication 3. Subjects’ sleep satisfaction with the sleep aid measured using the Pittsburgh Sleep Quality Index (PSQI) during recruitment, and the modified Pittsburgh Sleep Quality Index at the end of Week 2 (after intervention)	—

Measure

Time frame

1. Labour outcomes retrieved from patients’ records post-delivery: 1.1. Mode of delivery 1.2. Need for labour induction (mechanical induction, prostaglandin, amniotomy) 1.3. Peri-delivery blood loss 1.4. Epidural requirement 2. Neonatal outcomes retrieved from patients’ records post-delivery: 2.1. Birth weight 2.2. Cord pH and base excess 2.3. Apgar score at 5 minutes 2.4. Neonatal admission and indication 3. Subjects’ sleep satisfaction with the sleep aid measured using the Pittsburgh Sleep Quality Index (PSQI) during recruitment, and the modified Pittsburgh Sleep Quality Index at the end of Week 2 (after intervention)

—

Countries

Malaysia

Contacts

Public ContactFarah Mohd Faiz Gan

farah.faizg@ummc.edu.my+60 (0)176345907

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 8, 2026