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Can ear plugs and eye masks improve sleep among pregnant mothers?

Ear plugs and eye mask to improve night sleep duration in nulliparas: a randomised control trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN28216612
Enrollment
50
Registered
2018-01-15
Start date
2018-02-01
Completion date
Unknown
Last updated
2023-03-13

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

Conditions

Sleep disorders among pregnant ladies Pregnancy and Childbirth

Interventions

Nulliparas who are at 34 – 36 weeks who attend Antenatal clinic in UMMC and reported night sleep duration of 5 hours or less on average in the last 1 month will be informed regarding this study. The p

Sponsors

Obstetrics and Gynaecology Department, University Malaya Medical Center
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Nulliparous 2. 34 – 36 weeks of gestation 3. Self-reported night sleep of less than 6 hours 4. Singleton pregnancy

Exclusion criteria

Exclusion criteria: 1. Patients with known pre-existing sleep disorders: chronic insomnia, sleep apnea 2. Patients with known pre-existing psychiatric disorders, e.g. depression, schizophrenia etc 3. Patients with underlying medical disorders: SLE, thyroid disorders, epilepsy, heart diseases etc 4. Night shift workers 5. Active smoker 6. Current alcoholic consumption 7. Obesity > class II (BMI > 35) 8. Intrauterine death

Design outcomes

Primary

MeasureTime frame
Night sleep duration, measured using actigraphy (Actisleep Device) over 7 consecutive nights

Secondary

MeasureTime frame
1. Wake after sleep onset (WASO) and sleep efficiency (SE), measured using actigraphy (Actisleep Device) over 7 consecutive nights 2. Labour outcomes, obtained from hospital delivery notes after delivery: 2.1. Maternal: 2.1.1. Mode of delivery 2.1.2. Indication for Caesarean delivery 2.1.3. Need for labor induction: prostaglandin or amiotomy 2.1.4. Peridelivery blood loss 2.1.5. Epidural requirement 2.2. Fetal 2.2.1. Birth weight 2.2.2. Cord pH and base excess 2.2.3. Apgar score at 5 minutes 2.2.4. Neonatal admission and indication 3. Maternal perception of sleep quality with sleep aid, measured using Likert scale at the end of the study

Countries

Malaysia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026