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Can an eye mask and earplugs compared to a headband help to improve night sleep and spontaneous vaginal delivery in nulliparas?

A randomized controlled trial on eye mask and earplugs compared to headband to improve night sleep and spontaneous vaginal delivery in nulliparas

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN99834087
Enrollment
234
Registered
2019-06-11
Start date
2019-12-16
Completion date
Unknown
Last updated
2023-06-05

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

Conditions

Spontaneous vaginal delivery among nulliparas Pregnancy and Childbirth

Interventions

Nulliparas who are at 34 - 36 weeks who attend the antenatal clinic in UMMC will be approached regarding this study. A patient information sheet will be provided for those who fulfil the initial eligi

Sponsors

University Malaya Medical Centre
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Nulliparous (no prior pregnancy = 20 weeks) 2. 34-36 weeks of gestation 3. Self-reported sleep less than 6 hours 4. Singleton pregnancy 5. Access to the phone

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 disease 4. Planned caesarean delivery (e.g. placenta praevia , breech, maternal request) 5. Night shift workers or night care commitments 6. Active smoker 7. Current alcohol consumption 8. Maternal obesity >class II (BMI>35) 9. Intrauterine death 10. Care taker of other family members 11. Gross fetal anomaly

Design outcomes

Primary

MeasureTime frame
Spontaneous vaginal delivery assessed using questionnaire in the data collection form upon delivery

Secondary

MeasureTime frame
Night sleep assessed using questionnaire form after 2 weeks

Countries

Malaysia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 9, 2026