Can an eye mask and earplugs compared to a headband help to improve night sleep and spontaneous vaginal delivery in nulliparas?
- Conditions
- Spontaneous vaginal delivery among nulliparasPregnancy and Childbirth
- Registration Number
- ISRCTN99834087
- Lead Sponsor
- niversity Malaya Medical Centre
- Brief Summary
2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37226087/ (added 25/05/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 234
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Spontaneous vaginal delivery assessed using questionnaire in the data collection form upon delivery
- Secondary Outcome Measures
Name Time Method ight sleep assessed using questionnaire form after 2 weeks