Can ear plugs and eye masks improve sleep among pregnant mothers?
- Conditions
- Sleep disorders among pregnant ladiesPregnancy and Childbirth
- Registration Number
- ISRCTN28216612
- Lead Sponsor
- Obstetrics and Gynaecology Department, University Malaya Medical Center
- Brief Summary
2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36620851/ (added 27/02/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 56
1. Nulliparous
2. 34 – 36 weeks of gestation
3. Self-reported night sleep of less than 6 hours
4. Singleton pregnancy
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ight sleep duration, measured using actigraphy (Actisleep Device) over 7 consecutive nights
- Secondary Outcome Measures
Name Time Method <br> 1. Wake after sleep onset (WASO) and sleep efficiency (SE), measured using actigraphy (Actisleep Device) over 7 consecutive nights<br> 2. Labour outcomes, obtained from hospital delivery notes after delivery:<br> 2.1. Maternal:<br> 2.1.1. Mode of delivery<br> 2.1.2. Indication for Caesarean delivery<br> 2.1.3. Need for labor induction: prostaglandin or amiotomy<br> 2.1.4. Peridelivery blood loss<br> 2.1.5. Epidural requirement<br> 2.2. Fetal<br> 2.2.1. Birth weight<br> 2.2.2. Cord pH and base excess<br> 2.2.3. Apgar score at 5 minutes<br> 2.2.4. Neonatal admission and indication<br> 3. Maternal perception of sleep quality with sleep aid, measured using Likert scale at the end of the study<br>
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