Eye mask and earplugs to improve sleep after epidural analgesia during labour at night in first-time mothers

Eye mask and earplugs to improve sleep after epidural analgesia during nulliparous labour at night: a randomised controlled trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN93981030

Enrollment

126

Registered

2025-01-22

Start date

2025-03-31

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

Sleep duration during labour after epidural analgesia at night Pregnancy and Childbirth

Interventions

Patient recruitment will take place in the Labour Ward of University of Malaya Medical Centre (UMMC) at epidural analgesia or within an hour of its insertion timed from 1800 to 0600 hours. Consented p

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. 18 years old and above 2. Nulliparous (no prior pregnancy >22 weeks) 3. Singleton pregnancy 4. 37 weeks of gestation and above 5. Epidural analgesia sited from 1800H to 0600H 6. Cervical dilatation less than 6 cm 7. Normal fetal heart rate tracing

Exclusion criteria

Exclusion criteria: 1. Need for frequent monitoring 2. Known sleep disorders 3. Major hearing (using hearing aids) or visual impairment (refractive errors acceptable) 4. Gross fetal anomalies 5. Intrauterine fetal death

Design outcomes

Primary

Measure	Time frame
Sleep duration measured using actigraphy data assessed after delivery	—

Secondary

Measure	Time frame
1. Intervention to delivery interval as recorded from the patient’s electronic medical record after delivery 2. Maternal satisfaction with sleep during labour measured using a 0-10 numerical rating scale after delivery 3. Mode of delivery from patient’s electronic medical record after delivery 4. Indication for operative delivery (Caesarean and instrumental vaginal delivery) from patient’s electronic medical record after delivery 5. Perineal condition from patient’s electronic medical record after delivery 6. Estimated delivery blood loss from patient’s electronic medical record after delivery 7. Birth weight from patient’s electronic medical record after delivery 8. Apgar score at 1 and 5 minutes from offspring’s electronic medical record after delivery 9. Umbilical cord artery blood pH and BE from offspring’s electronic medical record after delivery 10. Neonatal admission from offspring’s electronic medical record after delivery 11. Indication for neonatal admission from offspring’s electronic medical record after delivery	—

Measure

Time frame

1. Intervention to delivery interval as recorded from the patient’s electronic medical record after delivery 2. Maternal satisfaction with sleep during labour measured using a 0-10 numerical rating scale after delivery 3. Mode of delivery from patient’s electronic medical record after delivery 4. Indication for operative delivery (Caesarean and instrumental vaginal delivery) from patient’s electronic medical record after delivery 5. Perineal condition from patient’s electronic medical record after delivery 6. Estimated delivery blood loss from patient’s electronic medical record after delivery 7. Birth weight from patient’s electronic medical record after delivery 8. Apgar score at 1 and 5 minutes from offspring’s electronic medical record after delivery 9. Umbilical cord artery blood pH and BE from offspring’s electronic medical record after delivery 10. Neonatal admission from offspring’s electronic medical record after delivery 11. Indication for neonatal admission from offspring’s electronic medical record after delivery

—

Countries

Malaysia

Contacts

Public ContactLela Nadia Khalid

lelanadiakhalid@gmail.com+60 (0)10-4480602

Outcome results

None listed

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