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Sleep aids to reduce pre-caesarean anxiety

Eye mask and earplugs as sleep aids to reduce pre-caesarean anxiety: a randomised sham-controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10438779
Enrollment
212
Registered
2025-11-21
Start date
2025-10-08
Completion date
Unknown
Last updated
2025-12-01

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

Conditions

Pre operative anxiety prior to a planned caesarean section Pregnancy and Childbirth

Interventions

The allocated intervention will take place during the period leading up to the date of scheduled caesarean section. All participants will be provided with the ActiGraph wGT3X-BT device (Pensacola, Fl

Sponsors

University Malaya Medical Centre
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Planned caesarean section (minimum of 3 days up to maximum of 14 days in advance) 2. Singleton pregnancy 3. Term pregnancy (=37 weeks at planned caesarean section) 4. Viable pregnancy

Exclusion criteria

Exclusion criteria: 1. Known psychiatric illnesses (e.g., depression, bipolar disorder, schizophrenia, etc.) 2. Known sleep disorders 3. Known anxiety disorders 4. Known hearing or vision impairments 5. Gross fetal anomalies 6. Perioperative complications anticipated (e.g., morbidly adherent placenta spectrum, anticipated major intraabdominal adhesions, etc.)

Design outcomes

Primary

MeasureTime frame
Anxiety score using PAS-7 questionnaire assessed within 24 hours of planned caesarean section.

Secondary

MeasureTime frame
1. Day 1 post operative pain score on movement (assessed on day 1 post caesarean section: 0-10 numerical rating scale) 2. Symptom assessment (assessed on day 1 post caesarean section: Yes/No response) on Nausea, Vomiting, Dizziness 3. Maternal satisfaction with intervention (assessed on day 1 post caesarean section: 0-10 numerical rating scale) 4. Post operative analgesia use (assessed on hospital discharge: through electronic medical records) 5. Mode of anaesthesia (assessed on hospital discharge: through electronic medical records) 6. Estimated blood loss (assessed on hospital discharge: through electronic medical records) 7. ICU admission (assessed on hospital discharge: through electronic medical records) 8. ICU admission indication (assessed on hospital discharge: through electronic medical records) 9. APGAR score at 1 minute (assessed on hospital discharge: through electronic medical records) 10. APGAR score at 5 minute (assessed on hospital discharge: through electronic medical records) 11. Birth Weight (assessed on hospital discharge: through electronic medical records) 12. Umbilical cord arterial blood pH (assessed on hospital discharge: through electronic medical records) 13. Umbilical cord arterial blood base excess (assessed on hospital discharge: through electronic medical records) 14. Neonatal admission (assessed on hospital discharge: through electronic medical records) 15. Neonatal admission indication(assessed on hospital discharge: through electronic medical records) 16. Length of hospital stay [admission until discharge] (assessed on hospital discharge: through electronic medical records) 17. DASS-21 score (assessed 6 weeks after delivery: through telephone assessment using DASS-21) 18. Exclusively breastfeeding status [“Exclusive breastfeeding means that the infant receives only breast milk. No other liquids or solids are given – not even water – with the exception of oral rehydration solution, or drops/syrups of vitamins, minerals or medici

Countries

Malaysia

Contacts

Public ContactSiang Wen Chew
22060979@siswa-old.um.edu.my+60 03-7949 4422, 010-9111500

Outcome results

None listed

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