Sleep aids to reduce pre-caesarean anxiety
| ISRCTN | ISRCTN10438779 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10438779 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 2025119-14622 |
| Sponsor | University Malaya Medical Centre |
| Funder | Universiti Malaya |
- Submission date
- 13/10/2025
- Registration date
- 21/11/2025
- Last edited
- 13/11/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
This study will test whether simple sleep aids can lower anxiety before a planned caesarean section by helping pregnant patients sleep better in the days leading up to surgery.
Many people feel anxious before surgery, and this worry can worsen pain, nausea, and overall recovery after the operation. Non-drug options are attractive because they are low risk and have less side effects. Improving sleep is linked to better mental health and less anxiety in general. This study aims to find out if wearing an eye mask and earplugs at night can improve sleep and, in turn, reduce anxiety before a planned caesarean section compared with a sham headband control.
Who can participate?
Adults with a singleton, term pregnancy (37 weeks or more) who have a planned caesarean section scheduled 3 to 14 days ahead are eligible to be assessed for the study. People will not be able to take part if there are known psychiatric or anxiety disorders, known sleep disorders, significant hearing or vision problems, fetal anomalies, or anticipated surgical complications such as placenta accreta or extensive adhesions.
What does the study involve?
Participants are randomly assigned by computer to one of two groups: eye mask and earplugs each night, or an elastic headband as a sham control, during the days before surgery until hospital admission for the caesarean section. Everyone will wear a wrist actigraph that looks like a watch during sleep to objectively measure sleep and will also keep a simple daily sleep diary of bedtimes, wake times, and estimated sleep duration. On admission for surgery, the team will collect the device and diary, and participants will complete a short questionnaire about preoperative anxiety (Perioperative Anxiety Scale‑7) and rate satisfaction with the sleep aid. After the surgery, further outcomes such as pain on the day after surgery, symptoms of nausea, vomiting and dizziness, and breastfeeding status at six weeks will be collected from records or brief follow-up calls as described in the protocol and information sheet.
What are the possible benefits and risks of participating?
Potential benefits include better sleep and lower anxiety before surgery, and possibly a more comfortable recovery, though direct personal benefit cannot be guaranteed. Risks are expected to be minimal. Eye masks, earplugs, and headbands are commonly used and are not anticipated to cause harm, but any unexpected issues will be reviewed by the department’s research oversight panel.
Where is the study run from?
The study is managed by the Department of Obstetrics and Gynaecology at University of Malaya Medical Centre (UMMC) (Malaysia), with recruitment in the antenatal clinic and inpatient assessment at the antenatal ward upon admission for the planned caesarean section.
When is the study starting and how long is it expected to run for?
January 2025 to August 2026
Who is funding the study?
The Department of Obstetrics and Gynaecology, UMMC will cover study-related costs such as devices, data management, and analysis.
Who is the main contact?
Dr Chew Siang Wen (Department of Obstetrics and Gynaecology, UMMC), 22060979@siswa.um.edu.my
Contact information
Public, Scientific, Principal investigator
Universiti Malaya Medical Centre, Jalan Profesor Diraja Ungku Aziz, Seksyen 13
Petaling Jaya
50603
Malaysia
| Phone | +60 03-7949 4422, 010-9111500 |
|---|---|
| 22060979@siswa-old.um.edu.my |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized controlled trial single centre parallel group |
| Secondary study design | Randomised controlled trial |
| Participant information sheet | 48173 PARTICIPANT_INFORMATION_SHEET_chew version 2.pdf |
| Scientific title | Eye mask and earplugs as sleep aids to reduce pre-caesarean anxiety: a randomised sham-controlled trial |
| Study acronym | SERENE |
| Study objectives | To evaluate eye mask and earplugs as sleep aids in improving anxiety 24 hour before planned caesarean section |
| Ethics approval(s) |
Submitted 22/07/2025, UMMC–Medical Research Ethics Committee (UMMC‑MREC) (UMMC‑MREC Secretariat, Menara Utama/Kompleks Pendidikan Sains Kejururawatan, Pusat Perubatan Universiti Malaya, Lembah Pantai, Kuala Lumpur, 59100, Malaysia; +60 03‑7949 3209 / 2251 / 8473 / 4656; ummc-mrec@ummc.edu.my), ref: 2025119-14622 |
| Health condition(s) or problem(s) studied | Pre operative anxiety prior to a planned caesarean section |
| Intervention | 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, Florida, USA) and instructed on its use. The device is to be worn like a wristwatch, and participants are asked to wear it to sleep at night up until the day of their planned caesarean section. They will be told to record in a sleep dairy their ‘time to bed’ and ‘time out of bed’ as well as their own estimated total sleep time. Participants randomised to EMEP shall wear the eye mask and earplugs before going to sleep each night. If the patient has to mobilise, EMEP can be removed and to be replaced on returning to bed. Participants randomised to the control arm shall wear the elasticated headband before going to sleep each night and to remove it on awakening to get out of bed. The headband serves as a sham/placebo control. Upon admission for planned caesarean section, the sleep diary and actigraph watch will be retrieved and participant’s PAS-7 scores and satisfaction post intervention recorded. The ‘Time to bed’ and ‘Time out of bed’ (TOB) recorded will be used for calculation of sleep duration using the ActiLife software later. The randomisation sequence will be generated using https://www.sealedenvelope.com/simple-randomiser/v1/lists, in blocks of 4 or 8, in 1 to 1 ratio, by a co-investigator who will not be involved in the recruitment process. Allocation will be sealed within a numbered opaque envelope. Randomisation will be implemented using strict sequential opening of the lowest-numbered remaining sealed envelopes for the latest recruit. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Anxiety score using PAS-7 questionnaire assessed within 24 hours of planned caesarean section. |
| Key secondary outcome measure(s) |
1. Day 1 post operative pain score on movement (assessed on day 1 post caesarean section: 0-10 numerical rating scale) |
| Completion date | 01/08/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 50 Years |
| Sex | Female |
| Target sample size at registration | 212 |
| Key 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 |
| Key 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.) |
| Date of first enrolment | 08/10/2025 |
| Date of final enrolment | 01/08/2026 |
Locations
Countries of recruitment
- Malaysia
Study participating centre
Petaling Jaya
50603
Malaysia
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. 22060979@siswa-old.um.edu.my Where will the data be kept? Manual records: stored in secured locker with a lock in Obstetrics and Gynaecology Department UMMC. The key will be kept only by primary investigator Digital records” password-protected computers accessible only to researchers Who will have access to the research data? Principle investigator and approved co-investigators How long will the data be kept? (suggestion: at least 7 years) Minimum of 7 years after completion of the study |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 2 | 10/11/2025 | No | Yes | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version 2 | 06/08/2025 | 10/11/2025 | No | No |
Additional files
- 48173 PARTICIPANT_INFORMATION_SHEET_chew version 2.pdf
- Participant information sheet
- 48173 UMMC MREC RESEARCH PROTOCOL chew version 2 06Aug2025.pdf
- Protocol file
Editorial Notes
13/11/2025: Trial's existence confirmed by UMMC–Medical Research Ethics Committee (UMMC‑MREC).
