Use of eye masks and earplugs compared with standard advice to improve sleep in pregnancy
| ISRCTN | ISRCTN19061849 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN19061849 |
| Secondary identifying numbers | 202131-9894 |
- Submission date
- 03/05/2021
- Registration date
- 07/05/2021
- Last edited
- 24/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
Short sleep duration in pregnancy has been associated with poor pregnancy outcomes like longer labour, developing gestational diabetes or hypertension (high blood pressure), preterm birth and Caesarean birth. Sleep problems are very common in pregnancy. It may be possible to reduce these adverse pregnancy outcomes by improving sleep and finding sleep aids that can achieve that. This study aims to evaluate eye-masks and earplugs use at home to increase night sleep duration in pregnant women with short sleep at 34-36 weeks of pregnancy. Alternatively, the researchers will provide an advice leaflet to lengthen sleep. They want to find out if eye masks and earplugs are effective as a sleep aid.
Who can participate?
Pregnant women between 34 and 36 weeks gestation who report a short night sleep duration of fewer than 6 hours and fulfil other criteria
What does the study involve?
Participants will be asked to wear a wristwatch-like device when they go to bed at night. This device detects movement (actigraphy) and the information will be downloaded to give the night sleep duration. Participants will need to record in a diary the time they go to bed to sleep and the time they wake to get out of bed. This information is needed by the actigraphy software to work out night sleep duration. At the end of Week 1, participants will need to return for actigraphy data to be downloaded and analysed. They can continue to intervention week 2 if a minimum of 3 nights sleep data can be obtained from the 7 nights of recordings, and the average night sleep duration recorded is less than 6 hours. If assigned to the control group, participants will be asked to read the advice leaflet supplied at the beginning of intervention Week 2, and if assigned to the intervention group, they will need to use the eye-mask and earplugs when they go to bed at night for the next 7 nights.
What are the possible benefits and risks of participating?
There may or may not be any benefits to participants. Information obtained from this study will help improve the treatment or management of other patients with the same disease or condition. The use of the eye mask and earplugs is not expected to have any adverse effect during pregnancy.
Where is the study run from?
University of Malaya Medical Centre (UMMC) (Malaysia)
When is the study starting and how long is it expected to run for?
April 2021 to August 2022
Who is funding the study?
University of Malaya Medical Centre (UMMC) (Malaysia)
Who is the main contact?
Dr Farah binti Mohd Faiz Gan
farah.faizg@ummc.edu.my
Contact information
Public
Department of Obstetrics & Gynaecology
Kompleks Kesihatan Wanita dan Kanak-Kanak
University Malaya Medical Centre
Jalan Universiti, Lembah Pantai
Kuala Lumpur
59100
Malaysia
| Phone | +60 (0)176345907 |
|---|---|
| farah.faizg@ummc.edu.my |
Scientific
Department of Obstetrics & Gynaecology
Kompleks Kesihatan Wanita dan Kanak-Kanak
University Malaya Medical Centre
Jalan Universiti, Lembah Pantai
Kuala Lumpur
59100
Malaysia
| Phone | +60 (0)176345907 |
|---|---|
| farah.faizg@ummc.edu.my |
Study information
| Study design | Single-centre interventional open randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN19061849_PIS_v1_01Mar2021.pdf |
| Scientific title | Eye masks and earplugs compared with advice leaflet to improve night sleep duration in pregnancy: a randomised controlled trial |
| Study acronym | EMEP2 |
| Study objectives | Home use eye masks and earplugs will increase actigraphy-derived night sleep duration among nulliparas and multiparas in their late third trimester. |
| Ethics approval(s) | Approved 26/04/2021, University of Malaya Medical Centre-Medical Research Ethics Committee (UMMC-MREC, 2nd floor, Kompleks Pendidikan Sains Kejururawatan, Pusat Perubatan Universiti Malaya 59100 Kuala Lumpur, Malaysia; +60 (0)3 7949 3209 / 2251 / 8473 / 4656; ummc-mrec@ummc.edu.my), ref: 202131-9894 |
| Health condition(s) or problem(s) studied | Night sleep duration among sleep-deprived nulliparas and multiparas in their late third trimester |
| Intervention | Patient recruitment will take place in the antenatal clinic of the University of Malaya Medical Centre (UMMC). Suitability of recruitment into the trial will be assessed through patients’ antenatal records and the use of the eligibility assessment form (EAF). Nullipara and multipara at a gestational age between 34 to 36 weeks, with a singleton pregnancy, and self-reported night sleep duration of less than 6 hours will be included. Potential participants will be asked to fill in the Pittsburgh Sleep Quality Index (PSQI), a widely used and well-validated 19-item self-report instrument that measures sleep disturbances in adults. Exclusion criteria are patients with pre-existing sleep, psychiatric, or medical disorders, any ear/eye injury resulting in the participant not being able to wear the earplugs/eye-mask, active smokers, current alcohol consumption, body mass index above 35, multipara with co-sleeping child/children, night shift workers, care-taker of other family members, known gross foetal anomalies, or intrauterine fetal death. These criteria ensured similar sleep conditions between groups. Eligible women will be provided with the Patient Information Sheet [PIS] and verbally counselled with regard to trial participation - they will receive eye masks and earplugs [EMEP] or advice leaflet [AL], to help improve their sleep. Written informed consent will be obtained, and their relevant details and characteristics transcribed onto the Case Report Form [CRF]. All participants will then be provided with the ActiGraph wGT3X-BT device (Pensacola, Florida, USA) and instructed on its use. Participants will be informed that their self-reported short sleep will first be verified by a wristband actigraphy monitor. The device is to be worn like a wristwatch, and participants are asked to wear it to sleep at night for 7 consecutive nights (Baseline Week 1). They will be told to record their ‘Time In Bed’ (TIB) and ‘Time Out of Bed’ (TOB) for sleep, for calculation of sleep duration using the ActiLife software later. After seven days (Baseline Week 1), participants will need to return with their devices for data retrieval. They will only be allowed to proceed with the intervention portion of the trial if the device confirmed a mean night sleep duration of less than 6 hours from a minimum of 3 nights’ worth of sleep data retrievable. For intervention Week 2, still eligible participants will be randomised. Allocation will be specified within a sealed numbered opaque envelope. Randomisation sequence for the numbering of these envelopes will be generated separately for nulliparas and multiparas online using random.org, in blocks of 4 or 8, following a 1 to 1 ratio, by a co-investigator who will not be involved in the recruitment process. Randomisation will be implemented using strict sequential opening of the lowest-numbered remaining sealed envelopes. The intervention group will be provided with eye-masks and earplugs (EMEP). The eye mask and earplugs are to be used for 7 consecutive nights when in bed for sleep concurrent with the ActiGraph wGT3X-BT device. The eye mask and earplugs can be removed when participants mobilise during the night, but to be re-worn on returning to bed to sleep. The eye mask, earplugs and the ActiGraph wGT3X-BT device are to be removed on the morning awakening. Participants in the control group will be given an ad hoc trial advice leaflet (AL) on sleep, comprising the following advice; 1. Adopt a regular sleep schedule 2. Avoid caffeine, nicotine, alcoholic drinks and excessive fluid volume before bed 3. Exercise regularly 4. Avoid distraction in bed (television, computer, smartphones, tablets) 5. Set consistent, healthy mealtimes 6. Don’t go to bed until you are sleepy, gradually move to an earlier bedtime Instructions on ActiGraph wGT3X-BT device use into intervention Week 2 will be reinforced for all participants. On their second return visit after intervention Week 2, participants will be asked to return their devices. Data will be retrieved and analysed from these devices. The participants will also once again be asked to complete the Pittsburgh Sleep Quality Index (PSQI). |
| Intervention type | Mixed |
| Primary outcome measure | Night sleep duration measured using the Actigraph wGT3X-BT device at the end of Week 1 (baseline) and Week 2 (intervention) |
| Secondary outcome measures | 1. Labour outcomes retrieved from patients’ records post-delivery: 1.1. Mode of delivery 1.2. Need for labour induction (mechanical induction, prostaglandin, amniotomy) 1.3. Peri-delivery blood loss 1.4. Epidural requirement 2. Neonatal outcomes retrieved from patients’ records post-delivery: 2.1. Birth weight 2.2. Cord pH and base excess 2.3. Apgar score at 5 minutes 2.4. Neonatal admission and indication 3. Subjects’ sleep satisfaction with the sleep aid measured using the Pittsburgh Sleep Quality Index (PSQI) during recruitment, and the modified Pittsburgh Sleep Quality Index at the end of Week 2 (after intervention) |
| Overall study start date | 01/04/2021 |
| Completion date | 31/08/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 208 |
| Key inclusion criteria | 1. Nullipara (no prior pregnancy beyond 20 weeks gestation) 2. Multipara 3. 34 – 36 weeks of gestation 4. Self-reported sleep of fewer than 6 hours 5. Singleton pregnancy |
| Key exclusion criteria | 1. Pre-existing sleep disorders: chronic insomnia, sleep apnea 2. Pre-existing psychiatric disorders: depression, schizophrenia etc 3. Pre-existing medical disorders: systemic lupus erythematosus, thyroid disorders, epilepsy, heart diseases etc. 4. Any ear/eye injury resulting in the participant not being able to wear the earplugs/eye-mask 5. Active smoker 6. Current alcohol consumption 7. Obesity >class II (body mass index >35) 8. Multipara with co-sleeping child/children 9. Night shift workers 10. Night care-taker of other family members 11. Gross fetal anomalies 12. Intrauterine fetal death |
| Date of first enrolment | 08/06/2021 |
| Date of final enrolment | 31/07/2022 |
Locations
Countries of recruitment
- Malaysia
Study participating centre
Kuala Lumpur
59100
Malaysia
Sponsor information
Hospital/treatment centre
Department of Obstetrics & Gynaecology
University Malaya Medical Centre
Jalan Universiti, Lembah Pantai
Kuala Lumpur
59100
Malaysia
| Phone | +60 (0)379494422 |
|---|---|
| ummc@ummc.edu.my | |
| Website | https://www.um.edu.my/ |
"ROR" |
https://ror.org/00vkrxq08 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 30/04/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Farah binti Mohd Faiz Gan (farah.faizg@ummc.edu.my). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version v1 | 01/03/2021 | 01/06/2021 | No | Yes |
| Protocol file | 01/06/2021 | No | No | ||
| Results article | 01/12/2023 | 24/06/2024 | Yes | No |
Additional files
- ISRCTN19061849_PIS_v1_01Mar2021.pdf
- Uploaded 01/06/2021
- ISRCTN19061849_PROTOCOL.pdf
- Uploaded 01/06/2021
Editorial Notes
24/06/2024: Publication reference added.
20/03/2023: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/06/2021 to 08/06/2021.
2. The recruitment end date was changed from 30/04/2022 to 31/07/2022.
3. The overall end date was changed from 31/12/2022 to 31/08/2022.
4. The plain English summary was updated to reflect these changes.
01/06/2021: The following changes have been made:
1. Uploaded protocol file (not peer reviewed).
2. The participant information sheet has been uploaded as an additional file.
06/05/2021: Trial's existence confirmed by the University of Malaya Medical Centre - Medical Research Ethics Committee.
