Can an eye mask and earplugs compared to a headband help to improve night sleep and spontaneous vaginal delivery in nulliparas?
| ISRCTN | ISRCTN99834087 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99834087 |
| Secondary identifying numbers | NMRR-19-590-47577 |
- Submission date
- 28/05/2019
- Registration date
- 11/06/2019
- Last edited
- 25/05/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
75% of pregnant women experience some form of sleep disruption during pregnancy. The rate of sleep disturbances also increases across trimesters, ranging from 13% in the first trimester, 19% in the second, and 66% in the third. Lack of sleep in the third trimester has a detrimental effect on pregnancy outcomes. Women who reported less than 6 hours of sleep per night during the last month of pregnancy had a significantly longer mean duration of labour and a higher rate of caesarean births. Women who slept less than 7 hours at night are at increased risk of developing gestational diabetes, gestational hypertension and preterm birth. Eye masks and earplugs may help to improve spontaneous vaginal delivery among women who have never given birth before (nulliparas) in their third trimester. The aim of this study is to assess the impact of eye masks and earplugs compared to a headband as sleep aids among 34 to 36 weeks nulliparas.
Who can participate?
Nulliparas who attend the Antenatal Clinic at University Malaya Medical Centre, who sleep for less than 6 hours a night
What does the study involve?
Participants are randomly allocated to the intervention group or the sham method group. The intervention group are provided with eye masks and earplugs to wear when they go to bed at night up until the delivery. They may remove the eye masks and earplugs temporarily if they wake up from sleep at night. The sham method group are provided with an elasticated headband to wear when they go to bed at night up until the delivery. The headband shall be placed on their forehead loosely. At the end of 2 weeks, participants receive a call from the investigator to assess their sleep quality using a questionnaire. Participants are followed up until delivery to assess the rate of spontaneous vaginal delivery.
What are the possible benefits and risks of participating?
Patients may have improved sleep with sleeping aids and thus improved spontaneous vaginal delivery. There are no risks involved.
Where is the study run from?
University Malaya Medical Centre (Malaysia)
When is the study starting and how long is it expected to run for?
June 2019 to July 2020
Who is funding the study?
University Malay Medical Centre (Malaysia)
Who is the main contact?
1. Dr Vimaladevi Annamalai
devi_vimala25@siswa.um.edu.my
2. Prof. Tan Peng Chiong
tanpengchiong@yahoo.com
Contact information
Scientific
University Malaya Medical Centre
Lembah Pantai
Kuala Lumpur
50603
Malaysia
| Phone | +60 (0)3 79494422 |
|---|---|
| devi_vimala25@siswa.um.edu.my |
Scientific
University Malaya Medical Centre
Jalan Univeristy
Lembah Pantai
Kuala Lumpur
50603
Malaysia
| Phone | +60 (0)123052970 |
|---|---|
| tanpengchiong@yahoo.com |
Study information
| Study design | Prospective randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A randomized controlled trial on eye mask and earplugs compared to headband to improve night sleep and spontaneous vaginal delivery in nulliparas |
| Study objectives | Use of earplugs and eye masks at 34-36 weeks during night time will improve spontaneous vaginal delivery among nulliparas. |
| Ethics approval(s) | Approved 21/5/2019, Medical Research Ethics Committee of University Malaya Medical Centre (UMMC, Lembah Pantai, 59100, Kuala Lumpur, Malaysia; Tel: +60 (0)3 7949 3209; Email: umrec@um.edu.my), ref: MREC ID NO: 201936-7199 |
| Health condition(s) or problem(s) studied | Spontaneous vaginal delivery among nulliparas |
| Intervention | Nulliparas who are at 34 - 36 weeks who attend the antenatal clinic in UMMC will be approached regarding this study. A patient information sheet will be provided for those who fulfil the initial eligibility criteria. Those who agree to participate will be asked to provide written consent. Randomisation with the intention to treat with a specific intervention or placebo sham method will follow. They will be randomised into two groups, interventional group or placebo using a sham method, based on a randomisation sequence generated using random.org in a random block of 4 or 8 sequence, generated by an investigator not involved in the recruitment process. Randomisation is by the opening of a sealed opaque and numbered envelope with lowest available envelope assigned in strict order. Interventional Group: Participants are provided with eye masks and earplugs to wear when they go to bed at night up till the delivery. They may remove the eye masks and earplugs temporarily if they wake up from sleep at night. At the end of 2 weeks, participants will receive a call from the investigator regarding sleep quality using a sleep questionnaire. They will be followed up until the delivery to analyse the spontaneous vaginal delivery as that is the primary objective. Placebo Group: Participants are provided with an elasticated headband to wear when they go to bed at night up until the delivery. The headband shall be placed on their forehead loosely. At the end of 2 weeks, participants will receive a call from the investigator regarding their sleep quality using a sleep questionnaire. They will be followed up until the delivery to analyse the spontaneous vaginal delivery as that is the primary objective. Patients' labour and neonatal outcomes will be collected after they deliver. |
| Intervention type | Other |
| Primary outcome measure | Spontaneous vaginal delivery assessed using questionnaire in the data collection form upon delivery |
| Secondary outcome measures | Night sleep assessed using questionnaire form after 2 weeks |
| Overall study start date | 01/11/2018 |
| Completion date | 30/07/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 234 |
| Total final enrolment | 234 |
| Key inclusion criteria | 1. Nulliparous (no prior pregnancy ≥ 20 weeks) 2. 34-36 weeks of gestation 3. Self-reported sleep less than 6 hours 4. Singleton pregnancy 5. Access to the phone |
| Key exclusion criteria | 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 disease 4. Planned caesarean delivery (e.g. placenta praevia , breech, maternal request) 5. Night shift workers or night care commitments 6. Active smoker 7. Current alcohol consumption 8. Maternal obesity >class II (BMI>35) 9. Intrauterine death 10. Care taker of other family members 11. Gross fetal anomaly |
| Date of first enrolment | 16/12/2019 |
| Date of final enrolment | 16/06/2020 |
Locations
Countries of recruitment
- Malaysia
Study participating centre
Kuala LLumpur
50603
Malaysia
Sponsor information
Hospital/treatment centre
Department of Obstetrics & Gynaecology
Jalan University
Lembah Pantai
Kuala Lumpur
50603
Malaysia
| Phone | +60 (0)6 79492077 |
|---|---|
| fomadmin@um.edu.my | |
"ROR" |
https://ror.org/00vkrxq08 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/06/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version V2 | 04/12/2017 | 11/06/2019 | No | No |
| Results article | 24/05/2023 | 25/05/2023 | Yes | No |
Additional files
- ISRCTN99834087_PROTOCOL_V2_04Dec17.docx
- Uploaded 11/06/2019
Editorial Notes
25/05/2023: Publication reference and total final enrolment added.
25/01/2021: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/06/2019 to 16/12/2019.
2. The recruitment end date was changed from 30/11/2019 to 16/06/2020.
3. The overall trial end date was changed from 01/03/2020 to 30/07/2020.
4. The intention to publish date was changed from 01/12/2020 to 01/06/2021.
11/06/2019: Uploaded protocol Version 2, 04 December 2017 (not peer reviewed).
04/06/2019: Trial's existence confirmed by research ethics committee.
