Pain relief for the first stage of labour using an electric massage chair
| ISRCTN | ISRCTN78483098 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78483098 |
| Secondary identifying numbers | 2.0 |
- Submission date
- 04/07/2022
- Registration date
- 03/08/2022
- Last edited
- 13/11/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
Labour is typically painful, especially during the first labour. Many women require pain relief in labour. Epidural, opiate-type drugs and inhaling gas and air are commonly offered forms of pain relief. These methods have potential undesired effects on the mother and her baby. Massage by a human therapist is an effective pain-relieving technique during labour. However, trained massage therapists are not available in the usual labour ward setting, the service is labour intensive and likely costly.
We plan to evaluate the use of a commercially available electric massage chair capable of providing a full body massage on its pain-relieving potential during the labour of women expecting their first baby as proof of the concept of mechanical massaging being effective.
Who can participate?
Women who have not had a previous pregnancy beyond 20 weeks (nulliparous), who are at full term, and who were admitted to the labour ward in the first stage of labour
What does the study involve?
Participants in one group will receive 30 minutes on a commercially procured electric massage chair that provides a full body massage program with the massaging function switched on and then 30 minutes with the massaging function switched off. Participants in a second group will do the opposite and receive 30 minutes on the electric massage chair with the massaging function switched off and then 30 minutes with the massaging function switched on. The groups will be compared using a Visual Numerical Rating Scale (VNRS) and questionnaire to score perceived pain.
What are the possible benefits and risks of participating?
There is no significant benefit or risk anticipated as all participants are exposed to the massage chair as this trial has a cross-over design. The massage provided by the chair may or may not be effective in providing pain relief. No significant harm is anticipated from the intervention with the massage chair as routine labour monitoring and care are continued during the massage.
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?
January 2022 to March 2023
Who is funding the study?
Universiti Malaya (Malaysia)
Who is the main contact?
Nadia Mazia (Malaysia)
maziatunk@ummc.edu.my
Contact information
Scientific
University Malaya Medical Centre (UMMC)
Lembah Pantai
Kuala Lumpur
59100
Malaysia
| Phone | +60 (0)13-2677656 |
|---|---|
| maziatunk@ummc.edu.my |
Principal Investigator
University Malaya Medical Centre (UMMC)
Lembah Pantai
Kuala Lumpur
59100
Malaysia
 ORCID ID |
0000-0001-8713-6581 |
|---|---|
| Phone | +60 3 7841 4000 |
| pctan@um.edu.my |
Study information
| Study design | Randomized cross-over trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format |
| Scientific title | Massage chair as pain relief in the first stage of labour in nulliparas: A randomised cross-over trial (MASPAR) |
| Study acronym | MASPAR |
| Study objectives | The objective of this proposed study is to evaluate the effect of massage chair therapy on labour pain |
| Ethics approval(s) | Approved 13/6/2022, Medical Research Ethics Committee of The University of Malaya Medical Centre (Lembah Pantai, 59100 Kuala Lumpur, Malaysia; +60 (0)3-79493209; iresearch@ummc.edu.my), ref: 2022323-11097 |
| Health condition(s) or problem(s) studied | Pain relief in labour |
| Intervention | Nulliparous women at term in the first stage of labour will be randomised to 30 minutes on the electric massage chair with the massaging function switched on then cross over to 30 minutes with the massaging function switched off or 30 minutes on the electric massage chair with the massaging function switched off then cross over to 30 minutes with the massaging function switched on. A commercially procured electric massage chair that provides a full body massage program will be used. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Electric massage chair |
| Primary outcome measure | Pain score (0 to 10 numerical rating scale) measured using an 11-point visual numerical rating scale (VNRS) (0 scoring as no pain at all to 10 as the worst pain imaginable) immediately after each 30-minute session on the massage chair with the massage function switched on or off |
| Secondary outcome measures | Maternal outcomes: 1. Mode of delivery measured by reviewing patient’s notes after delivery 2. Intervention to delivery interval measured by reviewing patient’s notes after delivery 3. Epidural anaesthesia in labour measured by reviewing patient’s notes after delivery 4. Likert scale response to the questionnaire on pain relieving effectiveness of the massage by the massage chair after delivery Neonatal outcomes: 4. Umbilical cord arterial pH measured by reviewing patient’s notes at birth 5. Apgar score at 1 and 5 minutes measured by reviewing patient’s notes at birth 6. Neonatal admission measured by reviewing patient’s notes at birth |
| Overall study start date | 07/01/2022 |
| Completion date | 02/03/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 200 |
| Key inclusion criteria | 1. Nulliparous (no previous pregnancy beyond 20 weeks) 2. Aged 18 years old and over 3. 37 weeks gestation and over 4. Singleton pregnancy 5. Cephalic presentation 6. Reassuring cardiotocogram in last 1 hour 7. Cervical dilation 4-8 cm 8. Contraction ≥ 3 in 10 minutes 9. Pain score ≥ 5 (0-10 NRS) |
| Key exclusion criteria | 1. High-risk pregnancies (pre-eclampsia, active hemorrhage) 2. No prior pain relief (epidural, opiates, nitrous oxide or pain relief device) 3. Meconium-stained liquor 4. Oxytocin dose adjustment in the last hour 5. Bladder catheter in place 6. Delivery anticipated within the next 2 hours |
| Date of first enrolment | 04/08/2022 |
| Date of final enrolment | 23/02/2023 |
Locations
Countries of recruitment
- Malaysia
Study participating centre
Kuala Lumpur
59100
Malaysia
Sponsor information
Hospital/treatment centre
Lembah Pantai
Kuala Lumpur
59100
Malaysia
| Phone | +60 (0)3 79493209 |
|---|---|
| iresearch@ummc.edu.my | |
| Website | http://www.ummc.edu.my |
"ROR" |
https://ror.org/00vkrxq08 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Malaya, University Malaya, Malayan University, UM
- Location
- Malaysia
Results and Publications
| Intention to publish date | 01/01/2024 |
|---|---|
| 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 |
Editorial Notes
13/11/2023: The following changes were made:
1. The recruitment start date was changed from 01/09/2022 to 04/08/2022.
2. The recruitment end date was changed from 31/07/2023 to 23/02/2023.
3. Overall study end date was changed from 07/08/2023 to 02/03/2023.
29/07/2022: Trial's existence confirmed by the Medical Research Ethics Committee of The University of Malaya Medical Centre.
