Mechanical massage using an electric massage chair and the onset of coming in of breastmilk in first-time mothers
| ISRCTN | ISRCTN16026114 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16026114 |
| Secondary identifying numbers | MREC ID NO: 2023713-12663 |
- Submission date
- 16/02/2024
- Registration date
- 19/02/2024
- Last edited
- 27/02/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English Summary
Background and study aims
Hand (manual) massage especially along the back and foot after birth has been shown to speed up the first coming in of breast milk and of milk production. Hand massage is time consuming and a learnt skill. The electric mechanical massage chair is reusable, simple to operate and consistent in the massage it delivers but it has not been explored if it is effective. Delayed or perceived inadequate milk production can cause problems with the start or maintenance of breastfeeding of the baby.
WHO and UNICEF recommend that infants be exclusively breastfed for the first 6 months of life.
First time mothers take a longer time to first breastfeeding attempt, are more likely to have eight or fewer feeding attempts in the first 24 hours, to report early breastfeeding problems, are mixed feeding at hospital discharge and less likely to breastfeed through 6 months.
This study aims to compare the effect of two massage programs of an electric massage chair to evaluate if they work on to hasten the onset of lactation (lactogenesis stage II).
Who can participate?
First time mothers aged 18-45 years, without any serious illness or chronic disease, with a straightforward vaginal delivery, a healthy baby and planning to breastfeed.
What does the study involve?
Participants will be randomised into 2 groups:
(1) The intervention group will be given a back massage program using the electric massage chair twice daily, for 20 minutes each session, starting from 3-6 hours postdelivery, until the day of discharge.
Or
(2) The control group will be given a calf massage program using the electric massage chair twice daily, for 20 minutes each session, starting from 3-6 hours postdelivery, until the day of discharge.
Follow up for 10 days post-delivery.
What are the possible benefits and risks of participating?
The allocated massage may hasten, have no effect or delay onset of lactation. The massages may increase relaxation or cause discomfort. Use of massage chair is not expected to cause major adverse consequences.
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?
January 2024 to December 2024
Who funds this study?
The Department of Obstetrics & Gynaecology, UMMC (Malaysia)
Who is the main contact person?
Dr Nurul Atiqah Binti Radzali, atiqah.radzali@ummc.edu.my
Dr Neha Sethi A/p Naresh Sethi, s_neha26@um.edu.my
Contact information
Public, Scientific, Principal Investigator
University Malaya Medical centre , Lembah Pantai
Kuala Lumpur
59100
Malaysia
| Phone | +60 177916694 |
|---|---|
| atiqah.radzali@ummc.edu.my |
Scientific
University Malaya Medical Centre, Lembah Pantai
Kuala Lumpur
59100
Malaysia
| Phone | +60 17-3702555 |
|---|---|
| s_neha26@um.edu.my |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life, Efficacy |
| Participant information sheet | 45056 PIS v1 22Oct2023.pdf |
| Scientific title | Mechanical Massage By An Electric Massage Chair on Lactogenesis Stage II (Onset of Lactation) In First-Time Mothers: A Randomised Controlled Trial |
| Study hypothesis | Mechanical back massage will hasten the onset of lactation (lactogenesis stage II) in first-time mothers after a vaginal delivery |
| Ethics approval(s) |
Approved 06/02/2024, Medical Research Ethics Committee University Of Malaya Medical Centre (Lembah Pantai , Kuala Lumpur, Kuala Lumpur, 59100, Malaysia; +60 03-79493209; ummc-mrec@ummc.edu.my), ref: MREC ID NO: 2023713-12663 |
| Condition | Onset of lactation in first time mothers |
| Intervention | Participants after written informed consenting will be randomised into two groups: 1. The intervention group will be given a back massage program using the electric massage chair twice daily, for 20 minutes each session, starting from 3-6 hours postdelivery, until the day of discharge. Or 2. The control group will be given a calf massage program using the electric massage chair twice daily, for 20 minutes each session, starting from 3-6 hours postdelivery, until the day of discharge. Randomisation sequence will be generated separately using an online generator (https://www.sealedenvelope.com/simple-randomiser/v1/lists), in 1 to 1 ratio and random blocks of 4 or 8, by a co-investigator who will not be involved in the recruitment process. Randomisation will be implemented using strict sequential assignment of the lowest-numbered remaining sealed envelope to the newest recruit. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Mechanical Electric Massage Chair |
| Primary outcome measure | 1. Time from birth to onset of lactation (lactogenesis stage II) [As reported by the mother on daily assessment] Breast fullness is rated on a 5-point scale: from 1 (no change) to 3 (noticeably full) to 5 (uncomfortably full). Onset of lactation is defined as the first breast fullness score of 3 or greater as reported by the mother. |
| Secondary outcome measures | 1. Maternal satisfaction with their assigned mechanical massage chair experience using a 11 point (0-10) numerical rating scale prior to discharge. [As reported by the mother] 2. Baby's breastfeeding performance using Infant Breastfeeding Assessment Tool (IBFAT) prior to discharge. [As reported by the mother] 3. Baby's breastfeeding performance using Infant Breastfeeding Assessment Tool (IBFAT) at Day 10 after birth. [As reported by the mother] 4. Exclusive breastfeeding at Day 10 after birth. [As reported by the mother] IBFAT score of 10–12 indicates successful breastfeeding, a score of 7–9 relatively successful breastfeeding and a score of 0–6 unsuccessful breastfeeding. |
| Overall study start date | 01/01/2024 |
| Overall study end date | 30/12/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 45 Years |
| Sex | Female |
| Target number of participants | 234 |
| Participant inclusion criteria | 1. Primiparous 2. Spontaneous vaginal deliveries mother without complications 3. 18 - 45 years 4. Singleton pregnancy 5. Term pregnancy > 37 weeks 6. Birth weight > 2500g 7. No serious illness/chronic disease 8. Ability to read and write, acceptable ability of listening and speaking to answer the questions 9. Intention to breastfeed 10. Can communicate in Malay or English |
| Participant exclusion criteria | 1. Contraindication to breastfeeding 2. Postpartum complication e.g., haemorrhage, chorioamnionitis, retained placenta, any invasive procedures and blood transfusion 3. Newborns with complications |
| Recruitment start date | 01/04/2024 |
| Recruitment end date | 31/10/2024 |
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 03-79494422. |
|---|---|
| ummc@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 | 30/06/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | This research will be presented and published in the Clinical Masters final thesis, and published in a high impact scientific journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Nurul Atiqah Radzali (atiqah.radzali@ummc.edu.my) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1 | 22/10/2023 | 19/02/2024 | No | Yes |
| Protocol file | version 1 | 22/10/2023 | 19/02/2024 | No | No |
| Participant information sheet | version 2.0 | 24/02/2024 | 27/02/2024 | No | Yes |
| Protocol file | version 2.0 | 24/02/2024 | 27/02/2024 | No | No |
Additional files
Editorial Notes
27/02/2024: Patient information sheet version 2 and protocol version 2 (not peer reviewed) were uploaded.
19/02/2024: Trial's existence confirmed by Medical Research Ethics Committee University Of Malaya Medical Centre
