Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001325392
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
3/03/2026
Date registered
Help: Date registered
3/11/2026
Date last updated
Help: Date last updated
3/11/2026
Date data sharing statement initially provided
Help: Data sharing statement date
3/11/2026
Date results provided
Help: Date results provided
3/11/2026
Type of registration
Help: Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of Oxytocin Massage and Slow Back Massage on Breast Milk Production and Prevention of Early Stunting in Postpartum Mothers: A Randomized Controlled Trial
Scientific title
Effect of Oxytocin Massage and Slow Back Massage on Breast Milk Production and Prevention of Early Stunting in Postpartum Mothers: A Randomized Controlled Trial
Additional trial identifiers [1] 316662 0
Nil known
Universal Trial Number (UTN)
U1111-1336-4229
Trial acronym
Slow-Stroke Back Massage (SSBM)
Related trial records

Health condition
Health condition(s) studied:
Breast feeding 340889 0
Condition category
Condition code
Reproductive Health and Childbirth 337048 337048 0 0
Breast feeding

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The intervention in this study was a combination of oxytocin massage and Slow-Stroke Back Massage (SSBM) for postpartum mothers to increase breast milk production.
Massage interventions in intervention groups 1 and 2 were performed twice during the patients' hospital stay. The first massage was performed on the first day postpartum, and the second on the third day, the day the mothers were discharged. Family members were encouraged to attend the massage sessions so they could learn techniques they could apply at home. Patients in both intervention groups 1 and 2 continued to perform massage independently at home. Researchers followed up on the massage sessions via phone/WhatsApp during the first and second weeks.
The oxytocin massage technique is performed in the following steps:
1) Prepare the equipment, wash your hands, greet the client, introduce yourself, and explain the procedure and purpose of the procedure to the client/family.
2) The mother sits or leans back in a chair with her back straight. She can also hug a pillow to support her front, if needed. Ensure the area of her back to be massaged is open and easily accessible.
3) Use massage oil (baby oil or lavender essential oil) to facilitate smooth movement.
4) Massage both sides of the spine, starting from the neck to the shoulder blades.
5) Use your thumbs or fists to massage in circular motions and apply gentle pressure. You can also massage up and down from the neck down to the shoulder blades.
6) Massage each side of the spine for 2-3 minutes.
7) Gently massage until the mother feels relaxed.
8) After the massage, you can repeat the massage several times if needed. Cleanse the back area with a warm washcloth. Make sure you are comfortable after the massage.
9) Repeat each step about 5-10 times, with a total duration of 15-20 minutes

The SSBM massage procedure is carried out as follows:
1) Prepare the equipment, wash your hands, greet the client, introduce yourself, and explain the procedure and purpose of the procedure to the client/family.
2) Position the mother comfortably and calmly. Massage the upper neck with small circular movements using both thumbs.
3) Alternately stroke with one hand from the base of the neck, down the spine, to the waist.
4) Stroke with your thumbs from below the ears down the neck to the collarbone, just above the shoulder blades.
5) Place the thumbs of each hand next to the spine, starting at the shoulders and moving down the spine to the waist.
6) Finally, place your palms on each side of the mother's neck and make continuous, long, sweeping strokes down the neck, across each shoulder, and back down to the spine.
7) Repeat each step about 5-7 times for a total duration of 15-20 minutes

All interventions were administered by trained nurses competent in performing oxytocin massage and SSBM

Participants were advised to perform oxytocin massage and SSBM once daily after personal hygiene activities in the morning

In group 2, SSBM was performed immediately after the completion of the oxytocin massage

Nurses reported regularly to the research team’s WhatsApp communication group each time an intervention was administered. Subsequently, the researchers audited the integrated patient progress notes to ensure adherence to the intervention procedures.
Intervention code [1] 333339 0
Treatment: Other
Description of the comparator or control
The control group did not receive oxytocin massage or SSBM from the research team. The control group received standard routine hospital procedures, including monitoring of uterine involution and breast care for milk expression, which were also documented in the integrated patient care records.
Control group
Active

Outcomes
Primary outcome [1] 344561 0
The study outcome was a change in breast milk production measured before and after the intervention among intervention group 1, intervention group 2, and the control group.
Timepoint [1] 344561 0
The post-test or evaluation will be assessed twice: on the 30th day postpartum and the 60th day postpartum.
Secondary outcome [1] 458342 0
Change in infant height-for-age between pretest and posttest among intervention group 1, intervention group 2, and the control group.
Timepoint [1] 458342 0
The post-test or evaluation will be assessed twice: on the 30th day postpartum and the 60th day postpartum.

Eligibility
Key inclusion criteria
Inclusion criteria included postpartum mothers with healthy babies born vaginally or by Caesarean section, who signed an informed consent, and who resided in Banda Aceh and Aceh Besar district.
Minimum age
19 Years
Maximum age
59 Years
Sex
Females
Healthy volunteers
No
Key exclusion criteria
Exclusion criteria included postpartum mothers with mental disorders and those with babies with disabilities or illnesses.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The respondent randomization process is carried out by drawing lots with numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using procedures coin-tossing
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The entire population was randomized into three groups: two intervention groups and one control group. Although this number is lower than the ideal sample size based on power calculations (246 participants), the finite population correction (FPC) estimated approximately 70 participants. This approach still ensures sufficient power to identify moderate differences between groups. The Finite Population Correction (FPC) is used in sample size determination when the total population (N) is relatively small (typically less than 10,000) and sampling is without replacement. It reduces the required sample size because, in small populations, a smaller sample can still be representative. Consequently, the adjusted total sample size is approximately 70–75 participants. The sample size, calculated using the FPC, was estimated at approximately 75. The 75 participants split into 3 groups of postpartum mothers. The first group received oxytocin massage; the second group received both oxytocin massage and the SSBM intervention; and the third group, the control group, received only routine hospital care.

Analysis was performed in frequency distribution, and with STATA 13, using McNemar's Exact Binomial test to examine changes in breastfeeding adequacy across pre-test, post-test 1, and post-test 2. Z-score differences for stunting were analyzed using a paired T-test and a Wilcoxon signed-rank test. Results are summarized in tables and descriptive statistics

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/08/2025
Date of last participant enrolment
Anticipated
Actual
13/09/2025
Date of last data collection
Anticipated
Actual
15/11/2025
Sample size
Target
75
Accrual to date
Final
75
Recruitment outside Australia
Country [1] 27866 0
Indonesia
State/province [1] 27866 0
Aceh

Funding & Sponsors
Funding source category [1] 321275 0
University
Name [1] 321275 0
Universitas Syiah Kuala
Country [1] 321275 0
Indonesia
Primary sponsor type
University
Name
Universitas Syiah Kuala
Address
Country
Indonesia
Secondary sponsor category [1] 323986 0
Hospital
Name [1] 323986 0
Zainoel Abidin General Hospital, Aceh
Address [1] 323986 0
Country [1] 323986 0
Indonesia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319804 0
The Health Research Ethics Committee at Zainoel Abidin General Hospital, Aceh
Ethics committee address [1] 319804 0
Ethics committee country [1] 319804 0
Indonesia
Date submitted for ethics approval [1] 319804 0
15/07/2025
Approval date [1] 319804 0
14/08/2025
Ethics approval number [1] 319804 0
267/ETIK-RSUDZA/2025

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 148454 0
Dr Darmawati Darmawati
Address 148454 0
Faculty of Nursing, Syiah Kuala University, Darussalam-Banda Aceh, Indonesia, 23111.
Country 148454 0
Indonesia
Phone 148454 0
+62895320275915
Fax 148454 0
Email 148454 0
[email protected]
Contact person for public queries
Name 148455 0
Darmawati Darmawati
Address 148455 0
Faculty of Nursing, Syiah Kuala University, Darussalam-Banda Aceh, Indonesia, 23111.
Country 148455 0
Indonesia
Phone 148455 0
+62895320275915
Fax 148455 0
Email 148455 0
[email protected]
Contact person for scientific queries
Name 148456 0
Darmawati Darmawati
Address 148456 0
Faculty of Nursing, Syiah Kuala University, Darussalam-Banda Aceh, Indonesia, 23111.
Country 148456 0
Indonesia
Phone 148456 0
+62895320275915
Fax 148456 0
Email 148456 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: The study not consider sharing individual participant data




What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    Ethical Aprpoval 1. ethical-approval.pdf
Informed consent form    Study Explanation and informed consent Study explanation and IC.pdf
Other    Intervention Procedures Intervention procedures_fix.pdf


Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsYes Study Result Article (1).pdf

Documents added automatically
No additional documents have been identified.