NCT07867054

Brief Summary

This study aims to evaluate the effects of different massage techniques applied to mothers and infants on breastfeeding parameters and mother-infant bonding during the postpartum period. The study will investigate whether infant massage applied by mothers, oxytocin massage applied to mothers by fathers, or the combination of both interventions improves breastfeeding outcomes and mother-infant bonding compared with standard postpartum care.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
9mo left

Started Nov 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 9, 2026

Completed
23 days until next milestone

Study Start

First participant enrolled

November 1, 2026

Expected
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

October 9, 2026

Status Verified

October 1, 2026

Enrollment Period

8 months

First QC Date

September 30, 2026

Last Update Submit

October 6, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Breastfeeding Quality

    Breastfeeding quality will be assessed using the Bristol Breastfeeding Assessment Tool. Changes in breastfeeding quality from baseline to post-test will be evaluated.

    Before hospital discharge (pre-test) and at 4 weeks postpartum (post-test)

  • Mother-infant bonding

    Mother-infant bonding will be assessed using the Mother-Infant Bonding Scale. Changes in mother-infant bonding from baseline to post-test will be evaluated.

    Before hospital discharge (pre-test) and at 4 weeks postpartum (post-test)

  • Breastfeeding self-efficacy

    Breastfeeding self-efficacy will be assessed using the Breastfeeding Self-Efficacy Scale. Changes in breastfeeding self-efficacy from baseline to post-test will be evaluated.

    Before hospital discharge (pre-test) and at 4 weeks postpartum (post-test)

Study Arms (4)

Control Group

NO INTERVENTION

Mothers and their infants in the control group will not receive any experimental intervention, including oxytocin massage or infant massage, from the researcher. They will continue to receive the hospital's standard routine postpartum care and breastfeeding counseling according to the institutional protocol. Assessments will be conducted before hospital discharge (pre-test) and at 4 weeks postpartum (post-test).

Infant Massage Group

EXPERIMENTAL

Mothers in this group will administer infant massage to their own infants once daily for four weeks, for approximately 15 minutes per session, in accordance with the standardized infant massage protocol described above.

Behavioral: Infant Massage

Oxytocin Massage Group

EXPERIMENTAL

Mothers in this group will receive oxytocin massage from their partners/their infants' fathers once daily for four weeks, in accordance with the standardized oxytocin massage protocol described above.

Behavioral: Oxytocin Massage

Infant Massage and Oxytocin Massage Group

EXPERIMENTAL

Both interventions will be administered in this group. Oxytocin massage will be administered by the father to the mother, while infant massage will be administered by the mother to the infant. Both interventions will be performed once daily for four weeks in accordance with the standardized intervention protocols described above.

Behavioral: Infant Massage and Oxytocin Massage

Interventions

Infant MassageBEHAVIORAL

Mothers will be trained by the researcher to administer standardized infant massage to their own infants. After supervised practice before hospital discharge, mothers will administer infant massage once daily for 4 weeks, for approximately 15 minutes per session. Massage will be performed according to the standardized protocol.

Infant Massage Group

Fathers will be trained by the researcher to administer standardized oxytocin massage to the mothers. After supervised practice before hospital discharge, fathers will administer oxytocin massage once daily for 4 weeks according to the standardized protocol. Each session will last approximately 15-20 minutes.

Oxytocin Massage Group

Mothers will administer standardized infant massage to their own infants, while fathers will administer standardized oxytocin massage to the mothers. Both interventions will be performed once daily for 4 weeks according to the standardized intervention protocols. Infant massage will last approximately 15 minutes, and oxytocin massage will last approximately 15-20 minutes per session.

Infant Massage and Oxytocin Massage Group

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Mother:
  • Being primiparous.
  • Being within the first 24 hours postpartum.
  • Having a singleton birth.
  • Rooming-in with her infant during the postpartum period.
  • Having no physical or mental health condition that would prevent breastfeeding or participation in the study.
  • Being willing to regularly administer infant massage to her infant for 4 weeks postpartum.
  • Having no health condition that would prevent the mother or infant from receiving massage.
  • Being able to speak Turkish and having no condition that would interfere with communication.
  • Father:
  • Being present with the mother during the postpartum period.
  • Being able to speak Turkish and having no condition that would interfere with communication.
  • Being able to regularly administer oxytocin massage to the mother for 4 weeks postpartum.
  • Infant:
  • Being born at term (37-42 weeks of gestation).
  • +1 more criteria

You may not qualify if:

  • The mother cannot be reached at 4 weeks postpartum.
  • Infant massage is performed fewer than twice per week.
  • Oxytocin massage is performed fewer than twice per week.
  • The infant is admitted to the neonatal intensive care unit.
  • The mother develops a postpartum complication (e.g., postpartum hemorrhage or suspected infection).
  • Participants assigned to the oxytocin massage group administer infant massage.
  • Participants assigned to the infant massage group administer oxytocin massage.
  • Participants assigned to the control group administer either oxytocin massage or infant massage.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Central Study Contacts

Özge Şen, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
This is an open-label study. Participants and individuals delivering the massage interventions will be aware of group assignment because the nature of the interventions does not allow masking. Data analysis will be performed by an independent statistician using groups coded as A, B, C, and D. The group codes will be revealed only after completion of the statistical analyses, and the results will then be interpreted.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to one of four parallel groups: (1) standard postpartum care (control group), (2) infant massage applied by the mother, (3) oxytocin back massage applied to the mother by the father, or (4) a combination of infant massage applied by the mother and oxytocin back massage applied to the mother by the father. Participants will remain in their assigned group throughout the study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate

Study Record Dates

First Submitted

September 30, 2026

First Posted

October 9, 2026

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

October 9, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

There is no plan to share individual participant-level data.