NCT07305545

Brief Summary

As the role of mothers increases in the postpartum period, depression, stress, sleep problems and general needs also increase. Recent studies have emphasized the need to treat more than just the mother's depression in cases of postpartum depression. The increase in the bond with the baby during this process is possible with the mother's compliance with the process. A healthy sleep between the mother and the baby improves the bond between them. One of the most important aids that facilitates the meeting of this need is baby massage. Baby massage is a tradition that begins immediately after birth in many cultures. Massage has a great positive effect on mother-baby interaction, increases the baby's sleep quality, reduces crying, lowers bilirubin levels and encourages mother-baby interaction. The aim of this study is to examine the effect of baby massage therapy applied by a physiotherapist on the baby's sleep duration and mother-baby attachment and the relationship between sleep duration and mother-baby attachment. The hypothesis of the study is that massage applied to babies will increase the baby's sleep quality and strengthen the bond between mother and baby.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 30, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 12, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 26, 2025

Completed
Last Updated

December 26, 2025

Status Verified

December 1, 2025

Enrollment Period

4 months

First QC Date

December 12, 2025

Last Update Submit

December 12, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Brief Infant Sleep Questionnaire

    This questionnaire asks everything you need to know about baby sleep.

    4 weeks

  • mother infant attachment scale

    This scale is answered by the mother. It measures the mother's level of bonding with her baby.

    4 weeks

Study Arms (2)

Interventional group

Group to be applied baby massage

Other: massage

non-intervention group

Group not to be applied baby massage

Interventions

massageOTHER

Basic classical baby massage, which is also taught to physiotherapists as part of their training. Classical massage will be applied to the baby's entire body, including the face.

Interventional group

Eligibility Criteria

Age0 Days - 6 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Healthy babies, aged 0-6 months and born at term, whose parents' consent has been obtained will be included in the study.

You may qualify if:

  • to be born on time
  • to be between 0-6 months old

You may not qualify if:

  • Conditions contraindicated for massage
  • Termination of volunteering by guardian

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Yalova

Yalova, Center, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Massage

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research assisstant

Study Record Dates

First Submitted

December 12, 2025

First Posted

December 26, 2025

Study Start

March 30, 2024

Primary Completion

August 10, 2024

Study Completion

November 30, 2024

Last Updated

December 26, 2025

Record last verified: 2025-12

Locations