- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07305545
Investigation of the Effect of Massage Therapy on Sleep Duration and Mother-Baby Bonding in Newborn
December 12, 2025 updated by: GÖZDE ARICA, University of Yalova
Investigation of the Effect of Massage Therapy on Sleep Duration and Mother-Baby Bonding in 0-6 Month Term Infants
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
24
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Center
-
Yalova, Center, Turkey (Türkiye)
- University of Yalova
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Sampling Method
Probability 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.
Description
Inclusion Criteria:
- to be born on time
- to be between 0-6 months old
Exclusion Criteria:
- Conditions contraindicated for massage
- Termination of volunteering by guardian
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Interventional group
Group to be applied baby massage
|
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.
|
|
non-intervention group
Group not to be applied baby massage
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Brief Infant Sleep Questionnaire
Time Frame: 4 weeks
|
This questionnaire asks everything you need to know about baby sleep.
|
4 weeks
|
|
mother infant attachment scale
Time Frame: 4 weeks
|
This scale is answered by the mother.
It measures the mother's level of bonding with her baby.
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 30, 2024
Primary Completion (Actual)
August 10, 2024
Study Completion (Actual)
November 30, 2024
Study Registration Dates
First Submitted
December 12, 2025
First Submitted That Met QC Criteria
December 12, 2025
First Posted (Actual)
December 26, 2025
Study Record Updates
Last Update Posted (Actual)
December 26, 2025
Last Update Submitted That Met QC Criteria
December 12, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024/2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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