MassageNCT07305545
Investigation of the Effect of Massage Therapy on Sleep Duration and Mother-Baby Bonding in Newborn
An observational study of Massage and Sleep, run by University of Yalova at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 0 days to 6 monthsHealthy volunteers can take part
- What is being tested?
- massage
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Mar 2024to 30 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy babies, aged 0-6 months and born at term, whose parents' consent has been obtained will be included in the study.
Who may be able to join
- to be born on time
- to be between 0-6 months old
Who cannot join
- Conditions contraindicated for massage
- Termination of volunteering by guardian
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- massage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Group to be applied baby massage Receives: Other: massage | |
| non-intervention group | Group not to be applied baby massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Infant Sleep Questionnaire
This questionnaire asks everything you need to know about baby sleep.
Measured: 4 weeks
mother infant attachment scale
This scale is answered by the mother. It measures the mother's level of bonding with her baby.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start30 Mar 2024
- Primary completion10 Aug 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MassageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Yalova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GÖZDE ARICA, University of Yalova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07305545
- Sponsor's protocol ID
- 2024/2
- Status last verified
- Dec 2025
- First submitted
- 12 Dec 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Massage Therapy on Sleep Duration and Mother-Baby Bonding in 0-6 Month Term Infants
- ClinicalTrials.gov ID
- NCT07305545
- Acronym / sponsor ID
- 2024/2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of YalovaUniversity, hospital or other
- Study start
- 30 Mar 2024 (actual)
- Primary completion
- 10 Aug 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 26 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional group | – | Other: massageGroup to be applied baby massage |
| non-intervention group | – | –Group not to be applied baby massage |
Who may qualify
- Ages
- 0 days to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy babies, aged 0-6 months and born at term, whose parents' consent has been obtained will be included in the study.
Key inclusion criteria (2 listed)
- to be born on time
- to be between 0-6 months old
Key exclusion criteria (2 listed)
- Conditions contraindicated for massage
- Termination of volunteering by guardian
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| massageBasic 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. | Other | Interventional group |
Primary outcome
Brief Infant Sleep Questionnaire
Time frame: 4 weeks
This questionnaire asks everything you need to know about baby sleep.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Massage and Sleep, run by University of Yalova at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Infant Sleep Questionnaire (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.