Depression, Post-PartumNCT06539858
Investigation of the Effect of Massage Application on Functional Status and Depression in Postpartum Mothers
An observational study of Depression, Post-Partum and Massage, run by University of Yalova at 1 site in Turkey (Türkiye).
Trial summary
Postpartum depression is a condition with high morbidity in mothers and negatively affects all family relationships. It has been observed that depression in the mother at only 2 months of age negatively affects the relationship between the baby and the mother, and that mothers who are depressed and therefore their… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Depression, Post-Partum, Massage, Functional Status
- What is being tested?
- massage
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 May 2024to 30 Mar 2025
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Young mothers who had just given birth and met the inclusion criteria for the study
Who may be able to join
- Being within the first 6 months postpartum
Who cannot join
- Having a health condition that prevents lying face down (having stitches from a cesarean section, hypertension, etc.)
- Not being cooperative
- All conditions that contraindicate massage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effect of Massage Application on Functional Status and Depression in Mothers in the Early Postpartum Period
Postpartum depression is a condition with high morbidity in mothers and negatively affects all family relationships. It has been observed that depression in the mother at only 2 months of age negatively affects the relationship between the baby and the mother, and that mothers who are depressed and therefore their babies feel more negatively. Symptoms usually start to appear from the 2nd or 3rd week after birth. At the same time, most people focus on the physical characteristics of the mother after birth, such as her reproductive system, while ignoring her full functionality. Full functionality is a multidimensional concept that includes personal care, baby care, family care, social and professional activities. In the first weeks after discharge, the functional status of the mother may differ as a result of the roles she assumes at home. Since the breastfeeding period will begin in new mothers, different treatment methods are preferred instead of drug treatment, one of which is massage therapy. It is thought that massage therapy relaxes the muscles and changes psychological factors. Previous studies conducted on postpartum women show that massage has a positive and healing effect on mothers. While previous studies frequently mention its effects on depression, it has also been observed that there are few studies mentioning its functional status. In light of this information, the aim of this study is to investigate the effects of massage on functional status and depression in postpartum women. For this purpose, there will be 2 groups randomized as intervention and control groups. The intervention will be performed as a 45-minute massage once a week for 4 weeks. Data will be collected before the first intervention and after the last intervention.
- Conditions
- Depression, Post-Partum, Massage, Functional Status
- Being tested
- massage
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
massageOther
General back massage from the base of the neck to the sacrum. Classical massage techniques such as stroking and kneeding will be applied. To be performed by a specialist physiotherapist.
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | This group will receive massage once a week for 4 weeks. Receives: Other: massage | |
| non-intervention group | No intervention will be made to this group |
What is being measured
The primary outcome is the main question the study is designed to answer.
depression
will be evaluated with the internationally accepted Edinburgh Postpartum Depression Scale. the name of the scale we use Edinburgh Postpartum Depression Scale. As the score obtained from this scale increases, the person's depression level also increases.
Measured: 4 weeks
functionality
The change in functionality will be evaluated using the postpartum functional status inventory. Inventory of Functional Status After Childbirth Turkish was used. According to this scale, a decrease in the score indicates that the functional status also decreases.
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 posted6 Aug 2024
- Study start10 May 2024
- Primary completion30 Aug 2024
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, Post-PartumStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Yalova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZEYNEP İCLAL SAG, University of Yalova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06539858
- Sponsor's protocol ID
- 2024/3
- Status last verified
- Dec 2025
- First submitted
- 1 Aug 2024
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Massage Application on Functional Status and Depression in Mothers in the Early Postpartum Period
- ClinicalTrials.gov ID
- NCT06539858
- Acronym / sponsor ID
- 2024/3
- Conditions
- Depression, Post-Partum, Massage, Functional Status
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of YalovaUniversity, hospital or other
- Study start
- 10 May 2024 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 6 Aug 2024 (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.
Postpartum depression is a condition with high morbidity in mothers and negatively affects all family relationships. It has been observed that depression in the mother at only 2 months of age negatively affects the relationship between the baby and the mother, and that mothers who are depressed and therefore their babies feel more negatively. Symptoms usually start to appear from the 2nd or 3rd week after birth. At the same time, most people focus on the physical characteristics of the mother after birth, such as her reproductive system, while ignoring her full functionality. Full functionality is a multidimensional concept that includes personal care, baby care, family care, social and professional activities. In the first weeks after discharge, the functional status of the mother may differ as a result of the roles she assumes at home. Since the breastfeeding period will begin in new mothers, different treatment methods are preferred instead of drug treatment, one of which is massage therapy. It is thought that massage therapy relaxes the muscles and changes psychological factors. Previous studies conducted on postpartum women show that massage has a positive and healing effect on mothers. While previous studies frequently mention its effects on depression, it has also been observed that there are few studies mentioning its functional status. In light of this information, the aim of this study is to investigate the effects of massage on functional status and depression in postpartum women. For this purpose, there will be 2 groups randomized as intervention and control groups. The intervention will be performed as a 45-minute massage once a week for 4 weeks. Data will be collected before the first intervention and after the last intervention.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional group | – | Other: massageThis group will receive massage once a week for 4 weeks. |
| non-intervention group | – | –No intervention will be made to this group |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Young mothers who had just given birth and met the inclusion criteria for the study
Key inclusion criteria (1 listed)
- Being within the first 6 months postpartum
Key exclusion criteria (3 listed)
- Having a health condition that prevents lying face down (having stitches from a cesarean section, hypertension, etc.)
- Not being cooperative
- All conditions that contraindicate massage
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 |
|---|---|---|
| massageGeneral back massage from the base of the neck to the sacrum. Classical massage techniques such as stroking and kneeding will be applied. To be performed by a specialist physiotherapist. | Other | Interventional group |
Primary outcome
depression
Time frame: 4 weeks
will be evaluated with the internationally accepted Edinburgh Postpartum Depression Scale. the name of the scale we use Edinburgh Postpartum Depression Scale. As the score obtained from this scale increases, the person's depression level also increases.
functionality
Time frame: 4 weeks
The change in functionality will be evaluated using the postpartum functional status inventory. Inventory of Functional Status After Childbirth Turkish was used. According to this scale, a decrease in the score indicates that the functional status also decreases.
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 19 Dec 2025.
- Individual participant dataSharing planned: No
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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 Depression, Post-Partum and Massage, 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 1 inclusion and 3 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 19 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?
depression (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 19 Dec 2025.