Depression, PostpartumNCT05813782
The Effect of Baby Massage on Postpartum Depression and Maternal Attachment
A study testing Baby Massage in people with Depression, Postpartum and Maternal Behavior, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to determine the effect of baby massage on postpartum depression and maternal attachment in the postpartum period. Read more about this study
- Who is it for?
- Ages 19 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Depression, Postpartum, Maternal Behavior, Attachment
- What is being tested?
- Baby Massage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Sep 2022to 15 Aug 2023
- Phase
- Interventional
- 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 19 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Primiparous,
- Cesarean section,
- Having a single baby,
- Between the ages of 19-35,
- Literate
- Effective communication.
Who cannot join
- Having a premature baby,
- Mother and baby have a disease that prevents massage,
- Loss of vision and hearing.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Tokat Gaziosmanpaşa University
Tokat Province, 60250
Ayla KORKMAZ, asst. prof., ayla.korkmaz@gop.edu.tr
Ayla KORKMAZ, asst. prof.
About this study
Official title: The Effect of Baby Massage on Postpartum Depression and Maternal Attachment in the Postpartum Period: A Randomized Controlled Study
This study was conducted to determine the effect of baby massage on postpartum depression and maternal attachment in the postpartum period.
Read the detailed description
The transition to motherhood is one of the life stages that brings about stress and change. Primiparous mothers, who will experience motherhood for the first time due to anxiety about the unknown, may experience more stress and their communication with their babies may deteriorate. In this process, the mother's seeing, touching and interacting with her baby positively affects her perception of her baby. The easiest and most natural way to do this is baby massage. Touching and massaging the baby maintains the baby's body contact, which strengthens the baby's sense of trust and supports the mother's development of attachment behavior. It also reduces mothers' levels of stress hormones such as cortisol and relieves depressive symptoms.
- Conditions
- Depression, Postpartum, Maternal Behavior, Attachment
- Being tested
- Baby Massage
- Keywords
- Primiparous mother, Baby massage, Postpartum depression, Maternal attachment
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baby MassageBehavioural
Baby massage training (30 minutes) was given to primiparous mothers before they were discharged from the hospital. Baby massage training consists of sections that explain the importance of massage, preparation for massage, stages of baby massage and situations that need attention. Primiparous mothers were told to do this massage to their babies in the postpartum period. Baby massage video CD, brochure and baby oil were given to primiparous mothers for an effective baby massage.
| Study group | Role | What they receive |
|---|---|---|
| No intervention arms | No intervention | Primiparous mothers in this group answered the postpartum depression scale (pre-test) before discharge from the hospital. No intervention was made in addition to routine postnatal care. Primiparous mothers answered the maternal attachment scale and the postpartum depression scale (post-test) on postpartum 42nd day. |
| Experimental arms | Experimental | Primiparous mothers in the experimental group answered the postpartum depression scale before baby massage training. Afterwards, baby massage training (30 min.) was given. Baby model, baby massage video CD and brochure were used in the training. Primiparous mothers were told to apply baby massage regularly for 15 minutes, once a day, every day from the 5th to 42nd day after birth. An "Baby Massage Follow-up Form" was given to primiparous mothers to record the days of massage. Baby massage application order was provided by phone calls twice a week. Primiparous mothers answered the maternal attachment scale and the postpartum depression scale (post-test) on postpartum 42nd day. Receives: Behavioral: Baby Massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpartum depression
The Edinburgh postpartum depression scale (EPDS) was used to determine the level of postpartum depression. EPDS is a 4-point Likert-type scale consisting of 10 questions and is scored between 0-3. The total score of the scale is obtained by summing the item scores. People with a score above 12 points are considered a risk group. The lowest score is 0 and the highest score is 30.
Primiparous mothers answered before training (pretest) and postpartum 42nd day (posttest).
Measured: Postpartum 42nd day
Maternal attachment
The level of maternal attachment was assessed using the " The Maternal Attachment Inventory (MAI)". The inventory consists of 26 Likert type items. Each item is scored between 1 and 4. Therefore, the minimum score of the inventory is 26 and the maximum score is 104. A high score indicates high attachment to the mother.
Primiparous mothers answered on postpartum 42nd day (posttest).
Measured: Postpartum 42nd day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start3 Sep 2022
- Primary completion15 May 2023 (estimated)
- Study completion15 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, PostpartumStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Collaborators
- TC Erciyes University
- Responsible party
- Principal investigator, Ayla KORKMAZ, Tokat Gaziosmanpasa University
- Investigators
- Ayla KORKMAZ, asst. prof., Principal investigator, Tokat Gaziosmanpaşa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05813782
- Sponsor's protocol ID
- 22-KAEK-084
- Status last verified
- Apr 2023
- First submitted
- 23 Mar 2023
- Last updated
- 14 Apr 2023
- 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 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Baby Massage on Postpartum Depression and Maternal Attachment in the Postpartum Period: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05813782
- Acronym / sponsor ID
- 22-KAEK-084
- Conditions
- Depression, Postpartum, Maternal Behavior, Attachment
- Keywords
- Primiparous mother, Baby massage, Postpartum depression, Maternal attachment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Collaborators
- TC Erciyes University
- Study start
- 3 Sep 2022 (actual)
- Primary completion
- 15 May 2023 (estimated)
- Study completion
- 15 Aug 2023 (estimated)
- First posted
- 14 Apr 2023 (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.
This study was conducted to determine the effect of baby massage on postpartum depression and maternal attachment in the postpartum period.
Detailed description
The transition to motherhood is one of the life stages that brings about stress and change. Primiparous mothers, who will experience motherhood for the first time due to anxiety about the unknown, may experience more stress and their communication with their babies may deteriorate. In this process, the mother's seeing, touching and interacting with her baby positively affects her perception of her baby. The easiest and most natural way to do this is baby massage. Touching and massaging the baby maintains the baby's body contact, which strengthens the baby's sense of trust and supports the mother's development of attachment behavior. It also reduces mothers' levels of stress hormones such as cortisol and relieves depressive symptoms.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No intervention arms | No intervention | –Primiparous mothers in this group answered the postpartum depression scale (pre-test) before discharge from the hospital. No intervention was made in addition to routine postnatal care. Primiparous mothers answered the maternal attachment scale and the postpartum depression scale (post-test) on postpartum 42nd day. |
| Experimental arms | Experimental | Behavioral: Baby MassagePrimiparous mothers in the experimental group answered the postpartum depression scale before baby massage training. Afterwards, baby massage training (30 min.) was given. Baby model, baby massage video CD and brochure were used in the training. Primiparous mothers were told to apply baby massage regularly for 15 minutes, once a day, every day from the 5th to 42nd day after birth. An "Baby Massage Follow-up Form" was given to primiparous mothers to record the days of massage. Baby massage application order was provided by phone calls twice a week. Primiparous mothers answered the maternal attachment scale and the postpartum depression scale (post-test) on postpartum 42nd day. |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Primiparous,
- Cesarean section,
- Having a single baby,
- Between the ages of 19-35,
- Literate
Key exclusion criteria (3 listed)
- Having a premature baby,
- Mother and baby have a disease that prevents massage,
- Loss of vision and hearing.
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 |
|---|---|---|
| Baby MassageBaby massage training (30 minutes) was given to primiparous mothers before they were discharged from the hospital. Baby massage training consists of sections that explain the importance of massage, preparation for massage, stages of baby massage and situations that need attention. Primiparous mothers were told to do this massage to their babies in the postpartum period. Baby massage video CD, brochure and baby oil were given to primiparous mothers for an effective baby massage. | Behavioural | Experimental arms |
Primary outcome
Postpartum depression
Time frame: Postpartum 42nd day
The Edinburgh postpartum depression scale (EPDS) was used to determine the level of postpartum depression. EPDS is a 4-point Likert-type scale consisting of 10 questions and is scored between 0-3. The total score of the scale is obtained by summing the item scores. People with a score above 12 points are considered a risk group. The lowest score is 0 and the highest score is 30. Primiparous mothers answered before training (pretest) and postpartum 42nd day (posttest).
Maternal attachment
Time frame: Postpartum 42nd day
The level of maternal attachment was assessed using the " The Maternal Attachment Inventory (MAI)". The inventory consists of 26 Likert type items. Each item is scored between 1 and 4. Therefore, the minimum score of the inventory is 26 and the maximum score is 104. A high score indicates high attachment to the mother. Primiparous mothers answered on postpartum 42nd day (posttest).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- 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.
Ayla KORKMAZ, asst. prof. principal investigator
Tokat Gaziosmanpaşa University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baby Massage in people with Depression, Postpartum and Maternal Behavior, run by Tokat Gaziosmanpasa University 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 6 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: status not confirmed, as of the sponsor's last update on 14 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayla KORKMAZ, asst. prof. ((0356) 252 16 16, ayla.korkmaz@gop.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postpartum depression (time frame: Postpartum 42nd day). 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 14 Apr 2023.