- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05813782
The Effect of Baby Massage on Postpartum Depression and Maternal Attachment
The Effect of Baby Massage on Postpartum Depression and Maternal Attachment in the Postpartum Period: A Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ayla KORKMAZ, asst. prof.
- Phone Number: (0356) 252 16 16
- Email: ayla.korkmaz@gop.edu.tr
Study Locations
-
-
-
Tokat, Turkey, 60250
- Recruiting
- Tokat Gaziosmanpasa University
-
Contact:
- Ayla KORKMAZ, asst. prof.
- Email: ayla.korkmaz@gop.edu.tr
-
Principal Investigator:
- Ayla KORKMAZ, asst. prof.
-
Sub-Investigator:
- Salime MUCUK, Prof.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Primiparous,
- Cesarean section,
- Having a single baby,
- Between the ages of 19-35,
- Literate
- Effective communication.
Exclusion Criteria:
- Having a premature baby,
- Mother and baby have a disease that prevents massage,
- Loss of vision and hearing.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: No intervention arms
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: Experimental arms
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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). |
Postpartum 42nd day
|
|
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). |
Postpartum 42nd day
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ayla KORKMAZ, asst. prof., Tokat Gaziosmanpasa University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-KAEK-084
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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