- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06475885
Effect of Baby Massage on Postnatal Maternal Attachment and Depression
June 19, 2024 updated by: Ceyda SARPER ERKILIC, Gazi University
Effect of Baby Massage on Postnatal Maternal Attachment and Depression: Randomized Controlled Study
This study aims to examine the effects of providing infant massage training to mothers in the early postpartum period with the goal of preventing postpartum depression and enhancing maternal bonding.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Postpartum depression is a common and serious mood disorder influenced by various factors.
The global prevalence of postpartum depression has been identified as 17.22%.
Depressive symptoms experienced by the mother can affect her daily activities and have a negative impact on infant care.
Postpartum depression can also affect mother-infant bonding.
A healthy bond between the mother and the baby supports the baby in feeling secure, emotionally satisfied, and adapting to the world.
Infant massage has been encouraged in recent years for mothers as it can create positive effects on both depression and maternal attachment.
This study provided infant massage training to mothers in the early postpartum period with the aim of preventing postpartum depression and enhancing maternal attachment.
The Edinburgh Postnatal Depression Scale (EPDS) was administered to participants on the 14th day postpartum, and those with a score of 12 or below were included in the study.
A total of 70 participants were randomly assigned to either the experimental group (35 participants) or the control group (35 participants).
The experimental group received a 5-week International Association of Infant Massage (IAIM) Infant Massage Program starting from the 14th day postpartum.
The control group did not receive any training or intervention.
At the end of the 5 weeks, participants were assessed using the Edinburgh Postnatal Depression Scale and the Maternal Attachment Inventory.
The study examined whether there were differences in the mean scores of the scales between the groups.
Study Type
Interventional
Enrollment (Actual)
70
Phase
- Not Applicable
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
-
-
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Ankara, Turkey, 06510
- Koru Hospital
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Primiparous
- Singleton pregnancy
- Delivery at term (37-42 weeks of gestation)
- Edinburgh Postnatal Depression Scale score ≤ 12
- No physical health issues preventing massage
- No history of psychiatric illness (self-reported)
- At least basic literacy
- Residing in Ankara
- No previous training in infant massage
- Speaking the same language as the researcher
- Absence of any anomaly, malformation, or health issue preventing massage (for infants)
Exclusion Criteria:
- Not having completed the infant massage training
- Wanting to withdraw from the study for any reason
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
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group Receiving Infant Massage Training
The experimental group received a 5-week International Association of Infant Massage (IAIM) Infant Massage Program starting from the 14th day postpartum.
|
The experimental group received the International Association of Infant Massage (IAIM) Infant Massage Program starting from day 14 postpartum for a duration of 5 weeks.
|
|
No Intervention: Infant massage training not provided group
The control group received no training or intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Edinburgh Postnatal Depression Scale
Time Frame: One month
|
The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item measure used as a screening tool to identify the risk of depression, but it is not intended for diagnostic purposes.
Each question on the scale is scored from 0 to 3, with the maximum possible score being 30.
The 1st, 2nd, and 4th questions are scored 0-1-2-3, while the 3rd, 5th, 6th, 7th, 8th, 9th, and 10th questions are scored 3-2-1-0.
The cut-off point for the scale is 13, with scores of 13 and above indicating the presence of depression.
In this study, the scale was administered to participants on the 14th and 45th days postpartum.
The difference between the mean scores of the Edinburgh Postnatal Depression Scale in the experimental group and the mean scores in the control group was examined to determine if it is statistically significant (p<0.05
indicates significance).
|
One month
|
|
Maternal Attachment Scale
Time Frame: one day
|
The Maternal Attachment Inventory (MAI) is a unidimensional scale designed to measure the attachment between a mother and her baby.
It consists of 26 items, each rated on a 4-point Likert scale ranging from "always" to "never."
The scale is scored as follows: "Always = 4 points," "Frequently = 3 points," "Sometimes = 2 points," and "Never = 1 point."
Higher total scores indicate higher levels of maternal attachment.
The minimum possible score on the scale is 26, and the maximum possible score is 104.
In this study, the scale was administered to participants on the 45th day postpartum.
The difference between the mean scores of the Maternal Attachment Inventory in the experimental group and the mean scores in the control group was examined to determine if it is statistically significant (p<0.05
indicates significance).
|
one day
|
|
he relationship between the Edinburgh Postnatal Depression Scale and Maternal Attachment Scale.
Time Frame: one day
|
The relationship between the mean scores of the Edinburgh Postnatal Depression Scale and the mean scores of the Maternal Attachment Scale administered to participants on the 45th day postpartum was examined to determine if it is statistically significant (p<0.05
indicates significance).
|
one day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ceyda Sarper-Erkılıç, Gazi University
- Principal Investigator: Ayten Şentürk-Erenel, Lokman Hekim Üniversitesi
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)
December 25, 2022
Primary Completion (Actual)
June 18, 2023
Study Completion (Actual)
June 18, 2023
Study Registration Dates
First Submitted
June 13, 2024
First Submitted That Met QC Criteria
June 19, 2024
First Posted (Actual)
June 26, 2024
Study Record Updates
Last Update Posted (Actual)
June 26, 2024
Last Update Submitted That Met QC Criteria
June 19, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GaziU-CSE-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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