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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Infant Massage Program
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gazi University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 25, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 18, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 18, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 13, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 26, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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