NCT06475885

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 25, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2023

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 26, 2024

Completed
Last Updated

June 26, 2024

Status Verified

June 1, 2024

Enrollment Period

6 months

First QC Date

June 13, 2024

Last Update Submit

June 19, 2024

Conditions

Keywords

Depression, PostpartumAttachmentMassageInfantNursing

Outcome Measures

Primary Outcomes (3)

  • Edinburgh Postnatal Depression Scale

    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

    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.

    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

Study Arms (2)

Group Receiving Infant Massage Training

EXPERIMENTAL

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

Infant massage training not provided group

NO INTERVENTION

The control group received no training or intervention.

Interventions

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.

Group Receiving Infant Massage Training

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Not having completed the infant massage training
  • Wanting to withdraw from the study for any reason

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Koru Hospital

Ankara, 06510, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Study Officials

  • Ceyda Sarper-Erkılıç

    Gazi University

    PRINCIPAL INVESTIGATOR
  • Ayten Şentürk-Erenel

    Lokman Hekim University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Responses from the participants were coded as "Group 1" and "Group 2" by an independent individual, and the information regarding which code corresponded to which group was not shared with the statistician. The statistician performed the data analysis and wrote the results report, which was then communicated to the researcher. Only after this stage did the researcher learn which code corresponded to which group.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A comparative study of two groups compared with a control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

June 13, 2024

First Posted

June 26, 2024

Study Start

December 25, 2022

Primary Completion

June 18, 2023

Study Completion

June 18, 2023

Last Updated

June 26, 2024

Record last verified: 2024-06

Locations