NCT05813782

Brief Summary

This study was conducted to determine the effect of baby massage on postpartum depression and maternal attachment in the postpartum period.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

September 3, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 14, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2023

Completed
Last Updated

April 14, 2023

Status Verified

April 1, 2023

Enrollment Period

8 months

First QC Date

March 23, 2023

Last Update Submit

April 12, 2023

Conditions

Depression, PostpartumMaternal BehaviorAttachment

Keywords

Primiparous motherBaby massagePostpartum depressionMaternal attachment

Outcome Measures

Primary Outcomes (2)

  • 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).

    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).

    Postpartum 42nd day

Study Arms (2)

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.

Behavioral: Baby Massage

Interventions

Baby MassageBEHAVIORAL

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.

Experimental arms

Eligibility Criteria

Age19 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfocused on primiparous mothers
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Primiparous,
  • Cesarean section,
  • Having a single baby,
  • Between the ages of 19-35,
  • Literate
  • Effective communication.

You may not qualify if:

  • Having a premature baby,
  • Mother and baby have a disease that prevents massage,
  • Loss of vision and hearing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tokat Gaziosmanpaşa University

Tokat Province, 60250, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ayla KORKMAZ, asst. prof.

    Tokat Gaziosmanpaşa University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayla KORKMAZ, asst. prof.

CONTACT

(0356) 252 16 16ayla.korkmaz@gop.edu.tr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
asst. prof.

Study Record Dates

First Submitted

March 23, 2023

First Posted

April 14, 2023

Study Start

September 3, 2022

Primary Completion

May 15, 2023

Study Completion

August 15, 2023

Last Updated

April 14, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)