NCT05038085

Brief Summary

In terms of postpartum care and depression, follow-up and controls should be continued online in order not to interrupt the follow-up and treatment of women. In this context, in order to prevent the development of postpartum depression and to increase maternal attachment, it is planned to deliver the progressive muscle relaxation exercise and individual health education program that we planned in our study through online applications. This study will be conducted to evaluate the effect of online health education and progressive muscle relaxation exercise program on postpartum depression and maternal attachment.The study was planned as a parallel randomized controlled experimental study conducted in a Family Health Center in Ankara, with a single-center, stratified block randomization (parity: primiparous, multiparous; EPDS score: 0-9, 10-30).The number of pregnant women to be included in the study was calculated as 56.Personal Information Form, Prenatal Attachment Scale, Edinburgh Postpartum Depression Scale and Postpartum Attachment Scale will be used to collect data.

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
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

July 16, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 8, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

October 25, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

April 14, 2022

Status Verified

April 1, 2022

Enrollment Period

6 months

First QC Date

July 16, 2021

Last Update Submit

April 7, 2022

Conditions

Keywords

postpartum depressionmaternal attachmentprogressive muscle relaxation exerciseonline health education

Outcome Measures

Primary Outcomes (1)

  • The Edinburgh Postpartum Depression Scale (EPDS), Prenatal Attachment Scale (PAS)

    PAS and EPDS will be administered to women at 35 weeks of pregnancy.The scales will be converted into an online questionnaire and mothers will be asked to fill in by sending their contact address. The lowest score that can be obtained from EPDS is 0 and the highest score is 30.Women with a total scale score higher than the cut-off point are considered to be a risk group in terms of postpartum depression.A minimum of 21 points and a maximum of 84 points can be obtained from the PBE. The increase in the score obtained by the pregnant indicates that the level of attachment also increases.

    prenatal 35. week

Secondary Outcomes (1)

  • The EPDS, The Postpartum Attachment Scale (PPAS)

    postpartum 6. week

Study Arms (2)

experimental group application

EXPERIMENTAL

progressive muscle relaxation exercise health education

Behavioral: progressive muscle relaxation exercise

control group application

NO INTERVENTION

No intervention will be made in the control group.

Interventions

36-37 with pregnant women in the experimental group. There will be two online interviews starting from week one. Before the first interview, the PMRE video will be sent to the women, explained by the researcher. In the first meeting, basic information about postpartum depression and what to do to prevent postpartum depression and its treatment will be explained. The women will then be asked to describe the PKGE. "Relaxation Exercises CD Audio Recordings" belonging to the Turkish Psychological Association will be sent to women, and they will be asked to perform PMRE at least 3 days a week until delivery, accompanied by the instructions on the CD. In the second meeting; maternal attachment will be explained. In this interview, women will be asked to continue to do PMRE at least 3 days a week from the day they feel ready, starting at the latest 1 week after delivery.

Also known as: health education
experimental group application

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being at least literate
  • Being at least 18-35 years old
  • Being between 35-36 weeks of pregnancy
  • Not having any psychiatric diagnosis
  • Not being pregnant at risk
  • Being pregnant naturally
  • Having the technical means to use Whatsapp® application
  • Volunteering to participate in the research
  • Not having a communication barrier

You may not qualify if:

  • Having a stillbirth
  • Hospitalization of the newborn
  • Hospitalization of the mother
  • The woman's desire to leave the research
  • Not filling out data collection tools
  • Unable to reach for training/consulting
  • The woman's progressive relaxation exercise less than three days a week

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, Çankaya, 06440, 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

  • Şengül Yaman Sözbir, Assoc.

    Gazi University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

CANAN UÇAKCI ASALIOĞLU, MD

CONTACT

Şengül YAMAN SÖZBİR, assoc.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: parallel randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research asistant

Study Record Dates

First Submitted

July 16, 2021

First Posted

September 8, 2021

Study Start

October 25, 2021

Primary Completion

April 8, 2022

Study Completion

June 1, 2022

Last Updated

April 14, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations