NCT04043533

Brief Summary

Aim: This study aims to identify the effectiveness of an exercise program in reducing the severity of postnatal depression in women who had a spontaneous vaginal delivery. Methods: This randomized control trial was conducted with 65 postpartum women residing in a city located in the south-eastern Turkey. In the first postpartum month, following random assignment of subjects, the experimental group (n=40) performed exercises for four weeks, and the control group (n=40) received standard cares. The participating women were administered the Edinburgh Postpartum Depression Scale.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

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

September 1, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 29, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 2, 2019

Completed
Last Updated

August 2, 2019

Status Verified

August 1, 2019

Enrollment Period

6 months

First QC Date

July 29, 2019

Last Update Submit

August 1, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Effect of exercise

    questionnaire and scale, Edinburgh Postpartum Depression Scale (EPDS) The screening scale, developed by Cox et al. (1987), aimed to identify depression risk in women in the postpartum period. It's a self-report scale that is composed of 10 items aiming to measure the individual's psychological state within the past 7 days. Each item is rated on a four-point Likert scale between 0 and 3 ("Yes, all the time", "Yes, most of the time", "No, not very often", and "No, not at all". Total score ranges between 0 and 30. Higher scores indicate the severity of depression. Aydin et al. (2004) performed the reliability and validity of the scale and identified the cut-off point for Turkish women as 12.5

    4 week

Study Arms (2)

Exercises Group

EXPERIMENTAL
Behavioral: Exercises

Control Group

NO INTERVENTION

Interventions

ExercisesBEHAVIORAL

The women in the experimental group were given information about the benefits of exercises done in the postpartum period, the time to start these exercises, and the exercises to be conducted in three different phases (mild, medium, severe). The first physical exercise practice was done in the FHC together. In line with the recommendations by ACOG (2015), the women were told to do mild and medium level exercises in the first two weeks, at least five days in a week and at least half an hour daily (ACOG, 2015). They were also told that they should do medium and severe level exercises in the following two weeks. They were asked to mark on the form what time, how long, and at what level they did the exercises every day. The education booklet that included this information and the visuals of the exercises were given to the women in the experimental group. In addition, the women were called once a week in order to check whether the training was applied.

Exercises Group

Eligibility Criteria

Age19 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • must be score of 13 and over in the Edinburgh Postpartum Depression Scale (EPDS),
  • must being between 19 and 40 years old,
  • must had a spontaneous vaginal delivery between the 38th and 42nd weeks of pregnancy,
  • must had a healthy newborn baby with 2500 gr and over

You may not qualify if:

  • postpartum obstetric complications
  • psychiatric disease history before or during pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Didem Şimşek Küçükkelepçe

Adi̇yaman, 02100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: Randomized controlled trial with a prospective pretest-posttest experimental design.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Didem Kucukkelepce

Study Record Dates

First Submitted

July 29, 2019

First Posted

August 2, 2019

Study Start

September 1, 2017

Primary Completion

February 15, 2018

Study Completion

June 15, 2018

Last Updated

August 2, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations