The Effect of an Exercise Program in Reducing the Severity of Postpartum Depression in Women
1 other identifier
interventional
80
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2017
Shorter than P25 for not_applicable
1 active site
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
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2018
CompletedFirst Submitted
Initial submission to the registry
July 29, 2019
CompletedFirst Posted
Study publicly available on registry
August 2, 2019
CompletedAugust 2, 2019
August 1, 2019
6 months
July 29, 2019
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
EXPERIMENTALControl Group
NO INTERVENTIONInterventions
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.
Eligibility Criteria
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)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- 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