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The Effect of an Exercise Program in Reducing the Severity of Postpartum Depression in Women

Primary Purpose

Depression, Postpartum

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercises
Sponsored by
Didem Kucukkelepce
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Depression, Postpartum

Eligibility Criteria

19 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. postpartum obstetric complications
  2. psychiatric disease history before or during pregnancy

Sites / Locations

  • Didem Şimşek Küçükkelepçe

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercises Group

Control Group

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 29, 2019
Last Updated
August 1, 2019
Sponsor
Didem Kucukkelepce
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1. Study Identification

Unique Protocol Identification Number
NCT04043533
Brief Title
The Effect of an Exercise Program in Reducing the Severity of Postpartum Depression in Women
Official Title
The Effect of an Exercise Program in Reducing the Severity of Postpartum Depression in Women: A Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
February 15, 2018 (Actual)
Study Completion Date
June 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Didem Kucukkelepce

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Postpartum depression is characterized by irritability, guilt, burnout, anxiety, sleep disorders, and somatic symptoms that could have negative effects on the mother, baby, and family. In a meta-analysis study including 219 prevalence studies from 56 countries that investigated different phases of postpartum using various data collection tools, Hahn-Holbrook et al. (2018) found the depression prevalence at the global level as 17.7% (Hahn-Holbrook, 2018). In Turkey, 23.8% of women in the postpartum period were reported to be suffering from postpartum depression, which underlines the need for health professionals to be concerned about the health of the women in the postpartum period. Exercises done in the postpartum period are reported to enable psychosocial well-being, less anxiety and depression, better cardiovascular adaptation, body fat/weight control, less bone loss caused by lactation, and less stress incontinence. Studies have generally indicated the importance of regular exercise in the postpartum period. Studies have generally indicated the importance of regular exercise in the postpartum period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Postpartum

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized controlled trial with a prospective pretest-posttest experimental design.
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercises Group
Arm Type
Experimental
Arm Title
Control Group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Effect of exercise
Description
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
Time Frame
4 week

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: postpartum obstetric complications psychiatric disease history before or during pregnancy
Facility Information:
Facility Name
Didem Şimşek Küçükkelepçe
City
Adi̇yaman
ZIP/Postal Code
02100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effect of an Exercise Program in Reducing the Severity of Postpartum Depression in Women

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