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Effect of Yoga on Postpartum Depression

Primary Purpose

Yoga

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
yoga training
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Yoga focused on measuring Yoga, Postpartum, depression

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)Accepts Healthy Volunteers

Inclusion Criteria:

  • Their ages were ranged from 20-35 years
  • Their body mass index was less than 30 kg/m2

Exclusion Criteria:

  • cardiac arrhythmia,
  • respiratory problems,
  • uncontrolled Type I diabetes

Sites / Locations

  • Ghada Ebrahim Elrefaye

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

yoga

antidepressant

Arm Description

The yoga program consisted of 12 exercises, , 50 minutes daily, 7 days per week for 12 weeks (Total 84 sessions).

All women in group A were treated by antidepressant only for 12 weeks

Outcomes

Primary Outcome Measures

BMI assessment
The weight and height of each woman in both groups (A & B) were measured

Secondary Outcome Measures

Zung self-rating depression scale
There are ten positively worded and ten negatively worded questions. Each question is scored on a scale of 1 through 4

Full Information

First Posted
June 7, 2021
Last Updated
June 7, 2021
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04923698
Brief Title
Effect of Yoga on Postpartum Depression
Official Title
Yoga on Postpartum Depression
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
January 24, 2019 (Actual)
Primary Completion Date
March 30, 2020 (Actual)
Study Completion Date
March 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

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

5. Study Description

Brief Summary
This study was conducted to investigate the effect of yoga on postpartum depression. Subjects: Forty primipara women with postpartum depression (PPD) selected randomly from Kasr El Ainy University Hospital in Cairo complaining of postpartum depression at least one month after childbirth shared in this study.
Detailed Description
This study was conducted to investigate the effect of yoga on postpartum depression. Subjects: Forty primipara women with postpartum depression (PPD) selected randomly from Kasr El Ainy University Hospital in Cairo complaining of postpartum depression at least one month after childbirth shared in this study. Group A (Control group): It consisted of 20 women and treated by antidepressant drugs only for 12 weeks. Group B (Study group): It consisted of 20 women and treated by the same antidepressant drugs as in group A and yoga program, 50 minutes daily,7 days per week for 12 weeks (Total 84 sessions).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Yoga
Keywords
Yoga, Postpartum, depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Group A (Control group): It consisted of 20 women and treated by antidepressant drugs only for 12 weeks. Group B (Study group): It consisted of 20 women and treated by the same antidepressant drugs as in group A and yoga program, 50 minutes daily,7 days per week for 12 weeks (Total 84 sessions).
Masking
Outcomes Assessor
Masking Description
using closed envelope
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
yoga
Arm Type
Active Comparator
Arm Description
The yoga program consisted of 12 exercises, , 50 minutes daily, 7 days per week for 12 weeks (Total 84 sessions).
Arm Title
antidepressant
Arm Type
Active Comparator
Arm Description
All women in group A were treated by antidepressant only for 12 weeks
Intervention Type
Other
Intervention Name(s)
yoga training
Intervention Description
All women in group B were treated by the same antidepressant drugs as in group A and yoga program, 50 minutes daily, 7 days per week for 12 weeks (Total 84 sessions).
Primary Outcome Measure Information:
Title
BMI assessment
Description
The weight and height of each woman in both groups (A & B) were measured
Time Frame
three months
Secondary Outcome Measure Information:
Title
Zung self-rating depression scale
Description
There are ten positively worded and ten negatively worded questions. Each question is scored on a scale of 1 through 4
Time Frame
three months

10. Eligibility

Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Their ages were ranged from 20-35 years Their body mass index was less than 30 kg/m2 Exclusion Criteria: cardiac arrhythmia, respiratory problems, uncontrolled Type I diabetes
Facility Information:
Facility Name
Ghada Ebrahim Elrefaye
City
Giza
ZIP/Postal Code
12613
Country
Egypt

12. IPD Sharing Statement

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Effect of Yoga on Postpartum Depression

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