NCT04923698

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

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

January 24, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 7, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 11, 2021

Completed
Last Updated

June 11, 2021

Status Verified

June 1, 2021

Enrollment Period

1.2 years

First QC Date

June 7, 2021

Last Update Submit

June 7, 2021

Conditions

Keywords

YogaPostpartumdepression

Outcome Measures

Primary Outcomes (1)

  • BMI assessment

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

    three months

Secondary Outcomes (1)

  • Zung self-rating depression scale

    three months

Study Arms (2)

yoga

ACTIVE COMPARATOR

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

Other: yoga training

antidepressant

ACTIVE COMPARATOR

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

Other: yoga training

Interventions

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).

antidepressantyoga

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghada Ebrahim Elrefaye

Giza, 12613, Egypt

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
using closed envelope
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor Department of Physical Therapy for Women's Health, Faculty of Physical therapy, Cairo University, Egypt

Study Record Dates

First Submitted

June 7, 2021

First Posted

June 11, 2021

Study Start

January 24, 2019

Primary Completion

March 30, 2020

Study Completion

March 30, 2020

Last Updated

June 11, 2021

Record last verified: 2021-06

Locations