YogaNCT04923698
Effect of Yoga on Postpartum Depression
A study testing yoga training in people with Yoga, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Yoga
- What is being tested?
- yoga training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Jan 2019to 30 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Their ages were ranged from 20-35 years
- Their body mass index was less than 30 kg/m2
Who cannot join
- cardiac arrhythmia,
- respiratory problems,
- uncontrolled Type I diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Yoga on Postpartum Depression
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.
Read the 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).
- Conditions
- Yoga
- Being tested
- yoga training
- Keywords
- Yoga, Postpartum, depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
yoga trainingOther
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).
| Study group | Role | What they receive |
|---|---|---|
| yoga | Active comparator | The yoga program consisted of 12 exercises, , 50 minutes daily, 7 days per week for 12 weeks (Total 84 sessions). Receives: Other: yoga training |
| antidepressant | Active comparator | All women in group A were treated by antidepressant only for 12 weeks Receives: Other: yoga training |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI assessment
The weight and height of each woman in both groups (A \& B) were measured
Measured: three months
Secondary outcomes (1)
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
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start24 Jan 2019
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for YogaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Ebrahim El Refaye, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04923698
- Sponsor's protocol ID
- Cairo Un110
- Status last verified
- Jun 2021
- First submitted
- 7 Jun 2021
- Last updated
- 11 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoga on Postpartum Depression
- ClinicalTrials.gov ID
- NCT04923698
- Acronym / sponsor ID
- Cairo Un110
- Conditions
- Yoga
- Keywords
- Yoga, Postpartum, depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 24 Jan 2019 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 11 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| yoga | Active comparator | Other: yoga trainingThe yoga program consisted of 12 exercises, , 50 minutes daily, 7 days per week for 12 weeks (Total 84 sessions). |
| antidepressant | Active comparator | Other: yoga trainingAll women in group A were treated by antidepressant only for 12 weeks |
Who may qualify
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Their ages were ranged from 20-35 years
- Their body mass index was less than 30 kg/m2
Key exclusion criteria (3 listed)
- cardiac arrhythmia,
- respiratory problems,
- uncontrolled Type I diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| yoga trainingAll 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). | Other | antidepressant, yoga |
Primary outcome
BMI assessment
Time frame: three months
The weight and height of each woman in both groups (A \& B) were measured
1 secondary outcome
Zung self-rating depression scale
Time frame: three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing yoga training in people with Yoga, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI assessment (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2021.