| CTRI Number |
CTRI/2024/09/073680 [Registered on: 10/09/2024] Trial Registered Prospectively |
| Last Modified On: |
15/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of yoga and mindfulness on the quality of life among female who are taking infertility treatment |
|
Scientific Title of Study
|
Role of Yoga and Mindfulness-Based Interventions on the Quality of Life Among Women Undergoing Infertility Treatment |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pooja Dogra |
| Designation |
Assistant Professor |
| Affiliation |
Chitkara University |
| Address |
GB 501, Assistant Dean office
5th floor
Department: Chitkara School of Health Sciences
Chitkara University
Rajpura GB 501, Assistant Dean office
5th floor
Department: Chitkara School of Health Sciences
Chitkara University
Rajpura Patiala PUNJAB 140401 India |
| Phone |
8146433948 |
| Fax |
|
| Email |
pooja.dogra@chitkara.edu.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Pooja Dogra |
| Designation |
Assistant Professor |
| Affiliation |
Chitkara University |
| Address |
GB 501, Assistant Dean office
5th floor
Department: Chitkara School of Health Sciences
Chitkara University
Rajpura GB 501, Assistant Dean office
5th floor
Department: Chitkara School of Health Sciences
Chitkara University
Rajpura Patiala PUNJAB 140401 India |
| Phone |
8146433948 |
| Fax |
|
| Email |
pooja.dogra@chitkara.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Pooja Dogra |
| Designation |
Assistant Professor |
| Affiliation |
Chitkara University |
| Address |
GB 501, Assistant Dean office
5th floor
Department: Chitkara School of Health Sciences
Chitkara University
Rajpura GB 501, Assistant Dean office
5th floor
Department: Chitkara School of Health Sciences
Chitkara University
Rajpura Patiala PUNJAB 140401 India |
| Phone |
8146433948 |
| Fax |
|
| Email |
pooja.dogra@chitkara.edu.in |
|
|
Source of Monetary or Material Support
|
| Fortis Bloom IVF Centre, 3rd Floor, Fortis hospital, Sector 62, Sahibzada Ajit Singh Nagar, Lamba, Punjab, 160062 |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NIL] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pooja Mehta |
Fortis Hospital |
Fortis Bloom IVF Centre, 3rd Floor, Fortis hospital, Sector 62, Sahibzada Ajit Singh Nagar, Lamba, Punjab, 160062 Rupnagar PUNJAB |
9872888863
bloomivfmohali@gmail.com |
| Priyanka Choudhary |
Fortis Hospital |
Fortis Bloom IVF Centre, 3rd Floor, Fortis hospital, Sector 62, Sahibzada Ajit Singh Nagar, Lamba, Punjab, 160062 Rupnagar PUNJAB |
9103016581
priyanka.choudhary22phd@chitkara.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Fortis Hospital Mohali |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Females undergoing infertility treatment |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Yoga and Mindfulnes |
Yoga and mindfulness asanas will be given to females for 12 weeks
Yoga will be given for 5 days per week for 45-60 minutes. Mindfulness will be given 20 minutes for 5 days per week. |
| Comparator Agent |
Yoga and Mindfulness based interventions |
Yoga, Mindfulness, Combined Yoga and Mindfulness-based interventions |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Participants with a diagnosis of infertility.
Participants aged within the range of 18-45 years.
Women participants who are married
|
|
| ExclusionCriteria |
| Details |
Individuals are unable to provide informed consent or lack decision-making capacity.
Individuals with underlying pathology of the spine.
Participants with a history of severe psychiatric disorders and use of psychoactive substances.
Women who have regularly engaged in mindfulness or yoga practices before the study.
Participants currently enrolled in other stress reduction or mind-body intervention programs.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The overall levels of anxiety and stress are high in females with infertility due to the anxiety and stress there is a poor quality of life |
Yoga and Mindfulness Interventions will be given for 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The overall levels of anxiety and stress are low in females with infertility and due to the low level of anxiety and stress , quality of life is improve |
After the 12 weeks interventions |
|
|
Target Sample Size
|
Total Sample Size="95" Sample Size from India="95"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/09/2024 |
| Date of Study Completion (India) |
15/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="3" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is a randomised parallel-group trial in which the overall levels of anxiety and stress are high, which can lead to a poor quality of life in females who are undergoing infertility treatment. Yoga and mindfulness-based interventions given to the groups to lower anxiety and stress levels and improve the quality of life. In this study, findings were that combined yoga and mindfulness based interventions were more effective as compare to yoga and mindfulness alone. |