| CTRI Number |
CTRI/2025/11/097892 [Registered on: 21/11/2025] Trial Registered Prospectively |
| Last Modified On: |
21/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Yoga Nidra to reduce menopausal symptoms in postmenopausal women |
|
Scientific Title of Study
|
Effect of Yoga Nidra on menopausal symptoms in postmenopausal women: A single group pre - post study |
| 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 N S Sharmila |
| Designation |
Postgraduate scholar ( Department of Yoga ) |
| Affiliation |
Government yoga and naturopathy medical college and hospital, chennai |
| Address |
Department of Yoga, second floor, Postgraduate block, Government yoga and naturopathy medical college and hospital, chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
7871519224 |
| Fax |
|
| Email |
sharminns019@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K S Lakshmi |
| Designation |
Professor and head, Department of Yoga |
| Affiliation |
Government yoga and naturopathy medical college and hospital, chennai |
| Address |
Department of Yoga, second floor, Postgraduate block, Government yoga and naturopathy medical college and hospital, Arumbakkam, Chennai - 600106
Chennai
TAMIL NADU
600 106
India |
| Phone |
9841073029 |
| Fax |
|
| Email |
lakshmikaran28@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr N S Sharmila |
| Designation |
Postgraduate scholar ( Department of Yoga ) |
| Affiliation |
Government yoga and naturopathy medical college and hospital, chennai |
| Address |
Department of Yoga, second floor, Postgraduate block, Government yoga and naturopathy medical college and hospital, chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
7871519224 |
| Fax |
|
| Email |
sharminns019@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government yoga and naturopathy medical college and hospital, arumbakkam, chennai-600 106 |
|
|
Primary Sponsor
|
| Name |
Government yoga and naturopathy medical college and hospital |
| Address |
Government yoga and naturopathy medical college and hospital, chennai - 600 106. |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr N S Sharmila |
Government Yoga and Naturopathy Medical College and Hospital, Arumbakkam, Chennai - 600 106. |
Government Yoga and Naturopathy Medical College and Hospital, Department of Yoga, Second floor, Postgraduate department, Arumbakkam, Chennai - 106
Chennai
TAMIL NADU |
7871519224
sharminns019@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Yoga and Naturopathy Medical College and Hospital, Chennai. Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N951||Menopausal and female climactericstates, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Yoga Nidra for postmenopausal women with menopausal symptoms. |
Participants will be asked to lie down in shavasana with body straight, legs slightly apart, palms facing upward and eyes closed. Physical movements will be avoided as deep breath release worries, cultivating relaxation while following instructors voice. Awareness will move through relaxation, resolution of intent, rotation of consciousness, breath observation and awakening sensation of heaviness, lightness, heat and cold. Focus will then turn to the inner space before the closed eye, visualizing a transparent screen extending into infinite inner space. Visualization of various images will follow, engaging the awareness, emotion and imagination. The initial resolve will be recalled and repeated. Finally all efforts will be released as the natural breathing is observed, the body slowly reawakened, seated upright and eyes will be opened to complete the 25 minutes practice. Yoga Nidra should be practiced for 25 minutes per day for 6 days per week for 2 weeks. Assessment of Electro Dermal Activity, Menopausal rating scale, Pittsburg sleep quality index and Depression, anxiety, stress scale will be taken before the first session and 2 weeks after the last session of the intervention. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1) Postmenopausal women with natural menopause
2) Postmenopausal women with Menopausal rating score of atleast 12 or more
3)Postmenopausal women who are willing to give consent. |
|
| ExclusionCriteria |
| Details |
1) Postmenopausal women who are practicing any other yoga practices regularly for the past 30 days
2) Postmenopausal women participating any other study
3) Postmenopausal women with surgical (artificial) menopause
4) Postmenopausal women experiencing severe bleeding
5) Postmenopausal women under hormonal therapy
6) Postmenopausal women who are unable to lie in supine for 25 minutes
7) Postmenopausal women with cognitive impairment
8) Postmenopausal women who have undergone spinal surgery recently
9) Postmenopausal women with hearing loss |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Electro Dermal Activity (EDA) |
Electro Dermal Activity (EDA) will be measured before the first session and two weeks after the last session of the intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Menopausal rating scale
2) Pittsburg sleep quality index (PSQI)
3)Depression, anxiety, Stress scale - 21. |
Menopausal rating scale, Pittsburg sleep quality index (PSQI) and Depression, anxiety, Stress scale - 21 will be taken before and two weeks after the intervention. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
A single group pre - post study design will be adopted for this study. 30 postmenopausal women having menopausal symptoms will be recruited from Government Yoga and Naturopathy medical college and hospital, Chennai. Participants will be asked to lie down in shavasana with body straight, legs slightly apart, palms facing upward and eyes closed. Physical movements will be avoided as deep breath release worries, cultivating relaxation while following instructors voice. Awareness will move through relaxation, resolution of intent, rotation of consciousness, breath observation and awakening sensation of heaviness, lightness, heat and cold. Focus will then turn to the inner space before the closed eye, visualizing a transparent screen extending into infinite inner space. Visualization of various images will follow, engaging the awareness, emotion and imagination. The initial resolve will be recalled and repeated. Finally all efforts will be released as the natural breathing is observed, the body slowly reawakened, seated upright and eyes will be opened to complete the 25 minutes practice. Yoga Nidra should be practiced for 25 minutes per day for 6 days per week for 2 weeks. Assessment of Electro Dermal Activity, Menopausal rating scale, Pittsburg sleep quality index and Depression, anxiety, stress scale will be taken before the first session and 2 weeks after the last session of the intervention. |