| CTRI Number |
CTRI/2024/12/078153 [Registered on: 16/12/2024] Trial Registered Prospectively |
| Last Modified On: |
21/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Other |
|
Public Title of Study
|
Effectiveness of Yoga Nidra |
|
Scientific Title of Study
|
Effectiveness of Yoga Nidra on Stress and Insomnia among postmenopausal women in self-help groups at Mangaluru |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms PREETHA SONIA DSOUZA |
| Designation |
post graduate student (Nursing) |
| Affiliation |
Father Muller College of Nursing |
| Address |
Father Muller College of Nursing, Obstetrics and Gynaecological Nursing, 1st Msc Nursing, Kankanady, Mangaluru, Dakshina Kannada, Karnataka, India
Dakshina Kannada KARNATAKA 575002 India |
| Phone |
8861893796 |
| Fax |
|
| Email |
soniapreetha86@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Mrs Ramyashree S |
| Designation |
Assistant Professor |
| Affiliation |
Father Muller College of Nursing |
| Address |
Father Muller College of Nursing, Obstetrics and Gynaecological Nursing Department, Kankanady, Mangaluru, Dakshina Kannada, Karnataka, India
Dakshina Kannada KARNATAKA 575002 India |
| Phone |
7349426322 |
| Fax |
|
| Email |
ramyaashwath@fathermuller.in |
|
Details of Contact Person Public Query
|
| Name |
Mrs Thamizharasi N |
| Designation |
Assistant Professor |
| Affiliation |
Father Muller College of Nursing |
| Address |
Father Muller College of Nursing, Obstetrics and Gynaecological Nursing Department, Kankanady, Mangaluru, Dakshina Kannada, Karnataka, India
Dakshina Kannada KARNATAKA 575002 India |
| Phone |
9481068009 |
| Fax |
|
| Email |
thamizharasi15@fathermuller.in |
|
|
Source of Monetary or Material Support
|
| Ms Preetha Sonia Dsouza
Father Muller College of Nursing Kankanady
Mangaluru taluk
Dakshina Kannada district
karnataka state
India-575002 |
|
|
Primary Sponsor
|
| Name |
Ms Preetha Sonia Dsouza |
| Address |
Father Muller College of Nursing, Obstetrics and Gynaecological Nursing, 1st MSc Nursing, Kankanady, Mangaluru, Dakshina Kannada, Karnataka
India-575002 |
| Type of Sponsor |
Other [Self funded] |
|
|
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 |
| Sr Helen Fernandes |
Spandana Trust- Social Welfare Unit |
Infant Marys Convent, Sisters of Charity,Jeppu, Mangaluru, Dakshina Kannada, Karnataka, India Dakshina Kannada KARNATAKA |
8867601060
spandanatrust03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Institutional Ethics Committee (FMIEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Post Menopausal Women |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Yoga Nidra |
n this present study researcher would like to investigate the Effectiveness of Yoga Nidra on Stress and Insomnia among postmenopausal women who belong to self-help groups at Mangaluru. A researcher has certified and completed her training in Yoga Nidra. Permission letter has been obtained from the administrator of Spandana Trust Jeppu Mangaluru and Father Muller Ethics Committee has permitted to conduct research study. Postmenopausal women who completed menopause from past twelve months were selected as samples in this study. In this present study researcher used true experimental design. Sample size calculation was done by institutional biostatistician and this present study sample size is 60 experimental group thirty and control group thirty and samples were selected by random sampling method. Investigator obtains consent from the subjects pre test will be be given to assess Stress (Perceived Stress Scale) and Insomnia(Insomnia Severity Index) levels in the experimental group followed by Yoga Nidra guided meditation will be given for every day evening 30 minutes for 30 days, on 30th day post test will be given to assess stress and insomnia level. Investigator obtains consent from the control group subjects, a pre-test will be given to assess stress and insomnia levels followed by a post-test will be given on the 31st day. Results will be analyzed by the investigator. |
| Comparator Agent |
Yoga Nidra on stress and insomnia among post menopausal women |
In this present study researcher would like to investigate the Effectiveness of Yoga Nidra on Stress and Insomnia among postmenopausal women who belong to self-help groups at Mangaluru. A researcher has certified and completed her training in Yoga Nidra. Permission letter has been obtained from the administrator of Spandana Trust Jeppu Mangaluru and Father Muller Ethics Committee has permitted to conduct research study. Postmenopausal women who completed menopause from past twelve months were selected as samples in this study. In this present study researcher used true experimental design. Sample size calculation was done by institutional biostatistician and this present study sample size is 60 experimental group thirty and control group thirty and samples were selected by random sampling method. Investigator obtains consent from the subjects pre test will be be given to assess Stress (Perceived Stress Scale) and Insomnia(Insomnia Severity Index) levels in the experimental group followed by Yoga Nidra guided meditation will be given for every day evening 30 minutes for 30 days, on 30th day post test will be given to assess stress and insomnia level. Investigator obtains consent from the control group subjects, a pre-test will be given to assess stress and insomnia levels followed by a post-test will be given on the 31st day. Results will be analyzed by the investigator. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
Women who has experienced menopause for a period of 12 months and belongs to self help group |
|
| ExclusionCriteria |
| Details |
who are practicing yoga and meditation, receiving hormonal therapy, stress and anxiety disorder, history of hypertension and diabetes |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| yoga nidra will reduce the stress and insomnia |
yoga nidra will reduce the stress and insomnia after 4 weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| yoga nidra will help in reduction of post menopausal symptoms |
30 days |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
03/01/2025 |
| 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="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
In this present study researcher would like to investigate the Effectiveness of Yoga Nidra on Stress and Insomnia among postmenopausal women who belongs to self help groups at Mangaluru. Researcher has certified completed her training in Yoga Nidra. Permission letter has obtained from the administrator of Spandana Trust Jeppu Mangaluru and Father Muller Ethics Committee has permitted to conduct research study. Postmenopausal women who completed menopause from past twelve months were selected as samples in this study. In this present study researcher used true experimental design. Sample size calculation was done by institutional biostatistician and this present study sample size is 60 experimental group thirty and control group thirty and samples were selected by random sampling method. Investigator obtains consent from the subjects pre test will be given to assess Stress (Perceived Stress Scale) and Insomnia(Insomnia Severity Index) level to experimental group followed by Yoga Nidra guided meditation will be given for every day evening 30 minutes for 30 days, on 30th day post test will be given to assess stress and insomnia level. Investigator obtains consent from the control group subjects, pre test will be given to assess stress and insomnia level followed by post test will be given on 31st day. Results will be analyzed by the investigator. |