| CTRI Number |
CTRI/2024/08/073041 [Registered on: 28/08/2024] Trial Registered Prospectively |
| Last Modified On: |
24/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effect of Integrated community based nursing intervention in women who have attained menopause to assess quality of life, symptoms of menopause and psychological parameters like anxiety, depression and irritability, in rural areas of Bagalkot, Karnataka, India. |
|
Scientific Title of Study
|
A study to assess the effectiveness of integrated community based nursing intervention on symptom experience, quality of life and selected psychosocial parameters among post menopausal women residing in selected rural areas of Bagalkot district, Karnataka, India. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jayashri G Itti |
| Designation |
Principal |
| Affiliation |
hri B.V.V.S institute of Nursing sciences, Bagalkot Raichur road, Bagalkot. |
| Address |
Department of Community Health Nursing
Old BVV Sangha campus
Shri B.V.V.S institute of Nursing sciences, Bagalkot Raichur road, Bagalkot.
Bagalkot
KARNATAKA
587101
India |
| Phone |
9448187697 |
| Fax |
|
| Email |
jayashri.g.itti@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deelip S Natekar |
| Designation |
Principal |
| Affiliation |
B.V.V.S Sajjalashree Institute of Nursing sciences, Navanagar, Bagalkot |
| Address |
Department of Community Health nursing, SNMC Campus, B.V.V.S Sajjalashree Institute of Nursing sciences, Navanagar, Bagalkot
Bagalkot
KARNATAKA
587102
India |
| Phone |
09844802937 |
| Fax |
|
| Email |
deelipsn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deelip S Natekar |
| Designation |
Principal |
| Affiliation |
B.V.V.S Sajjalashree Institute of Nursing sciences, Navanagar, Bagalkot |
| Address |
Department of Community Health Nursing, SNMC Campus, B.V.V.S Sajjalashree Institute of Nursing sciences, Navanagar, Bagalkot
Bagalkot
KARNATAKA
587102
India |
| Phone |
09844802937 |
| Fax |
|
| Email |
deelipsn@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self-Jayashri G Itti
Shri BVVS institute of Nursing sciences, Bagalkot, Karnataka, 587101 |
|
|
Primary Sponsor
|
| Name |
Mrs Jayashri GItti |
| Address |
Shri B.V.V.S institute of Nursing sciences, Bagalkot Raichur road, Bagalkot, Karnataka, India-587101 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Rajashekhargauda Hiregoudar |
Shivaganga Health care centre. |
Seminar hall, Department of Community medicine, Shivaganga health care centre, Shirur, Bagalkot.587120
Bagalkot
KARNATAKA |
8618810173
rajashekhargouda72@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SIONS INSTITUTIONAL ETICAL COMMITTEE ON HUMAN SUBJECTS RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Women attained menopause. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
community based education regarding menopausal symptoms and their control for 90 days |
Educating the post menopausal women regarding menopause and related symptoms and the various strategies of reducing those symptoms for 90 days. |
| Intervention |
Integrated community based nursing intervention for 90 days |
Training Sudarshan kriya yoga. Yogasana poses with appropriate techniques.
provision of education regarding incorporation of healthy diet and lifestyle, for 90 days. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
Women who have attained menopause.
Residing in rural area
|
|
| ExclusionCriteria |
| Details |
Women who have mental illness and not able to follow instructions.
Women with musculoskeletal injury and obtaining treatment. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Anxiety, irritability and depression |
first day of commencement of intervention and 30 days after completion of intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Symptoms of menopause: hot flush, sweating, sleeping problem and vaginal dryness |
first day of commencement of intervention and 30 days after completion of intervention. |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
20/09/2024 |
| 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="0"
Months="8"
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
|
It is a non randomized interventional study to determine the effectiveness of integrated community based nursing intervention on symptom
experience, quality of life and selected psychosocial parameters among post
menopausal women residing in selected rural areas. The study participants are women who have attained menopause. The integrated community based nursing intervention includes training of Sudarshana Kriya Yoga, appropriate diet and healthy life style practices. The effect of intervention will be observed on Menopausal symptoms, anxiety, irritability and depression. |