| CTRI Number |
CTRI/2024/07/071282 [Registered on: 25/07/2024] Trial Registered Prospectively |
| Last Modified On: |
21/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Impact of Education on Knowledge and Practices about Pelvic Organ Prolapse and Urinary Incontinence in Menopausal Women - An Analytical Study |
|
Scientific Title of Study
|
Impact of Educational Intervention on Knowledge and Practices about Pelvic Organ Prolapse and Urinary Incontinence in Menopausal Women - An Analytical 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 |
Sanjana Tahiliani |
| Designation |
Post Graduate (PG) Student |
| Affiliation |
KLE Academy of Higher Education and Research Institute of Physiotherapy |
| Address |
Department of OBG Physiotherapy
KAHER Institute Of Physiotherapy
Belgaum
KARNATAKA
590010
India |
| Phone |
7738762851 |
| Fax |
- |
| Email |
tahilianisanjana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arati Mahishale |
| Designation |
Professor and Head, Department of Obstetrics and Gynecology physiotherapy |
| Affiliation |
KLE Academy of Higher Education and Research Institute of Physiotherapy |
| Address |
Department of OBG Physiotherapy
KAHER Institute Of Physiotherapy
Belgaum
KARNATAKA
590010
India |
| Phone |
9632822622 |
| Fax |
- |
| Email |
mphysioarati@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sanjana Tahiliani |
| Designation |
Post Graduate (PG) Student |
| Affiliation |
KLE Academy of Higher Education and Research Institute of Physiotherapy |
| Address |
Department of OBG Physiotherapy
KAHER Institute Of Physiotherapy
Belgaum
KARNATAKA
590010
India |
| Phone |
7738762851 |
| Fax |
- |
| Email |
tahilianisanjana@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Academy of Higher Education and Research Institute of Physiotherapy, Belagavi
KARNATAKA 590010 India. |
|
|
Primary Sponsor
|
| Name |
Sanjana Tahiliani |
| Address |
KLE Academy of Higher Education and Research Institute of
Physiotherapy, Belagavi KARNATAKA 590010 India |
| 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 Sanjana Tahiliani |
KLES Dr Prabhakar Kore Hospital & Medical Research Centre |
KLES Dr. Prabhakar Kore Hospital & MRC
Department of OBG Physiotherapy
Physiotherapy OPD room number 28
Nehru Nagar, Belagavi – 590010 Karnataka, India
Belgaum
KARNATAKA |
7738762851
-
tahilianisanjana@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KIPT Institutional Research and Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Menopausal Women |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Pamphlets |
The subjects will be
given pamphlets after taking the Pre-questionnaire and then
subjects will be asked to go
through the pamphlets. The subjects will then be asked to fill post-questionnaires. The time duration for comparator agent will be 20 minutes |
| Intervention |
Pamphlets, Video Module and Pelvic Model |
The subjects will be
made to fill out the
pre-questionnaire and then
watch the educational video, go through the pamphlets and will be given explanation using pelvic model. The subjects will then be asked to fill post-questionnaires. The intervention will take 20 minutes. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1.Nulliparous and parous Perimenopausal, Menopausal and Postmenopausal women between age 40 -60 years.
2.Able to read and write, as determined by study personnel.
3.Subjects willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
Blind and mentally challenged women |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prolapse and Incontinence Knowledge Questionnaire |
20 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="308"
Sample Size from India="308"
Final Enrollment numbers achieved (Total)= "308"
Final Enrollment numbers achieved (India)="308" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/09/2024 |
| 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="11"
Days="30" |
|
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
|
This study is being conducted to know the impact of educational intervention on knowledge and practices about pelvic organ prolapse and urinary incontinence in menopausal women. The study will be conducted in Belagavi city. At the beginning of the study, tools used for educational intervention like pamphlets and a video module will be prepared. Then the participants will be recruited as per inclusion and exclusion criteria and will be allocated randomly to control and intervention group. The participants will be asked to fill out the questionnaire pre and post-intervention. The questionnaire included multiple-choice questions about the pelvic organ prolapse and urinary incontinence. The interventional group will receive the Pamphlet, video module and explanation using pelvic model. The control group will receive only pamphlets. Each group will obtain one session, for 20 minutes. The educational program will be presented in a clear, simple, concise and focused form. Then, a post-test will be done where the subjects will be asked to again fill the questionnaire to measure the effect of the educational intervention on knowledge and practices about pelvic organ prolapse and urinary incontinence. The pre and post-values will be noted on the data collection sheet and these observations will be further presented in tabular form and statistical analysis will be done. |