| CTRI Number |
CTRI/2024/07/070186 [Registered on: 08/07/2024] Trial Registered Prospectively |
| Last Modified On: |
05/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Development and content validation |
| Study Design |
Other |
|
Public Title of Study
|
Validation of pelvic floor wellness questionnaire |
|
Scientific Title of Study
|
Development and content validation of the pelvic floor wellness questionnaire for nulligravida |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nivedhya RS |
| Designation |
Master of physiotherapy student |
| Affiliation |
Department of physiotherapy Institute of physiotherapy, srinivas University |
| Address |
Department of physiotherapy Institute of physiotherapy, srinivas University, pandeshwar, Manglore
Dakshina Kannada , Karnataka
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
7902568677 |
| Fax |
|
| Email |
nivedhyars99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Radhika s Gopal |
| Designation |
Assistant professor of physiotherapy |
| Affiliation |
Institute of physiotherapy, srinivas University |
| Address |
Institute of physiotherapy, srinivas University, pandeshwar, Manglore
Dakshina Kannada , Karnataka
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
7902568677 |
| Fax |
|
| Email |
radhikaradhu1590@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nivedhya RS |
| Designation |
Master of physiotherapy student |
| Affiliation |
Department of physiotherapy Institute of physiotherapy, srinivas University |
| Address |
Department of physiotherapy Institute of physiotherapy, srinivas University, pandeshwar, Manglore
Dakshina Kannada , Karnataka
KARNATAKA
575001
India |
| Phone |
7902568677 |
| Fax |
|
| Email |
nivedhyars99@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Nivedhya RS |
| Address |
Institute of physiotherapy, srinivas University, manglore |
| Type of Sponsor |
Other [] |
|
|
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 Nivedhya RS |
Institute of physiotherapy srinivas University |
Institute of physiotherapy Department of physiotherapy srinivas University, pandeshwar, Manglore
Dakshina Kannada
KARNATAKA |
7902568677
nivedhyars99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRINIVAS UNIVERSITY ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy humans |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
24.00 Year(s) |
| Gender |
Female |
| Details |
Who are not able to understand Engish |
|
| ExclusionCriteria |
| Details |
Who are not able to understand Engish |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pelvic floor wellness questionnaire |
1day
28 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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)
|
20/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/07/2024 |
| 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 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
|
To develop a Questionnaire to assess PFM function among nulligravida and perform content validity of the same. Locally known experienced therapists who met the study’s inclusion criteria will be contacted directly or telephonically. They will be given a hard copy of the questionnaire and requested to make the corrections. Once the corrections are made questionnaire will be modified accordingly with the expert’s opinions. |