| CTRI Number |
CTRI/2021/10/037676 [Registered on: 29/10/2021] Trial Registered Prospectively |
| Last Modified On: |
22/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
DYSMENORRHEA AND ITS EFFECT ON SCHOOL PERFORMANCE IN HEARING LOSS GIRLS |
|
Scientific Title of Study
|
PREVALENCE OF PRIMARY DYSMENORRHEA AND ITS EFFECT ON SCHOOL PERFORMANCE AMONG YOUNG FEMALE STUDENTS WITH HEARING IMPAIRMENT:A CROSS SECTIONAL SURVEY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR NEELAM KARANSINH RATHOD |
| Designation |
ASSISTANT PROFESSOR, I/C PRINCIPAL ARUSH PHYSIOTHERAPY COLLEGE |
| Affiliation |
ARUSH PHYSIOTHERAPY COLLEGE |
| Address |
ARUSH PHYSIOTHERAPY COLLEGE,BESIDES URMI BUNGLOWS,NR.GHEVAR CIRCLE,SHAHIBAUG,AHMEDABAD
ARUSH PHYSIOTHERAPY COLLEGE,BESIDES URMI BUNGLOWS,NR.GHEVAR CIRCLE,SHAHIBAUG,AHMEDABAD
Ahmadabad
GUJARAT
382424
India |
| Phone |
9426948310 |
| Fax |
|
| Email |
neelam_rathod128@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR NEELAM KARANSINH RATHOD |
| Designation |
ASSISTANT PROFESSOR, I/C PRINCIPAL ARUSH PHYSIOTHERAPY COLLEGE |
| Affiliation |
ARUSH PHYSIOTHERAPY COLLEGE |
| Address |
ARUSH PHYSIOTHERAPY COLLEGE,BESIDES URMI BUNGLOWS,NR.GHEVAR CIRCLE,SHAHIBAUG,AHMEDABAD
ARUSH PHYSIOTHERAPY COLLEGE,BESIDES URMI BUNGLOWS,NR.GHEVAR CIRCLE,SHAHIBAUG,AHMEDABAD
Ahmadabad
GUJARAT
382424
India |
| Phone |
9426948310 |
| Fax |
|
| Email |
neelam_rathod128@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR BHAVANA GADHVI |
| Designation |
DEAN FACULTY OF PHYSIOTHERAPY PRINCIPAL PARUL INSTITUTE OF PHYSIOTHERAPY |
| Affiliation |
parul institute of physiotherapy |
| Address |
PARUL INSTITUTE OF PHYSIOTHERAPY PARUL UNIVERSITY CAMPUS VADODARA
Vadodara
GUJARAT
390019
India |
| Phone |
9727729787 |
| Fax |
|
| Email |
bhavana.gadhavi28222@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DR NEELAM K RATHOD |
| Address |
ARUSH PHYSIOTHERAPY COLLEGE BESIDE URMI BUNGLOWS,NR. RAKSHA SHAKTI UNIVERSITY CIRCLE,SAHIBAUG,AHMEDABAD |
| Type of Sponsor |
Other [individual] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| jani sir |
samarpan muk-badhir shishu vidhya mandir |
block no111 ,ch type, sector-28 gandhinagar
Gandhinagar
GUJARAT |
07923211332
samarpanmuk28@gmail.com |
| JUHI PANDYA |
SCHOOL FOR DEAF-MUTES SOCIETY |
OPP.TIMES OF INDIA,ASHRAM ROAD AHMEDABAD
Ahmadabad
GUJARAT |
8347874757
deaf_muteschool08@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| SAMARPAN MUK BADIR SHISHU VIDHYAMANDIR |
No Objection Certificate |
| sangini hospital ethics committee |
Approved |
| SCHOOL FOR DEAF MUTES SOCIETY |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
DEAF AND MUTE YOUNG GIRLS |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
20.00 Year(s) |
| Gender |
Female |
| Details |
all type of hearing loss girls age between 14-20 years and who are unmarried and using sign language
|
|
| ExclusionCriteria |
| Details |
age above 20 & married girls
Any H/O musculoskeletal disease , chronic disease like diabetes , hypertension and coronary-vascular disease (any other systemic disease).
Suffering from any other gynaecological or pelvic disease such as endometriosis, fibromyoma, ovarian cyst, or other related problems.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
WONG-BAKER FACES PAIN RATING SCALE
|
clinician reported measure
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
VERBAL MULTI MULTIDIMENTIONAL SCORING SYSTEM (VMSS)
|
clinician reported measure one time |
| menstrual characteristic form and school performance form |
clinician reported measure one time |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "66"
Final Enrollment numbers achieved (India)="66" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
29/10/2021 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
If the healthy women have such kind of problems during menstruation then what about those who are differently abled? lack of evidence about dysmenorrhea problems in hearing loss girls the aim of the present study is to determine the prevalence, severity of dysmenorrhea in girls with hearing loss and its impact on school performance. |