| CTRI Number |
CTRI/2023/06/054462 [Registered on: 27/06/2023] Trial Registered Prospectively |
| Last Modified On: |
26/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Impact of menstrual symptoms on practicing physiotherapists. |
|
Scientific Title of Study
|
A corelational study to assess the severity of menstrual symptoms affecting the work life in clinical physiotherapist |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sai Keerthana Setty |
| Designation |
PG student |
| Affiliation |
College of physiotherapy,Dayanada Sagar University |
| Address |
#8, flat no :002 ID park view appartmnet,3rd main road, second floor, AGS layout ,arehalli, Benaluru
Bangalore
KARNATAKA
560061
India |
| Phone |
7975026596 |
| Fax |
|
| Email |
saikeerthanasetty@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Srihari Sharma K N |
| Designation |
Professor |
| Affiliation |
College of physiotherapy,Dayanada Sagar University |
| Address |
Shavige Maleshwara hills,1st stage ,Kumarswamy layout
Bengaluru 560078
Bangalore
KARNATAKA
560111
India |
| Phone |
0886040520 |
| Fax |
|
| Email |
srihari-physio@dsu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Srihari Sharma K N |
| Designation |
Associate Professor |
| Affiliation |
College of physiotherapy,Dayanada Sagar University |
| Address |
Shavige Maleshwara hills,1st stage ,Kumarswamy layout
Bengaluru 560078
Bangalore
KARNATAKA
560111
India |
| Phone |
9886040520 |
| Fax |
|
| Email |
srihari-physio@dsu.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
College of physiotherapy Dayanada Sagar University |
| Address |
Shavige Malleshwara hills,Kumarswamy Layout
Bengaluru 560111 |
| Type of Sponsor |
Other [Private University] |
|
|
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 |
| sai keerthana setty |
College of physiotherapy, Dayananda sagar university |
Department of physiotherapy shavige malleshwara hills ,kumarswamy layout
Bangalore
KARNATAKA |
7975026596
saikeerthanasetty@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dayananda Sagar University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Menstruation |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
38.00 Year(s) |
| Gender |
Female |
| Details |
1)Clinical physiotherapist working more than 5 hours per day.
2)Female who experience symptomatic menstrual period
3)Age 25-38 years
4)Clinical work experience - more than 2 years
|
|
| ExclusionCriteria |
| Details |
1)Menstrual disorders including PCOD,PCOS, Dysmennorhea etc
2)People not willing to participate
3)Other co existing medical conditions that would interfere with menstrual cycle
4)Patients with Endometriosis and Fibroids
Patients undergone gynaecological surgeries like hysterectomy
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| work productvity (iPCQ) |
iPCQ wil be given in to the population during the initial assessment
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| severrity of menstrual symptoms (MSQ) |
MSQ will be given to the population during the initial assessmet
|
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
10/07/2023 |
| 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="3"
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
|
We are recruiting the participants according to inclusion criteria, explaining the procedure and taking the consent from them. Once the particpants are ready to participate we give them the questionnarie to fill. The outcome measures used are Menstrual Symptoms questionnarie and iPCQ. Questions should be explained to them. Once the data of hundred samples are collected we need to analyse the data and co- relate them between two objectives and come into conclusion. |