| CTRI Number |
CTRI/2025/09/094036 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
01/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA)
Other (Specify) [Gynaecological Physiotherapy] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A special treatment to help women with difficulty during sex due to a tight pelvic floor and moderate vaginismus. |
|
Scientific Title of Study
|
Efficacy of Invasive Pelvic Floor Rehabilitation versus Exercise Training in Vaginismus patients with grade -2 hypertonus Pelvic floor muscles- A randomized control Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Reema Rasotra |
| Designation |
Assistant Professor |
| Affiliation |
Lovely Professional University |
| Address |
Lovely school of allied medical sciences,Department of Physiotherapy,Room no. 3-105,Campus physiotherapy OPD,Lovely Professional University,Phagwara
Lovely school of allied medical sciences,Department of Physiotherapy,Room no. 3-105,Campus physiotherapy OPD,Lovely Professional University,Phagwara
Kapurthala
PUNJAB
144401
India |
| Phone |
9888706015 |
| Fax |
0 |
| Email |
rasotra1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Reema Rasotra |
| Designation |
Assistant Professor |
| Affiliation |
Assistant Professor |
| Address |
Lovely Professional University, Jalandhar Phagwara Grand Trunk Road, Phagwara
Kapurthala
PUNJAB
144401
India |
| Phone |
9888706015 |
| Fax |
0 |
| Email |
rasotra1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Varun kalia |
| Designation |
Assistant Professor |
| Affiliation |
Lovely Professional University |
| Address |
Lovely school of Allied medical science,Department of Physiotherapy,Room no. 3-105,Campus Physiotherapy OPD,Lovely Professional University,Phagwara
Lovely school of Allied medical science,Department of Physiotherapy,Room no. 3-105,Campus Physiotherapy OPD,Lovely Professional University,Phagwara
Kapurthala
PUNJAB
144401
India |
| Phone |
8360374990 |
| Fax |
0 |
| Email |
varun.26576@lpu.in |
|
|
Source of Monetary or Material Support
|
| Lovely Professional University,Phagwara |
|
|
Primary Sponsor
|
| Name |
Lovely Professional University |
| Address |
Lovely Professional University,Jalandhar-Delhi GT Road,NH1,Phagwara 144401 |
| 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 |
| DrSuresh Mani |
Lovely Professional University |
Jalandhar Phagwara Grand Trunk Road, Phagwara, Punjab, India. 144401
Kapurthala
PUNJAB |
9878331006
0
suresh.22351@lpu.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical commitee-Lovely Professional University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O998||Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Exercise training for lower limb |
stretching exercises of lower limb such as Integrated Stretching Exercise-Hamstring, Integrated stretching exercise-tensor fasciae latae, Integrated stretching of Piriformis, Integrated stretching of Hip adductors, Happy Baby pose, Integrated deep frog stretch, Integrated half pigeon stretch, Integrated reclined bound stretch, Deep side lunge stretch ,Partial bridge stretch ,Integrated lumbopelvic stretch,Integrated warrier stretch ,Integrated prayers stretch ,Deep Frog Stretch etc |
| Comparator Agent |
Invasive pelvic floor Treatment |
Phase A-Beginners Phase: - In this phase vaginal dilator with minimal width has to be chosen and lubricated with ultrasonic gel .Then it has to be inserted inside the vagina of the female and gentle to and fro motions with that has to be performed with 15-20 repetitions.
Phase B-Intermediate Phase:- In this phase vaginal dilator with minimum to moderate width has to selected and inserted inside the vagina and gentle to and fro motions has to performed with 15-20 repetitions.
Phase C-Functional Phase: - In this phase vaginal dilator with maximum width has to be lubricated and inserted inside the vagina. Along with this thrusting activities has to be performed with the dilator with 15-20 repetitions
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
(a)To be married for at least 6 months and be expected to be sexually active;
(b)To be healthy, with no major mental or medical conditions
(c)To be literate to understand and complete all the questionnaires independently and
(d)Not receiving any psychiatric or pharmacological treatments in the last 3 months.
(e)Diagnosed as vaginismus patient by gynecologist
|
|
| ExclusionCriteria |
| Details |
Lack of consent
During menstruation
Females having ovarian ,cervix cancer
Females having PCOD problems
Females who are Drug Addicted
Females who had a failure to test tube babies
Females having vaginal warts
Females having STD such as HIV
Females having Herpes disease, Hepatitis
Any skin Infection
Female taking contraceptive pills
Pregnancy
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Numerical pain rating scale |
Base Line, 4th Week, and 8th Week (Post Intervention) |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
15/09/2025 |
| 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="2"
Months="6"
Days="30" |
|
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [reema.24404@lpu.co.in].
- For how long will this data be available start date provided 02-01-2027 and end date provided 02-12-2030?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Objectives of the study To determine the efficacy of Invasive Pelvic Floor Rehabilitation in Vaginismus patients with grade -2 hyper tonus Pelvic floor muscles. To determine the efficacy of Intra-vaginal pelvic floor rehabilitation on quality of life and sexual quality of life in patient with grade -2 vaginismus. To determine the efficacy of exercise training on quality of life and sexual quality of life in patient with grade -2 vaginismus. |