| CTRI Number |
CTRI/2025/12/099187 [Registered on: 16/12/2025] Trial Registered Prospectively |
| Last Modified On: |
16/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Protocol development for vaginal hysterectomy |
|
Scientific Title of Study
|
Development and validation of structured preoperative exercise protocol for patients undergoing vaginal hysterectomy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHAILA BANU S |
| Designation |
POSTGRADUATE STUDENT |
| Affiliation |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
NO 1, RAMACHANDRA NAGAR,SRI RAMACHANDRA FACULTY OF PHYSIOTHERAPY, PORUR, CHENNAI
Chennai
TAMIL NADU
600116
India |
| Phone |
9150178516 |
| Fax |
|
| Email |
asanshaila2001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MS P PONMATHI |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
NO 1, RAMACHANDRA NAGAR,SRI RAMACHANDRA FACULTY OF PHYSIOTHERAPY, PORUR, CHENNAI
Chennai
TAMIL NADU
600116
India |
| Phone |
9787211229 |
| Fax |
|
| Email |
ponmathi.p@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
MS P PONMATHI |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
NO 1, RAMACHANDRA NAGAR,SRI RAMACHANDRA FACULTY OF PHYSIOTHERAPY, PORUR, CHENNAI
Chennai
TAMIL NADU
600116
India |
| Phone |
9787211229 |
| Fax |
|
| Email |
ponmathi.p@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SHAILA BANU S |
| Address |
NO 1, RAMACHANDRA NAGAR,SRI RAMACHANDRA FACULTY OF PHYSIOTHERAPY, PORUR, CHENNAI |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| MS P PONMATHI |
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY,SRI RAMACHANDRA HOSPITAL |
NO 1, RAMACHANDRA NAGAR,SRI RAMACHANDRA FACULTY OF PHYSIOTHERAPY, PORUR, CHENNAI
Chennai
TAMIL NADU |
9787211229
ponmathi.p@sriramachandra.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRIHER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N99-N99||Intraoperative and postprocedural complications and disorders of genitourinary system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
control group |
standard preoperative instructions including surgical details, postoperative complications and breathing strategies
(may include patients posted for vaginal hysterectomy in less than a week) |
| Intervention |
structured preoperative exercise protocol |
structured exercise protocol will be developed through delphi survey with the opinions of 10 experts
protocol will include atleast 3 weeks of preoperative exercises for 4 to 5 sessions per week |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
patients undergoing elective vaginal hysterectomy |
|
| ExclusionCriteria |
| Details |
Patients undergoing emergency or non-elective hysterectomy.
History of severe cardiovascular, respiratory, musculoskeletal, or neurological disorders.
Previous major pelvic surgery
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
To develop a structured preoperative exercise protocol specifically designed for patients undergoing vaginal hysterectomy through delphi survey method.
|
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of the structured preoperative exercise protocol on postoperative outcomes such as pain, mobility, urinary continence, and length of hospital stay. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
30/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/12/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
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
|
Vaginal hysterectomy is widely recognized as one of the least invasive surgical approaches for hysterectomy; however, despite its minimally invasive nature, it is still associated with several post-operative complications such as pain, reduced mobility, and urinary incontinence. While there is substantial evidence and a variety of exercise protocols available for patients undergoing abdominal hysterectomy, there remains a notable gap in research specifically addressing pre-operative exercise protocols for vaginal hysterectomy. To address this gap, the present study is designed in two phases. In the initial phase, the Delphi method will be employed to develop and validate a structured pre-operative exercise protocol with the guidance and consensus of a panel of experts. Following the validation process, the second phase will involve conducting an experimental study to evaluate the effectiveness of the developed protocol. Participants will be recruited from the Gynaecology Department of Sri Ramachandra Hospital and randomly allocated into two groups. The control group will receive standard pre-operative care as routinely practiced, while the experimental group will undergo the structured pre-operative exercise protocol developed through the Delphi method. The outcomes will then be systematically analyzed and compared between the two groups to determine the impact of the protocol on post-operative recovery and associated complications. |