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CTRI Number  CTRI/2024/04/066140 [Registered on: 23/04/2024] Trial Registered Prospectively
Last Modified On: 22/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Electrical modality and exercise reduced pain and improve quality of life after gynaecology surgery  
Scientific Title of Study   Effectiveness of transcutaneous electrical nerve stimulation in addition to routine physiotherapy care on quality of life and pain after abdominal hysterectomy: A Randomized Controlled 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  PRIYADHARSHINI R 
Designation  Master of Physiotherapy  
Affiliation  Mother Theresa Post Graduate and Research Institute of Health science (Government of Pondicherry) 
Address  Obstetrics and Gynaecology physiotherapy lab, second floor , Mother Teresa Post Graduate and Research Institute of Health Sciences, Indir nagar, Gorimedu.
Indira Gandhi Medical Collage and Research Institute, Vazhudavur Road, Kathirkamam.
Pondicherry
PONDICHERRY
605006
India 
Phone  7094566136  
Fax    
Email  sugunaravipriya@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Beulah Jebakani .D  
Designation  HOD and Associate Professor Obstetrics and Gynaecology physiotherapy 
Affiliation  Mother Theresa Post Graduate and Research Institute of Health science (Government of Pondicherry) 
Address  Indira Nagar, Gorimedu, Priyadarshini nagar, Puducherry
Indira Nagar, Gorimedu, Priyadarshini nagar, Puducherry
Pondicherry
PONDICHERRY
605006
India 
Phone  9585525141  
Fax    
Email  beulahjebakani@mtpgrihs.ac.in  
 
Details of Contact Person
Public Query  
Name  PRIYADHARSHINI R 
Designation  Master of Physiotherapy  
Affiliation  Mother Theresa Post Graduate and Research Institute of Health science (Government of Pondicherry) 
Address  Obstetrics and Gynaecology Physiotherapy lab, second floor, Mother Theresa Post Graduate and Research Institute of Health Sciences, Indira Nagar, Gorimedu,
Indira Gandhi Medical Collage and Research Institute, Kathirkamam Pondicherry Room no.17 Physiotherapy department OPD
Pondicherry
PONDICHERRY
605006
India 
Phone  7094566136  
Fax    
Email  sugunaravipriya@gmail.com  
 
Source of Monetary or Material Support  
Indira Gandhi Medical College and Research Institute Kathirkamam Pondicherry  
 
Primary Sponsor  
Name  Priyadharshini R 
Address  Department of Physiotherapy(OBG), Mother Theresa Post Graduate and and Research Institute of Health Science(Government of Pondicherry), Pondicherry.  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrPriyadharshini R  Indira Gandhi Medical College and Research Institute   Kathirgamam Pondycherry Department of Obstetrics and Gynaecology gynaecology ward unit I
Pondicherry
PONDICHERRY 		 7094566136

sugunaravipriya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee (Human studies) Indira Gandhi Medical College and Research Institute  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N998||Other intraoperative and postprocedural complications and disorders of genitourinary system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Physiotherapy care  Physiotherapy care Breathing exercises-7 repetition huffing techniques-5 repetition Circulatory exercises-10 repetition Knee rolling-10 repetition log rolling- 5 repetition patient made to sit2 repetition(each time 2 minutes maintain this position) Abdominal exercises-10 repetition Pelvic tilt-10 repetition Getting in and out of the bed-2 repetition ( each time 2 minutes maintain this position) Pelvic floor exercises-10 repetition and mobilization around the ward outside the ward 10 minutes and stair climbing(4 steps) 5 minutes. total duration 30 minutes. Treatment duration totally 6 days.  
Comparator Agent  Transcutaneous Electrical Nerve Stimulation in addition Physiotherapy care   TENS Mode conventional TENS Frequency 100to 150 Hz Intensity 12 to 30 mA Duration 30 minutes Placement of Electrodes 5 cm above to the incision line. Physiotherapy care Breathing exercises-7 repetition huffing techniques-5 repetition Circulatory exercises-10 repetition Knee rolling-10 repetition log rolling- 5 repetition patient made to sit2 repetition(each time 2 minutes maintain this position) Abdominal exercises-10 repetition Pelvic tilt-10 repetition Getting in and out of the bed-2 repetition ( each time 2 minutes maintain this position) Pelvic floor exercises-10 repetition and mobilization around the ward outside the ward 10 minutes and stair climbing(4 steps) 5 minutes. Total duration 1 hour 30minutes for TENS 30 minutes exercise. Treatment duration totally 6 days  
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  1) Women undergoing Abdominal hysterectomy in OG I unit OT days (Wednesday & Saturday) in their postoperative days 1 to 6.
2) Willing to participate in the study.
3) Pain score ≥3 measured by the Visual analogue scale (VAS) / pain of 5 or greater on a 0 to 10 numerical rating scale (NRS) or moderate on a verbal descriptive scale were approached to participate in the study 
 
ExclusionCriteria 
Details  1) Preoperative opioid use (regular use of opioid analgesics for more than 2 weeks during the 6 month period before surgery as determined by patient interview).
2) Inability to cognitively follow the required directions.
3) Participator’s inability to fully complete with study protocol due to uncontrolled epilepsy, Renal failure, Cardiopulmonary disorders, Central nervous system disease (or) psychosis.
4) Coagulation disorders.
5) Any sign of sepsis.
6) Any specialties surgery of the head (brain, face), neck ( Thyroid, throat) Thoracic (cardio , pulmonary) , breast, Orthopaedic including amputations (or) reset of amputation (phantom limb pain) , (or) Plastic surgery (Liposuction) were not considered.
7) Any skin allergy(dermatological lesions affecting electrode placement). 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Abdominal surgery impact scale   Outcome taken from post operative day 1 and post operative day 6 
 
Secondary Outcome  
Outcome  TimePoints 
Visual analogue scale   Post operative day 1 before & after intervention
Post operative day 6 after intervention 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" 
Phase of Trial   N/A 
Date of First Enrollment (India)   23/05/2024 
Date of Study Completion (India) 21/11/2024 
Date of First Enrollment (Global)  23/05/2024 
Date of Study Completion (Global) 21/11/2024 
Estimated Duration of Trial   Years="0"
Months="6"
Days="6" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Data are available indefinitely at (Link to be included sugunaravipriya@gmail.com).

  6. For how long will this data be available start date provided 18-03-2024 and end date provided 31-12-2024?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - sugunaravipriya@gmail.com
Brief Summary
Modification(s)  

Effectiveness of Transcutaneous Electrical Nerve Stimulation in addition to Routine Physiotherapy care on Quality of Life and Pain after Abdominal hysterectomy: A Randomized Controlled Trial.

After the Abdominal hysterectomy the incisional pain is more ,it causes the negative impact of the patient physical and mental health. Post operative pain reduce the Quality of Life. The preferred post operative pain is opioid usage. However due to opioid- related side effects, including emesis and itiching , opioid use can lead to poor Quality of Life ,Thus, contemporary pain therapy aims to reduce opioid usage via multimodal technique. includes Breathing exercises, Coughing techniques, Circulatory exercises, Knee rolling, log rolling, patient made to sit, Abdominal exercises, Pelvic tilting, Getting in and out of the bed, Pelvic floor exercises and mobilization around the ward, outside the ward and stair climbing, All the exercises were performed. Transcutaneous Electrical Nerve Stimulation is non invasive, non pharmacological and low frequency electrotherapy technique has been used for pain after Abdominal hysterectomy. There is a lack of awareness about Transcutaneous Electrical Nerve Stimulation (TENS) usage in addition to Routine physiotherapy care. There is a urgent need for research on the Effectiveness of Transcutaneous Electrical Nerve Stimulation in addition Routine Physiotherapy care improve Quality of Life and reduce Pain after Abdominal hysterectomy. Outcome measure used for Abdominal Surgery Impact Scale (ASIS), and Visual Analogue Scale (VAS)

 
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