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CTRI Number  CTRI/2024/09/073472 [Registered on: 05/09/2024] Trial Registered Prospectively
Last Modified On: 03/09/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of video-assisted versus conventional patient education on anxiety, kinesiophobia & patient satisfaction in patients post open abdominal surgery 
Scientific Title of Study   Comparison of the effects of video-assisted versus conventional patient education on kinesiophobia,patient satisfaction and anxiety in patients post open abdominal surgery: Open-Labelled 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  Shruti Nair 
Designation  Associate Professor 
Affiliation  MGM College of Physiotherapy 
Address  Department of Cardiovascular and Respiratory Physiotherapy,MGM College of Physiotherapy, First floor,Plot-46, Sector 30 A, Vashi, Navi Mumbai

Thane
MAHARASHTRA
400705
India 
Phone  9769323125  
Fax    
Email  shrutinair2008@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Shruti Nair 
Designation  Associate Professor 
Affiliation  MGM College of Physiotherapy 
Address  Department of Cardiovascular and Respiratory Physiotherapy,MGM College of Physiotherapy, First floor,Plot-46, Sector 30 A, Vashi, Navi Mumbai

Thane
MAHARASHTRA
400705
India 
Phone  9769323125  
Fax    
Email  shrutinair2008@gmail.com  
 
Details of Contact Person
Public Query  
Name  Lakshman Iyer 
Designation  Assistant Professor 
Affiliation  MGM College of Physiotherapy 
Address  Department of Cardiovascular and Respiratory Physiotherapy,MGM College of Physiotherapy, First floor,Plot-46, Sector 30 A, Vashi, Navi Mumbai

Thane
MAHARASHTRA
400705
India 
Phone  9930849135  
Fax    
Email  krishiyer1996@gmail.com  
 
Source of Monetary or Material Support  
Infrastural support provided by MGM College of Physiotherapy, MGM Hospital, Navi Mumbai 
 
Primary Sponsor  
Name  MGM College of Physiotherapy 
Address  MGM College of Physiotherapy, Scetor 30 A, Vashi, Navi Mumbai 400705 
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 
Dr Shruti Nair  M.G.M Hospital  Plot No. 1 & 2, Sector-1, NH-4 Junction, Mumbai - Pune Hwy, Kamothe, Navi Mumbai,
Raigarh
MAHARASHTRA 		 9769323125

shrutinair2008@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MGM Institutional Research Review Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K918||Other intraoperative and postprocedural complications and disorders of digestive system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional patient education  Patients in the control group received conventional patient education along with standard physiotherapy care. Conventional patient education sessions covered various aspects of postoperative care, including pain management, splinting, dos and donts, drain care, deep vein thrombosis (DVT) and pressure sore prevention, diaphragmatic breathing, thoracic expansion, incentive spirometry, graded mobilization, and safe transfers. Following patient education, standard physical therapy treatment commenced with two sessions each day. Every session began with diaphragmatic exercises (4 repetitions across 2 sets) and progressed to thoracic expansion exercises (6 repetitions across 2 sets). After that, the patients performed incentive spirometry exercise. patients afterwards performed safe transfers to ensure that they could move between positions in a comfortable and secure method. Finally, the sessions concluded with graded mobilization activities tailored to individual capabilities and postoperative needs. 
Intervention  Video-assisted patient education  Patients in the intervention group received standard physiotherapy care in addition to videos that presented patient education. The video content was methodically developed to provide comprehensive postoperative care and rehabilitation guidance from a physiotherapy perspective. The videos were aimed at encouraging maximum healing and functional restoration while addressing multiple aspects of recovery after open abdominal surgery. Following the video sessions, tailored physiotherapy exercises comparable to control group were administered, complementing the educational content. Daily two sessions were delivered with each session ranging from 30-45 minutes. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  59.00 Year(s)
Gender  Both 
Details  Patients recently undergoing open abdominal surgery who were referred for physiotherapy and provided informed consent prior to participation.  
 
ExclusionCriteria 
Details  Patients who underwent laparoscopic surgery, those who were hemodynamically unstable, and individuals with pre-existing neurological or cardiovascular conditions making exercise during physiotherapy sessions unsuitable, patients with a poor Montreal Cognitive Assessment score (less than 10) and those who refused to participate were also excluded from the study 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
(1)Anxiety:Beck Anxiety Inventory (BAI)
(2)Kinesiophobia:The Tampa Scale for Kinesiophobia (TSK)
(3)Patient satisfaction: Questionnaire 		 At baseline, post 6 days 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  NA 
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
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)   16/09/2024 
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 Yet Recruiting 
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
  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

  3. 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.

  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 (Others) -  Data will be shared on email request to PI at shrutinair2008@gmail.com

  6. For how long will this data be available start date provided 28-11-2024 and end date provided 28-11-2025?
    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 - None
Brief Summary   Evidence indicates that conventional verbal and written treatment information frequently lacks clarity and may only be partially comprehended by patients. Simulation videos offer an effective means of enhancing patient comprehension and satisfaction, simplifying complex concepts and improving engagement in healthcare education programs.Therefore, the research question for this randomized trial was: Is video-assisted patient education a better approach than conventional patient education in reducing anxiety, kinesiophobia, and enhancing patient satisfaction with physiotherapy post open abdominal surgery? 
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