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CTRI Number  CTRI/2025/11/097330 [Registered on: 13/11/2025] Trial Registered Prospectively
Last Modified On: 11/11/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Study on the HEAL Nursing Protocol to Support Recovery After Abdominal Surgery 
Scientific Title of Study   Development and Validation of the HEAL Monitoring Protocol as a Standardized Nursing Checklist for Postoperative Recovery and Complication Surveillance in Abdominal Surgery Patients: A Randomized Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mr JAMES RAJ K  
Designation  Assistant Professor  
Affiliation  College of Nursing sciences, Dayananda Sagar University, 
Address  Room No. HS110, College of Nursing sciences, Dayananda Sagar University, Devarakaggalahalli, Kanagapura Road, Bangalore South ,Karnataka 562112, India.

Bangalore Rural
KARNATAKA
562112
India 
Phone  9500482944  
Fax    
Email  jamj36668@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mr JAMES RAJ K  
Designation  Assistant Professor  
Affiliation  College of Nursing sciences, Dayananda Sagar University, 
Address  Room No. HS110, College of Nursing sciences, Dayananda Sagar University, Devarakaggalahalli, Kanagapura Road, Bangalore South ,Karnataka 562112, India.

Bangalore Rural
KARNATAKA
562112
India 
Phone  9500482944  
Fax    
Email  jamj36668@gmail.com  
 
Details of Contact Person
Public Query  
Name  Mr JAMES RAJ K  
Designation  Assistant Professor  
Affiliation  College of Nursing sciences, Dayananda Sagar University, 
Address  Room No. HS110, College of Nursing sciences, Dayananda Sagar University, Devarakaggalahalli, Kanagapura Road, Bangalore South ,Karnataka 562112, India.

Bangalore Rural
KARNATAKA
562112
India 
Phone  9500482944  
Fax    
Email  jamj36668@gmail.com  
 
Source of Monetary or Material Support  
Dr.Chandramma Dayananda Sagar Institute of Medical Education and Research (CDSIMER), Deverakaggalahalli, Kanakapura Road,Bengaluru South District, Karnataka - 562 112, India 
 
Primary Sponsor  
Name  Mr JAMES RAJ K 
Address  College of Nursing sciences, Dayananda Sagar University, Deverakaggalahalli, Kanakapura Road,Bengaluru South District, Karnataka - 562 112, India  
Type of Sponsor  Other [self] 
 
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 Mehak Manzoor  CDSIMER (Dr.Chandramma Dayananda Sagar Institute of medical Education and Research)  Room No: SHS002 Deverakaggalahalli, Kanakapura Road,Bengaluru South District, Karnataka - 562 112, India
Bangalore Rural
KARNATAKA 		 9500482944

mehakmanzoor-nsg@dsu.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr. Chandramma Dayananda Sagar Institute of Medical and Research (CDSIMER)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K929||Disease of digestive system, unspecified, (2) ICD-10 Condition: K918||Other intraoperative and postprocedural complications and disorders of digestive system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  HEAL Protocol  A structured nursing care protocol comprising the following components: Hydration monitoring and encouragement Early mobilization within 24 hours post-surgery Active breathing exercises (incentive spirometry, deep breathing) Limb exercises (passive and active range of motion) Administered by trained nursing staff post-abdominal surgery until discharge or 5 days, whichever is earlier.  
Comparator Agent  Routine Postoperative Nursing Care  patients will receive standard postoperative nursing care and documentation, including vital signs charting, intake-output monitoring, medication chart, and physiotherapy progress notes. No HEAL checklist or composite scoring will be used. Monitoring and documentation will follow the hospital’s existing nursing and medical practices. Outcome measures (length of hospital stay, complication rates, mobilization milestones) will be collected by a blinded assessor through medical record review. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients aged 18 to 65 years undergoing elective abdominal surgery

Both male and female patients

Hemodynamically stable postoperatively

Able to follow instructions and give informed consent

Admitted for a minimum of 5 days postoperative recovery 
 
ExclusionCriteria 
Details  Emergency abdominal surgeries

Patients with neurological deficits, impaired cognition, or altered sensorium

Patients requiring ICU care or mechanical ventilation postoperatively

Patients with orthopedic limitations restricting mobility

Unwilling or unable to participate in postoperative physiotherapy or exercise routines

Patients with pre-existing respiratory or cardiac complications contraindicating active breathing or mobilization 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Length of hospital stay (in days) – assessed from day of surgery to discharge.  From day of surgery to day of discharge (maximum up to 10 postoperative days) 
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of postoperative complications (hydration, pulmonary, VTE)  Within 10 postoperative days or until discharge, whichever is earlier 
 
Target Sample Size   Total Sample Size="106"
Sample Size from India="106" 
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   Phase 1 
Date of First Enrollment (India)   15/12/2027 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  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 - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [jamj36668@gmail.com].

  6. For how long will this data be available start date provided 01-08-2026 and end date provided 01-08-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This randomized controlled trial aims to develop and validate the HEAL Monitoring Protocol, a structured nurse led postoperative checklist for abdominal surgery patients. The protocol focuses on four domains: Hydration, Early Mobilization, Active Breathing, and Limb Monitoring. The intervention group will receive daily HEAL monitoring from postoperative day one to day five, while the control group will receive routine postoperative care and documentation. The study will compare recovery outcomes including length of hospital stay and incidence of postoperative complications. The HEAL protocol is designed to provide standardized nursing assessment, improve early detection of risks, and promote faster recovery among patients undergoing abdominal surgery. 
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