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CTRI Number  CTRI/2025/03/082412 [Registered on: 17/03/2025] Trial Registered Prospectively
Last Modified On: 10/03/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Comfort Hold Technique and Distractors]  
Study Design  Other 
Public Title of Study   How Holding a Child in different positions by parents and providing a kaleidoscope will help child sensitise less pain during procedures. 
Scientific Title of Study   A study to Assess the Effectiveness of Comfort Hold Techniques and Distracters (CHTD) to Reduce Procedural Pain and Distress in Children undergoing therapeutic procedures at Selected Hospitals of Moradabad.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Basavaraj Mudhol 
Designation  Associate Professor 
Affiliation  Teerthanker Mahaveer University 
Address  Room. No:09, Paediatric Nursing Department, Teerthanker Mahaveer College of Nursing, Teerthanker Mahaveer University, NH-09, Delhi Road, Moradabad

Moradabad
UTTAR PRADESH
244001
India 
Phone  9108623430  
Fax    
Email  mailtobasavaraj@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Basavaraj Mudhol 
Designation  Associate Professor 
Affiliation  Teerthanker Mahaveer University 
Address  Room. No:09, Paediatric Nursing Department, Teerthanker Mahaveer College of Nursing, Teerthanker Mahaveer University, NH-09, Delhi Road, Moradabad


UTTAR PRADESH
244001
India 
Phone  9108623430  
Fax    
Email  mailtobasavaraj@gmail.com  
 
Details of Contact Person
Public Query  
Name  Basavaraj Mudhol 
Designation  Associate Professor 
Affiliation  Teerthanker Mahaveer University 
Address  Room. No:09, Paediatric Nursing Department, Teerthanker Mahaveer College of Nursing, Teerthanker Mahaveer University, NH-09, Delhi Road, Moradabad


UTTAR PRADESH
244001
India 
Phone  9108623430  
Fax    
Email  mailtobasavaraj@gmail.com  
 
Source of Monetary or Material Support  
Teerthanker Mahaveer College of Nursing, Teerthanker Mahaveer Univetsity, NH-09, Delhi Road, Moradabad-244001, Uttar Pradesh  
 
Primary Sponsor  
Name  Basavaraj Mudhol 
Address  Department of Paediatric Nursing, Room No-09, Teerthanker Mahaveer College of Nursing, Teerthanker Mahaveer University, NH-09, Delhi Road, Moradabad  
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 
Yogesh Kumar  Teerthanker Mahaveer University Hospital and Research Centre  Room No: 302, Paediatric Ward, NH-09, Delhi Road
Moradabad
UTTAR PRADESH 		 9813893463

dryogesh.nursing@tmu.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Teerthanker Mahaveer University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Comfort Hold Technique and Distractors  The Comfort Hold Technique involves gentle, supportive restraint by the parents to keep a child calm and secure during medical procedures. It provides emotional reassurance and minimizes movement to ensure safety. Distractors, such as kaleidoscope is used simultaneously to divert attention and reduce anxiety. 
Comparator Agent  No Intervention  No Intervention 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  5.00 Year(s)
Gender  Both 
Details  1. Willing to participate in the study
2. Admitted in the Medical and Surgical Wards 
 
ExclusionCriteria 
Details  Children who are seriously ill. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Reduction in Procedural Pain
2. Reduction in Procedural Distress. 		 1. Immediately during the procedure.
2. Immediately during and post procedure. 
 
Secondary Outcome  
Outcome  TimePoints 
Satisfaction of the Child and Parents.  Immediately after the completion of the medical procedure. 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   21/03/2025 
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="0"
Months="3"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

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

  3. Who will be able to view these files?
    Response - Anyone

  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 made available on request, if found appropriate.

  6. For how long will this data be available start date provided 26-08-2025 and end date provided 16-02-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The research study aims to assess the effectiveness of Comfort Hold Techniques and Distracters (CHTD) in reducing procedural pain and distress in children undergoing therapeutic procedures. The study focuses on evaluating both primary outcomes, such as pain and distress levels during and after procedures, and secondary outcomes, including child and parent satisfaction, effectiveness of distraction techniques, and behavioral responses. By using a combination of comfort holds and engaging distractions, the study seeks to explore how these interventions can improve the overall experience of children during potentially distressing medical treatments. The outcomes are measured at multiple time points, including pre-procedure, during, and post-procedure, to understand both immediate and delayed effects. The findings from this study could provide valuable insights into pain management strategies for pediatric patients and help improve the quality of care in medical settings. 
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