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CTRI Number  CTRI/2025/02/080125 [Registered on: 07/02/2025] Trial Registered Prospectively
Last Modified On: 14/06/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) 
Study Design  Other 
Public Title of Study   AN EXPERIMENTAL STUDY TO ASSESS THE EFFECTIVENESS OF DISTRACTION TECHNIQUE VS LOCAL COLD APPLICATION ON LEVEL OF PAIN,FEAR & BEHAVIOURAL DISTRESS DURING INTRAVENOUS PROCEDURE AMONG CHILDREN AT SELECTED HOSPITALS IN CHENNAI 
Scientific Title of Study   AN EXPERIMENTAL STUDY TO ASSESS THE EFFECTIVENESS OF DISTRACTION TECHNIQUE VS LOCAL COLD APPLICATION ON LEVEL OF PAIN,FEAR & BEHAVIOURAL DISTRESS DURING INTRAVENOUS PROCEDURE AMONG CHILDREN AT SELECTED HOSPITALS IN CHENNAI 
Trial Acronym  Distraction technique and local cold application 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Priya Sengupta 
Designation  Lecturer 
Affiliation  Bhaarath college of Nursing 
Address  Jagadambha fancy store opposite to Bharath institute of higher education and research selaiyur chennai-600073
Bhaarath college of Nursing Bharath Institute of Higher Education & Research
Kancheepuram
TAMIL NADU
600073
India 
Phone  6361924528  
Fax    
Email  piyagupta697@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Priya Sengupta 
Designation  Lecturer 
Affiliation  Bhaarath college of Nursing 
Address  Jagadambha fancy store opposite to Bharath institute of higher education and research selaiyur chennai-600073
Bhaarath college of Nursing Bharath Institute of Higher Education & Research
Kancheepuram
TAMIL NADU
600073
India 
Phone  6361924528  
Fax    
Email  priya@bnch.in  
 
Details of Contact Person
Public Query
 
Name  Priya Sengupta 
Designation  Lecturer 
Affiliation  Bhaarath college of Nursing 
Address  Jagadambha fancy store opposite to Bharath institute of higher education and research selaiyur chennai-600073
Bhaarath college of Nursing Bharath Institute of Higher Education & Research
Kancheepuram
TAMIL NADU
600073
India 
Phone  6361924528  
Fax    
Email  piyagupta697@gmail.com  
 
Source of Monetary or Material Support  
Bhaarath Medical College And Hospital 
 
Primary Sponsor  
Name  Priya Sengupta 
Address  Bhaarath College Of Nursing, Bharath Institute of Higher Education and Research, Selaiyur, Chennai-600073 
Type of Sponsor  Private hospital/clinic 
 
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 
BMCH management  bharath medical college and hospital  Selaiyur, Chennai 600073
Kancheepuram
TAMIL NADU 
91 44-61116222

office@bmch.ac.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
bharath institutional ethical committee  Approved 
bharath institutional ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Awaited 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: U07-U07||Provisional assignment of new diseases of uncertain aetiology or emergency use (U00-U49),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  1.MALE AND FEMALE CHILD IN BETWEEN 3TO 6 YEARS AGE GROUPS ONLY INCLUDED INCLUSION CRITERIA, WHO ARE RECEIVING INTRAVENOUS THERAPY
2.WHO ARE WILLING TO PARTICIPATE IN THAT STUDY
3. WHO ARE ADMITTED IN PEDIATRIC EMERGENCY,MEDICINE OUT PATIENT DEPARTMENT, PEDIATRIC GENERAL WARD AND PEDIATRIC INTENSIVE CARE UNIT 
 
ExclusionCriteria 
Details  Exclusion criteria for sampling refers to children:
1. Children those who are critically ill.
2. Children those who are mentally challenged children.
3. Children with skin abrasions or any type of skin lesions at procedure site.
4. Children who are admitted with surgical condition.

 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
comparison between distraction technique vs local cold application on level ofpain, fear and behavioural distress children receiving intravenous therapy  6-9months 
 
Secondary Outcome  
Outcome  TimePoints 
to reduce the level of pain, fear & behavioural distress among children receiving intravenous procedure  6-9 months 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
Final Enrollment numbers achieved (Total)= "180"
Final Enrollment numbers achieved (India)="180" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   28/02/2025 
Date of Study Completion (India) 12/06/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 12/06/2025 
Estimated Duration of Trial   Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
ONE SCOPUS JOURNAL OBSTETRICS AND GYNAECOLOGY FORUM AND ONE WEB OF SCIENCE LIBERTY JOURNAL PUBLISHED 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

A distraction strategy is an activity that takes the children’s mind off the current emotions. Instead of putting the energy into worries and increasing distress, this technique can focus on other things instead to give our mind and body time to calm down. Cold application relieves pain and prevents complications, by slowing down the ability of pain fibres to transmit pain impulses, decreasing edema and inflammation. Cold application prior to the procedure helps in reducing physical distress and making the child comfortable.

 

    

     Local cold applications provide transient anaesthesia to the skin within moments of application. Distraction are chosen as the primary intervention because it provides a simple approach in reducing pain and fear that has been shown to be effective in a number of settings since it is easy, economical. Observational assessment is an important component of a comprehensive evaluation of children’s procedural pain. 

 
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