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CTRI Number  CTRI/2023/08/056543 [Registered on: 16/08/2023] Trial Registered Prospectively
Last Modified On: 28/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Usefulness of cold application( ice gel pack) on pain during blood sample collection among school age children attending pediatric OPD - A Randomized Controlled Trial. 
Scientific Title of Study   Effect of cold application on pain during blood sample collection among school age children attending pediatric OPD - 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  Bandita Shee 
Designation  MSC Pediatric Nursing Student 
Affiliation  College of Nursing, JIPMER 
Address  M.Sc Nursing Pediatric Nursing Department, College of Nursing, Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER), Puducherry, India, 605006 Nightingale House, room no 327.

Pondicherry
PONDICHERRY
605006
India 
Phone  8173801039  
Fax    
Email  banditashee123@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vetriselvi P 
Designation  Assistant Professor 
Affiliation  College of Nursing, JIPMER, Puducherry 
Address  Department of Pediatric Nursing, College of Nursing,JIPMER, Puducherry, India, 605006

Pondicherry
PONDICHERRY
605006
India 
Phone  9894459434  
Fax    
Email  vetriselvijipmer1967@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vetriselvi P 
Designation  Assistant Professor 
Affiliation  College of Nursing, JIPMER, Puducherry 
Address  Department of Pediatric Nursing, College of Nursing,JIPMER, Puducherry, India, 605006

Pondicherry
PONDICHERRY
605006
India 
Phone  9894459434  
Fax    
Email  vetriselvijipmer1967@gmail.com  
 
Source of Monetary or Material Support  
INTRAMURAL RESEARCH FUND COMMITTEE, Jawaharlal Institute OF Post Graduate Medical Education & Research, PUDUCHERRY-605006 
 
Primary Sponsor  
Name  JIPMER 
Address  INTRAMURAL RESEARCH FUND COMMITTEE ,JIPMER,PUDUCHERRY-605006 
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 Vetriselvi P  Jawaharlal Institute of Post Graduate Medical Education and Research   Pediatric OPD, Ground Floor, Women and Child Hospital, Puducherry- 605006. India
Pondicherry
PONDICHERRY 		 9894459434

vetriselvijipmer1967@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Nursing Courses(Human Studies)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  cold application  : The investigator will apply ice gel pack over the selected needle insertion site for 20 seconds prior to needle insertion and stopwatch will be used to perform an alarm sound at the end of the time. • After the time finished, the ice gel pack will be removed and blood sample will be collected. Soon after the sample collection pain score will be assessed by using Wong baker faces pain scale.  
Comparator Agent  Nil  Blood sample collection will be done in a routine manner and pain will be assessed by using Wong baker faces pain scale. 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1. School age group children of (6-12) years old undergoing blood sample collection procedure. 
 
ExclusionCriteria 
Details  1.Child with cognitive impairment.
2.Child with peripheral vascular disease.
3.Child have disease associated with impaired circulation.
4.Child have muscle spasm.
 
 
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 
To assess the effect of cold application on pain during blood sample collection among school age children attending pediatric OPD.  20 seconds 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="316"
Sample Size from India="316" 
Final Enrollment numbers achieved (Total)= "316"
Final Enrollment numbers achieved (India)="316" 
Phase of Trial
Modification(s)  		 Phase 1/ Phase 2 
Date of First Enrollment (India)   15/09/2023 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This study is a randomized controlled trial to assess the effect of cold application on pain during blood sample collection among school age children attending pediatric OPD. According to the sequence order the subject will be allocate to the experiment and control group . Outcome assessor will be blinded in this study.  Data on socio demographic and clinical characteristics will be collected from medical record. In intervention group Prior to blood sample collection the investigator will apply ice gel pack over the chosen insertion site for 20 seconds. After the procedure pain level will be assessed by Wong baker face pain scale.  Differences in pain score of between 2 group will be compared . 
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