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CTRI Number  CTRI/2022/02/040328 [Registered on: 15/02/2022] Trial Registered Prospectively
Last Modified On: 14/02/2022
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   Effect of skin tap method on pain during Hepatitis-B vaccination for newly born babies. 
Scientific Title of Study   Effect of skin tap technique on pain during Hepatitis B Vaccination among newborns. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ChitraA 
Designation  M.sc., Pediatric Nursing student 
Affiliation  College of Nursing, JIPMER. 
Address  Jawaharlal Institute of Post Gratuate Medical Education and Research, college of Nursing , Puducherry
Jawaharlal Institute of Post Gratuate Medical Education and Research, college of Nursing , Puducherry
Pondicherry
PONDICHERRY
605006
India 
Phone  7845486842  
Fax    
Email  chitrasarumugam@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrPVetriselvi 
Designation  Assistant Professor 
Affiliation  College of Nursing, JIPMER. 
Address  Jawaharlal Institute of Post Gratuate Medical Education and Research, college of Nursing , Puducherry
Jawaharlal Institute of Post Gratuate Medical Education and Research, college of Nursing , Puducherry
Pondicherry
PONDICHERRY
605006
India 
Phone  9894459434  
Fax    
Email  vetriselvijipmer1967@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrPVetriselvi 
Designation  Assistant Professor 
Affiliation  College of Nursing, JIPMER. 
Address  Jawaharlal Institute of Post Gratuate Medical Education and Research, college of Nursing , Puducherry
Jawaharlal Institute of Post Gratuate Medical Education and Research, college of Nursing , Puducherry
Pondicherry
PONDICHERRY
605006
India 
Phone  9894459434  
Fax    
Email  vetriselvijipmer1967@gmail.com  
 
Source of Monetary or Material Support  
JAWAHARLAL INSTITUTE OF POST GRADUATE MEDICAL EDUCATION AND RESEARCH 
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [NIL] 
 
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 
Chitra A  Jawaharlal Institute of Post Graduate Medical Education and Research,   Department of pediatric nursing First floor College of nursing Jawaharlal Institute of Post Graduate Medical Education and Research
Pondicherry
PONDICHERRY 		 7845486842

chitrasarumugam@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee for Human Studies ,JIPMER.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Hepatitis-B vaccination, Newborn 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  In the control group, Hepatitis-B vaccination will be given in a routine manner and the pain score will be assess by using the Neonatal Infant Pain Scale. 
Intervention  Skin tap  In the experimental group, newborns will be allowed to lie on the bed and the investigator will tap the injection site (Vastuslateralis) with Palmer aspect of fingers 16 times before insertion of the needle and continued for 3 times during the injection, and pain score will be asses by Neonatal Infant Pain scale.  
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  Newborn babies who are receiving Hepatitis-B vaccination and have not received any intramuscular injection for the last 1 hour 
 
ExclusionCriteria 
Details  Babies who are crying continuously before vaccination.
Sick infants.
Babies with birth asphyxia or congenital abnormalities.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the effect of skin tap technique on pain during Hepatitis-B vaccination among Newborns.  6 Week. 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   24/02/2022 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
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 -  Statistical Analysis Plan
    Response -  Analytic Code

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

  4. For what types of analyses will this data be available?
    Response (Others) -  Deidentified patient data will be shared during publication of the study.

  5. By what mechanism will data be made available?
    Response (Others) -  Deidentified patient data like demographic data and outcome details.

  6. For how long will this data be available start date provided 30-12-2022 and end date provided 30-12-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study is a randomized controlled trial to know the effectiveness of the skin tap technique on pain during Hepatitis-B vaccination among Newborns. Clinical characteristics of newborns will be collected from the case sheet. According to sequence order, The subject will be allocated to the experimental group and control group.  The experimental group will receive skin tap during Hepatitis-B vaccination and pain level will be assessed at the same time by using the Neonatal Infant Pain Scale.  The pain level of subjects in the control group will be assessed using the same pain scale during hepatitis B vaccination without giving skin tap. Difference in  the level of pain will be compared between two groups. 
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