| CTRI Number |
CTRI/2025/10/095704 [Registered on: 08/10/2025] Trial Registered Prospectively |
| Last Modified On: |
07/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Effect of shot blocker] |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Shot Blocker on Reducing Pain during Immunization in Infants at AIIMS Jodhpur |
|
Scientific Title of Study
|
Effect of Shot Blocker on Pain during Immunization among Infants at AIIMS Jodhpur: A Quasi-Experimental Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Suryapriya Nellaikumar Pandaram |
| Designation |
M.Sc nursing student |
| Affiliation |
AIIMS, Jodhpur |
| Address |
Department of Pediatrics
All India Institute of Medical Sciences (AIIMS)
College Block
Basni Phase-II, Jodhpur – 342005
Rajasthan, India
NA
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9898187911 |
| Fax |
|
| Email |
suryapriyam5619@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Remiya Mohan |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, Jodhpur |
| Address |
Department of Pediatrics
All India Institute of Medical Sciences (AIIMS)
College Block
room no.225
Basni Phase-II, Jodhpur – 342005
Rajasthan, India
NA
Jodhpur
RAJASTHAN
342005,
India |
| Phone |
8003991316 |
| Fax |
|
| Email |
remiya1986@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suresh K Sharma |
| Designation |
Principal cum Professor |
| Affiliation |
AIIMS, Jodhpur |
| Address |
Department of Pediatrics
All India Institute of Medical Sciences (AIIMS)
College Block
room no 112
Basni Phase-II, Jodhpur – 342005
Rajasthan, India
All India Institute of Medical Sciences (AIIMS) Jodhpur
Basni Industrial Area Phase-II,
Jodhpur – 342005, Rajasthan, India
Jodhpur
RAJASTHAN
342005,
India |
| Phone |
8475000293 |
| Fax |
|
| Email |
sharmask@aiimsjodhpur.edu.in |
|
|
Source of Monetary or Material Support
|
|
All India Institute of Medical Sciences (AIIMS)
College Block
Basni Phase-II, Jodhpur – 342005
Rajasthan, India |
|
|
Primary Sponsor
|
| Name |
Ms Suryapriya Nellaikumar Pandaram |
| Address |
All India Institute of Medical Sciences (AIIMS) Jodhpur
Basni Industrial Area Phase-II,
Jodhpur – 342005, Rajasthan, India |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Suryapriya |
AIIMS, Jodhpur |
All India Institute of Medical Sciences (AIIMS) Jodhpur
Basni Industrial Area Phase-II,
Jodhpur – 342005, Rajasthan, India
PEDIATRIC DEPT ROOM NO 225
Jodhpur
RAJASTHAN |
09898187911
suryapriyam5619@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instutional Ethics committee, AIIMS, JODHPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: X||New Technology, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
routine immunization |
routine immunization process without using pain reduction device FOR 3 WEEKS |
| Intervention |
shot blocker |
Application of Shot Blocker device just before and during intramuscular immunization in infants to reduce pain perception. FOR 3 WEEKS |
|
|
Inclusion Criteria
|
| Age From |
1.50 Month(s) |
| Age To |
3.50 Month(s) |
| Gender |
Both |
| Details |
1. Infants undergoing immunization aged between 6 weeks to 1 year.
2. Infants undergoing pentavalent Intramuscular and Pneumococcal Conjugate Vaccine Intramuscular injection.
3. Available during data collection.
4. The guardian of the infants who provide the consent.
5. The guardian of infants who can understand Hindi or English.
|
|
| ExclusionCriteria |
| Details |
1. Infants diagnosed with chronic diseases. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| decreased pain during immunization |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="163"
Sample Size from India="163"
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)
|
20/10/2025 |
| 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="1"
Months="0"
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 - NO
|
|
Brief Summary
|
Aim · To assess the effectiveness of Shot Blocker on pain during immunization among infants Objectives · To assess and compare pain score of infants receiving immunization in experimental group and control group · To find association of pain score of infants receiving immunization with their selected sociodemographic and clinical variables
H0: There is no significant difference in pain score between infants receiving immunization with and without Shot Blocker H1: There is significant difference in pain score between infants receiving immunization with and without Shot Blocker
|