| CTRI Number |
CTRI/2024/12/078538 [Registered on: 24/12/2024] Trial Registered Prospectively |
| Last Modified On: |
23/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision of pain in intramuscular vaccination techniques with and without aspiration |
|
Scientific Title of Study
|
Comparision of pain in intramuscular vaccination techniques with and without aspiration ;A randomized control 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 |
Thejaswini |
| Designation |
Post graduate junior resident |
| Affiliation |
Sri manakula vinayagar medical college and hospital |
| Address |
room number 99 Paediatric opd Department of paediatrics Srimanakula vinayagar medical college and hospitalkalitheerthalkuppam, Madagadipet
Room number 99, Paediatrics opd, Department of paediatrics, Srimanakula vinayagar medical college and hospital,kalitheerthalkuppam, Madagadipet
Pondicherry
PONDICHERRY
605107
India |
| Phone |
7093993229 |
| Fax |
|
| Email |
thejaswinip97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrBharath Kumar |
| Designation |
PROFESSOR &HOD OF PEDIATRICS: |
| Affiliation |
Sri manakula vinayagar medical college and hospital |
| Address |
Room number 99, Paediatrics opd, Department of paediatrics, Srimanakula vinayagar medical college and hospital,kalitheerthalkuppam, Madagadipet
Room number 99, Paediatrics opd, Department of paediatrics, Srimanakula vinayagar medical college and hospital,kalitheerthalkuppam, Madagadipet
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9003468873 |
| Fax |
|
| Email |
Scooby_25575@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DrBharath Kumar |
| Designation |
PROFESSOR &HOD OF PEDIATRICS: |
| Affiliation |
Sri manakula vinayagar medical college and hospital |
| Address |
Room number 99, Paediatrics opd, Department of paediatrics, Srimanakula vinayagar medical college and hospital,kalitheerthalkuppam, Madagadipet
Room number 99, Paediatrics opd, Department of paediatrics, Srimanakula vinayagar medical college and hospital,kalitheerthalkuppam, Madagadipet
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9003468873 |
| Fax |
|
| Email |
Scooby_25575@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Sri manakula vinayagar medical College and hospital ,kalitheerthakuppam Madagadipet puducherry ,INDIA,605107 |
|
|
Primary Sponsor
|
| Name |
Thejaswini patam |
| Address |
Room number 99, Paediatrics opd, Department of paediatrics, Srimanakula vinayagar medical college and hospital,kalitherrthalkuppam, Madagadipet, PuducherryPondicherryPONDICHERRY |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| DrThejaswini patam |
Sri manakula vinayagar medical College and |
Room number 99, Paediatrics opd, Department of paediatrics,Sri manakula vinayagar medical College and hospital kalitheerthalkuppam, Madagadipet, Puducherry,605 107IndiaKalitheerthakuppam, Madagadipet
Pondicherry
PONDICHERRY |
7093993229
thejaswinip97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMVMCH -ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Infants under going intramuscular vaccination |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aspiration |
Before giving intramuscular vaccination,syringe is aspirated for 1 second and then the procedure is continued.Total time duration compared is 2 seconds more than usual procedure |
| Comparator Agent |
Group of infants receiving intramuscular vaccination without aspiration |
To compare the pain in between two different groups,one with intramuscular vaccination with aspiration and other without aspiration |
|
|
Inclusion Criteria
|
| Age From |
42.00 Day(s) |
| Age To |
1.00 Year(s) |
| Gender |
Both |
| Details |
Vacination is the most painful procedure faced during childhood causing fear,anxiety and non-compliance of vaccinationwhich may even lead to fear and avoidance of treatment in adulthood.The study will be carried out among the infants of 6weeks to 1 year undergoing vaccination in from Sri ManakulaVinayagar Medical College and Hospital, Madagadipet, Pondicherry and PHC, Pondicherry |
|
| ExclusionCriteria |
| Details |
Known allergy for vaccination, parents not willing , infants with impaired neurological development, administration of sedatives |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare acute pain response in infants with and without aspiration during intramuscular vaccination.
|
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Infant Recovery Time
Time taken for the infant to return to a calm or baseline state after the procedure. |
10 minutes |
|
|
Target Sample Size
|
Total Sample Size="214"
Sample Size from India="214"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
04/01/2025 |
| 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="2"
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
|
Vacination is the most painful procedure faced during childhood causing fear,anxiety and non-compliance of vaccinationwhich may even lead to fear and avoidance of treatment in adulthood.The study will be carried out among the infants of 6weeks to 1 year undergoing vaccination in from Sri ManakulaVinayagar Medical College and Hospital, Madagadipet, Pondicherry and PHC Pondicherry |