| CTRI Number |
CTRI/2012/07/002780 [Registered on: 10/07/2012] Trial Registered Retrospectively |
| Last Modified On: |
09/07/2012 |
| 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
|
A clinical trial comparing the vaccination related pain of two different vaccination techniques in children under one and half years. |
|
Scientific Title of Study
|
“Vaccination related pain: randomized controlled trial, comparison of pain of two injection techniques†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Girish G N |
| Designation |
Junior Resident in Pediatrics |
| Affiliation |
JSS Medical College, JSS University, Mysore |
| Address |
No.1, 8th main, T Block – 1
Bogadi 2nd stage (south), Mysore
Karnataka
Mysore KARNATAKA 570026 India |
| Phone |
9886974232 |
| Fax |
|
| Email |
girish.gn@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr M D Ravi |
| Designation |
Professor in Pediatrics |
| Affiliation |
JSS Medical College, JSS University, Mysore |
| Address |
Department of Pediatrics,
JSS Medical College Hospital,
Ramanuja Road,
Mysore,
Karnataka
Mysore KARNATAKA 570004 India |
| Phone |
9880629506 |
| Fax |
|
| Email |
ravimdped@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Girish G N |
| Designation |
Junior Resident in Pediatrics |
| Affiliation |
JSS Medical College, JSS University, Mysore |
| Address |
No.1, 8th main, T Block – 1
Bogadi 2nd stage (south), Mysore
Karnataka
Mysore KARNATAKA 570026 India |
| Phone |
9886974232 |
| Fax |
|
| Email |
girish.gn@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatrics,
JSS Medical College,
Ramanuja Road, Mysore, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
JSS Medical college |
| Address |
Department of Pediatrics,
JSS Medical College hospital,
Ramanuja Road, Mysore - 570004 Karnataka, India |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr M D Ravi |
Vice Principal and Professor of Pediatrics,
JSS medical College hospital,Ramanuja road, Mysore, Karnataka |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Girish G N |
JSS medical college Hospital |
Department of Pediatrics,
JSS Hospital,
Ramanuja road, Mysore Mysore KARNATAKA |
9886974232
girish.gn@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSS Medical College Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pain during vaccination |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Changing the vaccination technique |
Standard group received immunisation using standard slow technique with aspiration and Pragmatic group received immunisation using “pragmatic†technique where needle advanced fast, injected without aspiration and needle was withdrawn fast. whole procedure was completed in 1-2 sec. |
| Comparator Agent |
Standard vaccination technique |
Standard vaccination technique of slow advancement of needle followed by aspiration, injection and then slow removal of needle. whole process was completed in 5- 10 sec |
|
|
Inclusion Criteria
|
| Age From |
42.00 Day(s) |
| Age To |
18.00 Month(s) |
| Gender |
Both |
| Details |
All healthy infants of age group 6 weeks to one and half years receiving routine intramuscular DTwP vaccination. |
|
| ExclusionCriteria |
| Details |
Any criteria which precludes immunization. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome measured was immediate infant pain response assessed using the Modified Behavior Pain Score which was scored from the videotape analysis. |
post immunization pain score within 15 sec of the immunization |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome measures included infant crying time assessed from videotapes. |
start of cry to till it ends |
|
|
Target Sample Size
|
Total Sample Size="200" Sample Size from India="200"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/12/2008 |
| 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="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Methodology: In this Randomised Controlled Trial, source of data were 200 healthy infants of age group 6 weeks to one and half years, receiving routine intramuscular vaccination. They were divided randomly using computer generated random numbers into Standard group receiving immunisation using standard slow technique with aspiration and Pragmatic group receiving immunisation using “pragmatic†technique without aspiration. The entire vaccination procedure was videotaped. Videos were scored for pain using Modified Behavior Pain Score by 2 clinical psychologists and the mean score was considered for analysis. Pain was scored within 15 s of the immunization were measured and described the child’s maximal pain response to the injection. Cry time was measured from the start of cry till it ends by a different person. Entire data was entered in a preformed proforma. The Z test for two sample population means was used for statistical analysis. Results: Standard technique required a longer duration (5-10 sec) when compared to pragmatic technique (1-2 sec). Mean Post vaccination MBPS in standard Group was 8.4 and in Pragmatic Group was 7.8 which was statistically significant. Crying duration in pragmatic group was less (32.1 sec) than standard group (37.37sec). Conclusion: The “standard†slow technique was significantly more painful and took longer to administer than the “pragmatic†rapid technique. |