| CTRI Number |
CTRI/2025/06/089190 [Registered on: 19/06/2025] Trial Registered Prospectively |
| Last Modified On: |
17/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of tapping on the skin on pain of babies |
|
Scientific Title of Study
|
Effectiveness of Helfer Skin Tap Technique on Pain and Physiological Parameters among Infants during Intramuscular Vaccination in a Selected Tertiary Care Hospital, Mangaluru. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Palakonda Pragathi |
| Designation |
Post Graduate Student |
| Affiliation |
Father Muller College of Nursing |
| Address |
Father Muller College of Nursing
Child Health Nursing Department
3rd floor
Kakanandy
Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9618431674 |
| Fax |
|
| Email |
pragathip664@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Wilma Shalini Norohna |
| Designation |
HOD, Professor |
| Affiliation |
Father Muller College of Nursing |
| Address |
Father Muller College of Nursing
Kakanandy
Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9481765777 |
| Fax |
|
| Email |
wilmashalini04@fathermuller.in |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Wilma Shalini Norohna |
| Designation |
HOD, Professor |
| Affiliation |
Father Muller College of Nursing |
| Address |
Father Muller College of Nursing
Kakanandy
Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9481765777 |
| Fax |
|
| Email |
wilmashalini04@fathermuller.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Palakonda Pragathi |
| Address |
Father Muller College of Nursing
Child Health Nursing Department
3rd floor
Kakanandy Mangalore 575002
|
| 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 |
| Mrs Wilma Shalini Noronha |
Father Muller Medical College and Hospital |
Father Muller Charitable Institutions
Pediatric Department, Immunization Clinic, 1st floor
Kankanady, Mangalore
Dakshina Kannada
KARNATAKA |
9481765777
wilmashalini04@fathermuller.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Infants Receiving Intramuscular Vaccination |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Helfer Skin Tap Technique |
The Helfer Skin Tap Technique for administering intramuscular vaccinations to infants aged six to twelve months. The procedure involves identifying the injection site and tapping the site sixteen times with the palm of the dominant hand for approximately five seconds to help relax the muscle. The thumb and fingers are then positioned to form a "V" shape, and the skin is tapped three times. Following this, the needle is inserted into the vastus lateralis muscle of the thigh. After the needle is withdrawn, the investigator taps the skin three additional times. The investigator will assess the pain and physiological parameters immediately after vaccination by using pain scale and observational checklist. The total duration of the intervention will be 3 to 5 seconds. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
12.00 Month(s) |
| Gender |
Both |
| Details |
1. Healthy infants from six months to twelve
months of age.
2. Infants of both genders.
3. Infants receiving intramuscular vaccine.
|
|
| ExclusionCriteria |
| Details |
1. From birth to 28 days
2. Preterm and low birth weight neonates
3. With congenital abnormalities
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effectiveness of Helfer Skin Tap Technique on Pain and Physiological Parameters among Infants during Intramuscular Vaccination |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reducing the pain during any painful procedure |
6 months |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
30/06/2025 |
| 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
|
This study teaches about the Helfer Skin Tap Technique which is helpful in the reducing the pain during the painful procedure in children during the Intramuscular Vaccination. |