| CTRI Number |
CTRI/2021/12/038396 [Registered on: 02/12/2021] Trial Registered Prospectively |
| Last Modified On: |
29/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Randomized Control Trial, Post Test only Control Design] |
| Study Design |
Other |
|
Public Title of Study
|
A study to asses effectiveness of skin tap technique to reduce intra muscular vaccination pain |
|
Scientific Title of Study
|
Effect of Helfer Skin Tap Technique on Pain reduction among infants undergoing intramuscular vaccination attending immunization clinic in a selected hospital, Berhampur, Ganjam, Odisha. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
TAPASWINI DASH |
| Designation |
P.G Student (M.Sc Nursing, Child Health) |
| Affiliation |
Govt. College of Nursing, MKCG MCH, Berhampur |
| Address |
Govt. College of Nursing, MKCG Medical College Campus, NH-59, Berhamapur, Odisha
Ganjam
ORISSA
760004
India |
| Phone |
7205533064 |
| Fax |
|
| Email |
tapaswinidash95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Swarnaprava Behera |
| Designation |
Clinical Instructor (M.Sc Nursing, Child Health) |
| Affiliation |
Govt. College of Nursing, MKCG MCH, Berhampur |
| Address |
Govt. College of Nursing, MKCG Medical College Campus, NH-59, Berhamapur, Odisha
Ganjam
ORISSA
760004
India |
| Phone |
9439198560 |
| Fax |
|
| Email |
swarnaprava27@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
TAPASWINI DASH |
| Designation |
P.G Student (M.Sc Nursing, Child Health) |
| Affiliation |
Govt. College of Nursing, MKCG MCH, Berhampur |
| Address |
Govt. College of Nursing, MKCG Medical College Campus, NH-59, Berhamapur, Odisha
Ganjam
ORISSA
760004
India |
| Phone |
7205533064 |
| Fax |
|
| Email |
tapaswinidash95@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt. College of Nursing, MKCG Medical College, Berhamapur, Odisha |
|
|
Primary Sponsor
|
| Name |
TAPASWINI DASH |
| Address |
Govt. College of Nursing, MKCG Medical College Campus, NH-59, Berhamapur, Odisha, Pin-760004 |
| 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 |
| TAPASWINI DASH |
MKCG Medical College and Hospital |
MKCG Medical College Campus NH 59 Berhamapur Odisha Pin 760004
Ganjam
ORISSA |
7205533064
tapaswinidash95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee M.K.C.G Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
infant (6wk to 6 month) for intramuscular vaccination |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Helfer Skin Tap Technique |
After preparing the skin with spirit swab make a large V with the index finger and thumb of the non-dominant hand and tap the muscle which is intended to use the palmer aspect of the fingers 16 times before insertion of the needle 3 counts of tapping near vaccination site during administration of vaccine Apply continuous tapping until needle is remove Post assessment of pain level by using FLACC pain scale for during vaccination after 1st minute 5th minutes 10th minute |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
1.50 Month(s) |
| Age To |
6.00 Month(s) |
| Gender |
Both |
| Details |
1 Infants available for sampling during data collection period undergoing intramuscular vaccination
2 Those parents will give consent for the study
|
|
| ExclusionCriteria |
| Details |
Those parents will not give consent for the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Alleviation of pain through effective skin tap technique |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction of pain through effective skin tap technique |
1 month |
|
|
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)
|
10/12/2021 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is randomized controlled trail (RCT), post-test only control design (parallel group) which consists of the principles of randomization and control to asses effect of helfer skin tap technique infants undergoing intramuscular vaccination in a selected medical college Odisha, India. The primary output measures will be alleviation of pain 6wk – 1 years infants during intramuscular vaccination through effective skin tap technique. |