| CTRI Number |
CTRI/2021/11/037737 [Registered on: 01/11/2021] Trial Registered Prospectively |
| Last Modified On: |
26/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Breastfeeding versus manual pressure] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of breastfeeding versus manual pressure on pain during intramuscular injection among infants in immunization clinic of a selected tertiary care hospital Bangalore. |
|
Scientific Title of Study
|
A comparative study to assess the effectiveness of breastfeeding versus manual pressure on pain during intramuscular injection among infants at selected immunization clinics. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mrs Jaya Patel |
| Designation |
M. Sc. Nursing (Department of Child Health Nursing) |
| Affiliation |
Narayana Hrudayalaya College of Nursing |
| Address |
Narayana Hrudayalaya College of Nursing, 258/A, Narayana Health City, Bommasandra Industrial Area, Anekal Taluk,
Bangalore
India
Bangalore
KARNATAKA
560099
India |
| Phone |
8770414687 |
| Fax |
|
| Email |
jayabrijeshp56@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Bincymol Mathew M |
| Designation |
Assistant Professor |
| Affiliation |
Narayana Hrudayalaya College of Nursing |
| Address |
Narayana Hrudayalaya College of Nursing, 258/A, Narayana Health City, Bommasandra Industrial Area, Anekal Taluk,
Bangalore
India
Bangalore
KARNATAKA
560099
India |
| Phone |
9019665740 |
| Fax |
|
| Email |
bles534@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Jaya Patel |
| Designation |
M. Sc. Nursing (Department of Child Health Nursing) |
| Affiliation |
Narayana Hrudayalaya College of Nursing |
| Address |
Narayana Hrudayalaya College of Nursing, 258/A, Narayana Health City, Bommasandra Industrial Area, Anekal Taluk,
Bangalore
India
Bangalore
KARNATAKA
560099
India |
| Phone |
8770414687 |
| Fax |
|
| Email |
jayabrijeshp56@gmail.com |
|
|
Source of Monetary or Material Support
|
| Narayana Hrudayalaya College of Nursing, 258/A, Narayana Health City, Bommasandra Industrial Area, Anekal Taluk, Bangalore - 560099, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Mrs Jaya Patel |
| Address |
Narayana Hrudayalaya College of Nursing, 258/A, Narayana Health City, Bommasandra Industrial Area, Anekal Taluk, Bangalore - 560099, Karnataka, India |
| 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 |
| A Lilly Catherene |
Mazumdar Shaw Medical Center |
Room no. C-13, Immunization Clinic, 1st Floor, Mazumdar Shaw Medical Center, 258/A, Narayana Health City, Bommasandra Industrial Area, Anekal Taluk, Bangalore - 560099
Bangalore
KARNATAKA |
8886500697
lillycatherena@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Narayana Health Academic Ethics Committee, Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Intra muscular immunization |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Breastfeeding |
In the breast feeding group mother
will give breast feeding to the
baby 20 minutes prior to the
immunization procedure. |
| Intervention |
Manual Pressure |
In the manual pressure group:
(1)Manual pressure application for 10 second in lumber vertebra (L1-L4) in infants hands will be given by the researcher just 30 second prior to the intramuscular injection.
(2)Intramuscular injection will be given by placing baby on the examination table.
(3)The staff nurse who will be posted in immunization clinic of OPD will give the injection.
(4)The video will be recorded to know the infants reaction towards the pain by the researcher.
(5)The pain evaluation will be done by the research assistant who is trained in the FLACC pain scale (Single Blind Study). |
| Comparator Agent |
The Pain |
To reduce the pain during the time of intra muscular immunization injection among infants. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Month(s) |
| Age To |
12.00 Month(s) |
| Gender |
Both |
| Details |
Infants (2- 12 months) who will be healthy and receive intramuscular injection.
Mother those who breastfeed the infant for breastfeeding group. |
|
| ExclusionCriteria |
| Details |
Infants with neurological and developmental delay.
Infants those who have taken analgesic medicine before the immunisation procedure.
Parents who will not be ready for the videography during intramuscular injection among infants |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Demographic variables such as age, gestational age, gender, weight, number of previous intra muscular injection exposure, name of the vaccine, dose of vaccine, health condition of infants. |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Application of breast feeding or manual pressure during intramuscular immunization among infant might reduce pain. |
8 weeks |
|
|
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)
|
03/11/2021 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nill |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The purpose of this study to know which one is more effective in reducing pain, either breastfeeding or manual pressure during the intramuscular injection among infants at immunisation clinic tertiary care hospital Bangalore. |