Plain English Summary
Background and study aims
A diphtheria pertussis tetanus (DPT) immunization often causes trauma in infants because it's done by intramuscular injection.
The aim of this study is to determine the effect of facilitated tucking by mothers combined with sitting up position on the level of pain when infants received DPT immunization
Who can participate?
Infants aged 2-12 months that underwent DPT immunization in Bangetayu Health Center Semaran and their mothers
What does the study involve?
Participants will be randomly allocated to one of three groups: (A) facilitated tucking (making flexion on the infant arm) by mothers (B) facilitated tucking by a health worker (C) sitting up position
What are the possible benefits and risks of participating?
Benefit: alleviate the pain level in infants, make the infants more comfort
Risk: there is no risk in this study
Where is the study run from?
Bangetayu Health Center, Indonesia
When is the study starting and how long is it expected to run for?
August 2018 for one month
Who is funding the study?
Sultan Agung Islamic University
Who is the main contact?
Nopi Nur Khasanah
nopi.khasanah@unissula.ac.id
Trial website
Contact information
Type
Public
Primary contact
Mrs Nopi Khasanah
ORCID ID
Contact details
Jl Raya Kaligawe Km.4
Semarang
50112
Indonesia
+6285640256378
nopi.khasanah@unissula.ac.id
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
207/A.1/FIK-SA/VII/2018
Study information
Scientific title
Facilitated tucking by mothers compared to facilitated tucking by health worker, facilitated tucking by mothers compared to sitting up position by mothers, facilitated tucking by health worker compared to sitting up position by mothers in the comfort of infants during the intramuscular immunization procedure
Acronym
Study hypothesis
Facilitated tucking is more effective done by mothers then by health worker
Ethics approval
Approved 13/07/2018 Ethics Committee of the Faculty of Nursing, Unissula (Komite Etik Fakultas Ilmu Keperawatan Unissula, Jl. Raya Kaligawe Km. 4 Semarang 50112, Po Box 1054, Indonesia; +62 24 6583584), ref: 207/A.1/FIK-SA/VII/2018
Study design
Interventional randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Infant distress during immunization procedure
Intervention
Participants are divided into three groups randomly by picking up one of three folded paper (A/B/C, A means that the participants included in group 1; B means that participants included in group 2; C means participants included in the control group).
After random allocation, all participants fill out the questionnaire and for the mothers and the health worker wearing the same clothes as the mother.
Group 1: infants sitting up on the mother's lap and mothers make infant's arm flex then the midwife will give an intramuscular immunization
Group 2: infants sitting up on the health worker lap and health worker make infant's arm flex then the midwife will give an intramuscular immunization
Control group: infants sitting up on the mother's lap then the midwife will give an intramuscular immunization.
Video recorded on each participant roughly 5 minutes and send to a pediatric nurse specialist to observe and rate pain according to the FLACC scale.
Data were analyzed by Kruskal-Wallis test and post hoc Mann-Whitney test.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Pain level in infants measured using FLACC (face, legs, activity, cry, consolability) scale at the time of immunisation
Secondary outcome measures
Infants age
Overall trial start date
13/07/2018
Overall trial end date
19/09/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Infants aged 2-12 months that underwent DPT immunization in Bangetayu Health Center Semarang
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
48
Total final enrolment
48
Participant exclusion criteria
Infants with chronic condition
Recruitment start date
08/08/2018
Recruitment end date
29/08/2018
Locations
Countries of recruitment
Indonesia
Trial participating centre
Bangetayu Health Center
JL. Bangetayu
Genuk
Semarang
50115
Indonesia
Sponsor information
Organisation
Sultan Agung Islamic University
Sponsor details
Jl Raya Kaligawe km.4
Semarang
50112
Indonesia
(024) 6583584
info@unissula.ac.id
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Universitas Islam Sultan Agung
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
The datasets generated during and/or analysed during the current study are/will be available upon request from https://drive.google.com/drive/folders/1QhTTRvVMhkhVXdCzofiPPuWrpyMCc5uE?usp=sharing (Name: Nopi Nur Khasanah, Email: nopi.khasanah@unissula.ac.id, type of data: video recorded, The data will become available on August 2019 for 2 years, data will be shared by google drive, types of analyses by observational, and the mechanism by FLACC scale, consent from participants was obtained, data was anonymous, no legal restrictions)
Intention to publish date
18/09/2019
Participant level data
Available on request
Basic results (scientific)
Publication list
2019 results in http://doi.org/10.36295/ASRO.2019.221147 (added 11/03/2020)