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
Mrs Nopi Khasanah
Jl Raya Kaligawe Km.4
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
Facilitated tucking is more effective done by mothers then by health worker
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
Interventional randomised controlled trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Infant distress during immunization procedure
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.
Primary outcome measure
Pain level in infants measured using FLACC (face, legs, activity, cry, consolability) scale at the time of immunisation
Secondary outcome measures
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
Infants aged 2-12 months that underwent DPT immunization in Bangetayu Health Center Semarang
Target number of participants
Participant exclusion criteria
Infants with chronic condition
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Bangetayu Health Center
JL. Bangetayu Genuk
Universitas Islam Sultan Agung
Funding Body Type
Funding Body Subtype
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: firstname.lastname@example.org, 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
Participant level data
Available on request
Basic results (scientific)