The efficacy of mother's involvement to comfort infants during immunization

ISRCTN	ISRCTN43763425
DOI	https://doi.org/10.1186/ISRCTN43763425
Secondary identifying numbers	207/A.1/FIK-SA/VII/2018

Submission date: 17/08/2019
Registration date: 21/08/2019
Last edited: 11/03/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Neonatal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Mrs Nopi Khasanah
Public

Jl Raya Kaligawe Km.4
Semarang
50112
Indonesia

Phone	+6285640256378
Email	nopi.khasanah@unissula.ac.id

Study information

Study design	Interventional randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Prevention
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
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
Study objectives	Facilitated tucking is more effective done by mothers then by health worker
Ethics approval(s)	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
Health condition(s) or problem(s) studied	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
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 study start date	13/07/2018
Completion date	19/09/2018

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	Both
Target number of participants	48
Total final enrolment	48
Key inclusion criteria	Infants aged 2-12 months that underwent DPT immunization in Bangetayu Health Center Semarang
Key exclusion criteria	Infants with chronic condition
Date of first enrolment	08/08/2018
Date of final enrolment	29/08/2018

Locations

Countries of recruitment

Indonesia

Study participating centre

Bangetayu Health Center

JL. Bangetayu
Genuk
Semarang
50115
Indonesia

Sponsor information

Sultan Agung Islamic University
University/education

Jl Raya Kaligawe km.4
Semarang
50112
Indonesia

Phone	(024) 6583584
Email	info@unissula.ac.id
Website	http://www.unissula.ac.id
"ROR"	https://ror.org/015hejj83

Funders

Funder type

University/education

Universitas Islam Sultan Agung

No information available

Results and Publications

Intention to publish date	18/09/2019
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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)
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2019	11/03/2020	Yes	No

Editorial Notes

11/03/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
20/08/2019: Trial’s existence confirmed by Ethics Committee of the Faculty of Nursing, Unissula