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 designInterventional randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typePrevention
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleFacilitated 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 objectivesFacilitated 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) studiedInfant distress during immunization procedure
InterventionParticipants 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 typeProcedure/Surgery
Primary outcome measurePain level in infants measured using FLACC (face, legs, activity, cry, consolability) scale at the time of immunisation
Secondary outcome measuresInfants age
Overall study start date13/07/2018
Completion date19/09/2018

Eligibility

Participant type(s)Patient
Age groupNeonate
SexBoth
Target number of participants48
Total final enrolment48
Key inclusion criteriaInfants aged 2-12 months that underwent DPT immunization in Bangetayu Health Center Semarang
Key exclusion criteriaInfants with chronic condition
Date of first enrolment08/08/2018
Date of final enrolment29/08/2018

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 logo "ROR" https://ror.org/015hejj83

Funders

Funder type

University/education

Universitas Islam Sultan Agung

No information available

Results and Publications

Intention to publish date18/09/2019
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned 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