Condition category
Neonatal Diseases
Date applied
17/08/2019
Date assigned
21/08/2019
Last edited
20/08/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

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

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

http://www.unissula.ac.id

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

Publication citations

Additional files

Editorial Notes

20/08/2019: Trial’s existence confirmed by Ethics Committee of the Faculty of Nursing, Unissula