The efficacy of mother's involvement to comfort infants during immunization
| ISRCTN | ISRCTN43763425 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43763425 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 207/A.1/FIK-SA/VII/2018 |
| Sponsor | Sultan Agung Islamic University |
| Funder | Universitas Islam Sultan Agung |
- 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
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
Public
Jl Raya Kaligawe Km.4
Semarang
50112
Indonesia
| Phone | +6285640256378 |
|---|---|
| nopi.khasanah@unissula.ac.id |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | 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(s) |
Pain level in infants measured using FLACC (face, legs, activity, cry, consolability) scale at the time of immunisation |
| Key secondary outcome measure(s) |
Infants age |
| Completion date | 19/09/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | All |
| Target sample size at registration | 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
Genuk
Semarang
50115
Indonesia
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| 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 |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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
