MedTrace Logo

The Effect of Audio Book and Local Vibration on Pain and Fear in Intramuscular Injection in Children

NCT06354608 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-06-25

No results posted yet for this study

Summary

The study is conducted based on a randomized controlled experimental design to determine the effect of an audio book and local vibration on intramuscular injection in pediatric emergency unit patients aged 4-6 years on pain and fear.

Conditions

  • Procedural Pain

Interventions

BEHAVIORAL

Audio Book Group

Audiobook will be applied during the entire IM injection procedure and until the end of the procedure. After the procedure is over, the children will be taken to the waiting area. After being allowed to rest for 1-2 minutes, the child will be asked to rate their level of pain and fear during the procedure. A parent who is with the child and observes the child's behavior, and the same nurse who is independent from the study, will independently rate the child's pain and fear level during the procedure.

DEVICE

Local Vibration Group

In the local vibration group, IM injection will be performed with a vibrating massage device. After the procedure is finished, the children will be taken to the waiting section. After being allowed to rest for 1-2 minutes, the child will be asked to rate their level of pain and fear during the procedure. A parent who is with the child and observes the child's behavior and the same nurse who is independent from the study will independently rate the pain and fear level of the child during the procedure.

Sponsors & Collaborators

  • University of Yalova

    lead OTHER

Principal Investigators

  • Duygu Demir, Assis. Prof. · Director

  • Derya Kılıç, Assis. Prof. · Researcher

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-25
Primary Completion
2024-06-21
Completion
2024-07-01

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06354608 on ClinicalTrials.gov