NCT06354608

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

The Effect of Audio Book and Local Vibration on Pain and Fear in Intramuscular Injection in Children: A Randomised Controlled Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: University of Yalova · Academic / Other
• Sex: All
• Age: 4 Years – 6 Years
• Healthy volunteers: Accepted

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.

Detailed description

IM injection is one of the medical procedures that causes pain and fear in children. It has been reported that the effect of children's previous pain and fearful experiences continues into adulthood, and this may lead to the avoidance of subsequent medical procedures as a reaction to increased pain and fear. For all these reasons, pediatric nurses and other healthcare professionals should aim for successful pain control before and during painful procedures in children to prevent future adverse effects of painful medical procedures. Reducing the emotional impact of painful procedures in clinical practice through better pain control is very important for children. Therefore, all healthcare professionals, especially nurses, as the first person to welcome children into the hospital and the person who spends the most time with the child, have important responsibilities in eliminating children's fear of medical procedures. It is very important for pediatric nurses to use nonpharmacological techniques to reduce pain in the IM injection procedure. It is known that non-pharmacological pain control methods help the child cope with pain, reduce pain, and alleviate distress from invasive procedures. The most commonly used of these approaches is the distraction technique, also known as the distraction technique, which is constructed with cognitive and behavioral processes. These include relaxation techniques, deep breathing, listening to music, singing and talking, watching cartoons, games, vibration and cold applications, and distraction cards. As understood from the studies, nonpharmacological approaches help the child cope with the pain experienced in invasive interventions and provide less pain. It is critical that all pediatric nurses and other healthcare workers who work with children learn about and practice pain-reduction techniques. When the literature was reviewed, it was discovered that there were no studies comparing audiobook and local vibration application to reduce pain and fear perceived during IM injections administered to pediatric patients, whereas there were a limited number of studies evaluating the methods independently. It is thought that there is a need for planning randomized controlled experimental nursing studies in this field. This study is planned to determine the effect of the use of audio book and local vibration on the pain and fear experienced by children during intramuscular injection in children aged 4-6 years. While the population of the study consisted of pediatric patients aged 4-6 years in the pediatric emergency unit between October 2023 and April 2024, the sample consisted of 120 children who met the sample selection criteria. The research consists of 3 groups. These groups will audio book group (n=40), local vibration group (n=40), and control group (n=40). In order for the groups to be distributed homogeneously, the order produced by a computer program (http://www.randomization.com, Balanced permutation) was used. Patients who meet the inclusion criteria and agree to participate in the study assigned to the experimental and control groups according the randomization list. The control variable of the study is demographic characteristics of the children. The dependent variables of the study are pain and fear score. The data are collected using Introductory Information Form, Wong-Baker FACES Pain Scale (W-BPS), Children's Fear Scale (CFS).

Conditions

• Procedural Pain

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-10-25
• Primary completion: 2024-06-21
• Completion: 2024-07-01
• First posted: 2024-04-09
• Last updated: 2024-06-25

Locations

1 site across 1 country: Turkey (Türkiye)