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

University of Yalova

Status: Enrolling

Conditions: Procedural Pain

Treatments: Device: Local Vibration Group; Behavioral: Audio Book Group

Study type: Interventional

Funder types: Other

Identifiers

NCT06354608

duygudemirr

Details and patient eligibility

About

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.

Full 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).

Enrollment: 120 estimated patients

Sex: All

Ages: 4 to 6 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• The child and family agree to participate in the research,
• The child is between the ages of 4-6,
• The child does not have a chronic and mental health problem,
• Absence of visual, auditory problems or mental retardation at a level that can fill the scales,
• No history of sedative, analgesic or narcotic substance use within 24 hours before admission,
• Absence of a disease causing chronic pain,
• Not having a febrile illness at the time of application,
• Being treated in the pediatric emergency unıt at the time of the study,
• Intramuscular injection in the vastus lateralis region,
• Ondansetron will be injected intramuscularly in the vastus lateralis area, as directed by the doctor.
• Performing the operation at once.

Exclusion criteria

• The child and family's refusal to participate in the research,
• Having a visual and auditory problem
• The child is less than 4 years old or older than 6 years old
• The child has a chronic and mental health problem
• The child experiences pain,
• To have taken analgesic medication in the last 6 hours.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

Audio Book Group

Experimental group

Description:

Audiobooks are stories with illustrated stories, and these stories are voiced. Audiobooks are visual and auditory distractions. The researcher will introduce this audio book to both children and parents before the procedure. The child will be allowed to examine the book. Before starting the IM injection procedure, the researcher will show the pages of the book and start the story. The story will be supported by showing the pictures in the book to attract the child's attention. After the child concentrates on the story, the child's leg area where the vastus lateralis muscle is located will be hygienized before the IM injection. During the entire IM injection procedure, the audiobook will continue until the end of the procedure.

Treatment:

Behavioral: Audio Book Group

Local Vibration Group

Experimental group

Description:

A local vibration device, an electric vibration device, will be used. During the application, the device must be in full contact with the skin. Local vibration application reduces perceived pain by stimulating nerve fibres according to Melzack and Wall's Gate Control Theory. In the local vibration group, local vibration is applied to the leg area of the child where the vastus lateralis muscle is located for 30 seconds before the IM injection is applied with the vibrating Dolphin massage device. Then, the leg area will be hygienized, and the device will be placed 3-5 cm above the injection area during the procedure, and IM injection will be performed. The device must be in full contact with the skin during the application.

Treatment:

Device: Local Vibration Group

Control Group

No Intervention group

Description:

Children in the control group will be received standard care. Control group children will not receive any distraction techniques.