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

April 8, 2024 updated by: Duygu Demir, University of Yalova

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Audio Book Group
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.
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.
Experimental: Local Vibration Group
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.
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.
No Intervention: Control Group
Children in the control group will be received standard care. Control group children will not receive any distraction techniques.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the pain score values of the groups Pain assesed by Wong-Baker FACES
Time Frame: Pain levels of the children will be evaluated 1 minute after the procedure.
The Wong-Baker Faces Pain Scale revised (W-BFS) is used to determine the level of pain during the procedure. The W-BFS is a scale that is most commonly used in identifying pain in children of the ages 3 to 18. It is reported that the scale is reliable when used with children older than the age of 3 who can verbally express the degree of pain they feel. The scale is made up of faces and numbers. Pain is assessed on a scale of "0" to "10." Pain is described by selecting the facial expression depicting the degree of perceived pain. This scale will be assessed independently by the child, a parent who is present and observes the child's behavior, and the same nurse who is independent of the study.
Pain levels of the children will be evaluated 1 minute after the procedure.
Comparison of the fear score values of the groups
Time Frame: Children's fear levels will be evaluated first 1 minutes before the procedure.
The Children's Fear Scale (CFS) is used to measure the child's fear level. This scale is a one-item self-report measure for measuring pain-related fear in children. The CFS is a scale from 0 to 4, showing 5 facial expressions ranging from a neutral expression (0 = no anxiety) to a frightened face (4=severe anxiety). CFS is administered by the researcher to the children to assess their fear levels before and after the IM procedure.
Children's fear levels will be evaluated first 1 minutes before the procedure.
Comparison of the fear score values of the groups
Time Frame: Children's fear levels will be evaluated 1 minutes after the procedure.
The Children's Fear Scale (CFS) is used to measure the child's fear level. This scale is a one-item self-report measure for measuring pain-related fear in children. The CFS is a scale from 0 to 4, showing 5 facial expressions ranging from a neutral expression (0 = no anxiety) to a frightened face (4=severe anxiety). CFS is administered by the researcher to the children to assess their fear levels before and after the IM procedure.
Children's fear levels will be evaluated 1 minutes after the procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Yalova

Investigators

  • Study Director: Duygu Demir, Assis. Prof., Director
  • Principal Investigator: Derya Kılıç, Assis. Prof., Researcher

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2023

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

April 30, 2024

Study Registration Dates

First Submitted

March 12, 2024

First Submitted That Met QC Criteria

April 8, 2024

First Posted (Actual)

April 9, 2024

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • duygudemirr

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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