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

NCT06354608 | Completed

• 1 other identifier: duygudemirr
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Audio Book; Vibration; Intramuscular Injection; pediatric emergency; Child; pain; fear

Outcome Measures

Primary Outcomes (3)

• Comparison of the pain score values of the groups Pain assesed by Wong-Baker FACES

  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

  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

  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.

Study Arms (3)

Audio Book Group

EXPERIMENTAL

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

Local Vibration Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

Interventions

Audio Book Group BEHAVIORAL

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.

Audio Book Group

Local Vibration Group DEVICE

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.

Local Vibration Group

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Yalova: lead

Study Sites (1)

University of Yalova

Yalova, Yalova, Turkey (Türkiye)

Location

Related Publications (5)

• McMurtry CM, Noel M, Chambers CT, McGrath PJ. Children's fear during procedural pain: preliminary investigation of the Children's Fear Scale. Health Psychol. 2011 Nov;30(6):780-8. doi: 10.1037/a0024817. Epub 2011 Aug 1.

  PMID: 21806301 RESULT

• Gerceker GO, Binay S, Bilsin E, Kahraman A, Yilmaz HB. Effects of Virtual Reality and External Cold and Vibration on Pain in 7- to 12-Year-Old Children During Phlebotomy: A Randomized Controlled Trial. J Perianesth Nurs. 2018 Dec;33(6):981-989. doi: 10.1016/j.jopan.2017.12.010. Epub 2018 Mar 17.

  PMID: 29559294 RESULT

• Ozalp Gerceker G, Ayar D, Ozdemir EZ, Bektas M. Effects of virtual reality on pain, fear and anxiety during blood draw in children aged 5-12 years old: A randomised controlled study. J Clin Nurs. 2020 Apr;29(7-8):1151-1161. doi: 10.1111/jocn.15173. Epub 2020 Jan 22.

  PMID: 31889358 RESULT

• Sivri Bilgen B, Balci S. The Effect on Pain of Buzzy(R) and ShotBlocker(R) during the Administration of Intramuscular Injections to Children: A Randomized Controlled Trial. J Korean Acad Nurs. 2019 Aug;49(4):486-494. doi: 10.4040/jkan.2019.49.4.486.

  PMID: 31477677 RESULT

• Sunitha Suresh BS, De Oliveira GS Jr, Suresh S. The effect of audio therapy to treat postoperative pain in children undergoing major surgery: a randomized controlled trial. Pediatr Surg Int. 2015 Feb;31(2):197-201. doi: 10.1007/s00383-014-3649-9. Epub 2015 Jan 3.

  PMID: 25555856 RESULT

MeSH Terms

Conditions

Pain, Procedural; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Duygu Demir, Assis. Prof.

  Director

  STUDY DIRECTOR

• Derya Kılıç, Assis. Prof.

  Researcher

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This study is an experimental, parallel-group (intervention-control), randomized controlled design

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: April 9, 2024
• Study Start: October 25, 2023
• Primary Completion: June 21, 2024
• Study Completion: July 1, 2024
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)