The Effect of Distraction Technique on Children's Pain, Anxiety and Fear of Medical Procedure in Invasive Interventions

The Effect of Distraction Technique on Children's Pain, Anxiety and Fear of Medical

This study was conducted on the effects of visual and/or auditory distraction techniques applied to children aged 7-12 years who applied to Çanakkale Mehmet Akif Ersoy State Hospital Gynecology and Pediatric Emergency Service during invasive procedures (blood sampling, intravenous access or intramuscular injection in the deltoid region). Kaleidoscope, music concert, virtual reality glasses) is a randomized controlled experimental study to determine the effect of children on pain, anxiety and fear of medical procedures.

Study Overview

• Status: Completed
• Conditions: Child Behavior
• Intervention / Treatment: Other: Kaleidoscope; Other: Music; Other: Virtual reality glasses

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Balıkesir
    • Bandırma, Balıkesir, Turkey
      • Banıdrma Onyedi Eylul University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The child is between the ages of 7 and 12
• Admission of the child to the pediatric emergency service for diagnosis and treatment
• The child's general condition is stable
• Deciding on one of the interventions such as blood collection, vascular access, deltoid region intramuscular injection after the examination, and the absence of any other invasive intervention planning
• The fact that the invasive intervention was performed in one go
• The child does not have vision and hearing problems
• The child has no pain (due to the disease, drug side effects, distension)
• The child does not have a chronic disease (kidney, diabetes, etc.) that will require frequent invasive procedures.
• The child's mental development level to be able to answer the questions asked
• The child and parent speak and understand Turkish comfortably
• The children and their parents are willing to participate in the research.
• Parents give written consent

Exclusion Criteria:

• The child has a history of epilepsy, vertigo and neurological disease
• Having a history of fainting during blood draw
• Having a disease that causes chronic pain
• Wearing glasses or hearing aids
• Complication development during invasive intervention (allergy, syncope, etc.)
• If the child is in danger of life and is taken to the very urgent patient examination room (resuscitation room)
• Deciding that the child is a forensic case after the examination

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Kaleidoscope	Other: Kaleidoscope; Kaleidoscope; Other: Music; Music; Other: Virtual reality glasses; Virtual reality glasses
Experimental: Music; Music listening	Other: Kaleidoscope; Kaleidoscope; Other: Music; Music; Other: Virtual reality glasses; Virtual reality glasses
Experimental: Virtual reality glasses	Other: Kaleidoscope; Kaleidoscope; Other: Music; Music; Other: Virtual reality glasses; Virtual reality glasses
No Intervention: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain level	Pain level	5 minutes before intervention
Pain level	Pain level	5 minutes after intervention
Anxiety level	Anxiety level	5 minutes before intervention
Anxiety level	Anxiety level	5 minutes after intervention
Fear of medical procedures	Fear of medical procedures	5 minutes before intervention
Fear of medical procedures	Fear of medical procedures	5 minutes after intervention

Collaborators and Investigators

• Sponsor: Bandırma Onyedi Eylül University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): November 1, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: August 17, 2022
• First Submitted That Met QC Criteria: September 5, 2022
• First Posted (Actual): September 9, 2022

Study Record Updates

• Last Update Posted (Actual): September 9, 2022
• Last Update Submitted That Met QC Criteria: September 5, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: music; Kaleidoscope; virtual reality glasses
• Other Study ID Numbers: BandirmaOnyediEylulUU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No