The Effect of Virtual Reality on Pain, Fear and Anxiety by Children During Venipuncture

NCT06727149 | Completed DMC

• 1 other identifier: 02082022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

There are many approaches to reduce pain, fear and anxiety that may occur in children during invasive procedures. The most commonly used of these approaches is virtual reality, which is a method of distracting attention and designed with cognitive and behavioral techniques. This study was conducted in a randomized controlled experimental design to determine the effect of virtual reality glasses given to children during venepuncture on pain, fear and anxiety. The research was conducted between September 2022 and May 2023 with two parallel groups in the pediatric inpatient service of a private hospital in western Turkey. The study sample consisted of children aged 6-12 years and the sample was randomization, the control group (n=30) and the virtual training group (30) constituted a total of 60. The data of the study were obtained from Child Information Form, Wong-Baker Faces Pain Rating Scale, State-Trait Anxiety Inventory for children. The data were analyzed using SPSS 25 program.

Conditions

Pain; Fear; Anxiety

Keywords

pain management; pain in children; fear in children; anxiety; virtual reality

Outcome Measures

Primary Outcomes (1)

• pain severity

  The children and parents informed about Wong BakerFaces Pain

  8 month

Secondary Outcomes (2)

• Fear levels

  8 month

• Anxiety levels

  8 month

Study Arms (2)

Control Group (Standard Procedure)

EXPERIMENTAL

Other: Control Group

Virtual Reality Group

EXPERIMENTAL

Other: Virtual Reality Group

Interventions

Control Group OTHER

No intervention was performed to reduce pain, fear and anxiety in the control group

Control Group (Standard Procedure)

Virtual Reality Group OTHER

The children in the VR group were informed about the virtual reality glasses and told that they could remove the glasses at any time if they felt uncomfortable during the procedure

Also known as: Experimental

Virtual Reality Group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The children
• who were aged between 6-12 years
• were healty
• stable hemodynamics who were undergoing venipuncture
• who were sufficient cognitive and communication abilities to rate their pain, fear, and anxiety levels,
• were willing to participate. All participating children gave verbal consent to participate, and their families provided written consent

You may not qualify if:

• Children with unstable conditions and vital signs, intubated, had visual problems or did not want to participate in the study were excluded.

Sponsors & Collaborators

• University of Beykent: lead

Study Sites (1)

Istanbul Beykent University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders; Agnosia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Hamiyet Kızıl, Phd RN

  Istanbul Beykent University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD RN Assistant Professor Hamiyet KIZIL

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 10, 2024
• Study Start: September 1, 2022
• Primary Completion: November 1, 2022
• Study Completion: May 1, 2023
• Last Updated: December 10, 2024

Record last verified: 2024-12

Locations

TU (1)