The Effect of Virtual Reality On Pain and Anxiety During Blood Draw in Children: A Randomized Controlled Study

NCT05175924 | Completed

• 1 other identifier: Erzi̇ncanBinaliYildırim
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: The study was carried out to determine the effect of virtual reality applied during blood collection upon pain and anxiety in children aged 5-12. Design and Methods: In this randomized controlled study, children included in the sample group were assigned to the control group (n=43) and Aquarium VR group (n=45) using block randomization. "Child State Anxiety Scale " and "Wong-Baker Faces Pain Scale" were used to collect the data of the study. Children in the Aquarium VR group watched the "Aquarium VR" application through virtual reality glasses during the procedure. The children in the control group benefited from routine nursing services. The pain scores after blood collection and anxiety scores before and during blood collection in children in both groups were interpreted.

Conditions

Pain, Procedural; Children, Only

Keywords

Anxiety; Blood draw; Children; Nursing; Pain; Virtual reality

Outcome Measures

Primary Outcomes (1)

• Comparison of Wong-Baker Faces Pain Scale Mean Scores by Groups

  This scale measuring the severity of pain was used in children aged between 3-18 years. In this scale, pain was scored for facial expressions according to numerical values, and the numerical rating of the scale varied between 0 and 10. Facial expressions ranging from smiling (0=very happy/no pain) to crying (10=most painful) indicated emotions.

  Evaluated at the time of blood collection.

Secondary Outcomes (1)

• Comparison of Child Anxiety Scale Mean Scores before and during the procedure according to the groups

  Evaluated before and during blood collection.

Study Arms (1)

Virtual reality

EXPERIMENTAL

In the Aquarium VR group, virtual reality headset compatible with iPhone 7 (Apple) was used to distract attention. Before use, the headsets were tested on five children for face fit and visibility of the application used. Written and verbal consent of the children and their parents was obtained to test the headsets. The children who tested the headsets were not included into the study. The headset offered a soft and comfortable experience in contact with the skin due to its leather and pad covering. It also had a wide viewing angle and an optical zoom button. Due to its noise isolation function, it did not disturb anyone or make noise.

Other: Nanpharmacological method

Interventions

Nanpharmacological method OTHER

Virtual Reality

Virtual reality

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Must be between 5-12 years old
• There should be no pain before the blood draw procedure
• Should not have a chronic disease that will cause pain Blood should be taken from the antecubital region
• Must be willing to participate in the research

You may not qualify if:

• The transmission barrier
• Wearing glasses
• Involuntary

Sponsors & Collaborators

• Erzincan Binali Yildirim Universitesi: lead

Study Sites (1)

Gülsün Ayran

Merkez, Eyalet/Yerleşke, 24000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Procedural; Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asistant Professor

Model Details: It is a randomized controlled trial consisting of an experiment and a control group.

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: January 4, 2022
• Study Start: May 15, 2021
• Primary Completion: June 15, 2021
• Study Completion: July 31, 2021
• Last Updated: July 5, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)