Effect of Virtual Reality on Child Pain

NCT04950478 | Completed DMC

• 1 other identifier: Virtual Reality use on Pain
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized controlled experimental study conducted to determine effect of using virtual reality headset during venipuncture on pain level, heart rate and oxygen saturation values among 7-12 year-old children. The data were collected from 102 children coming to vaccination room of an university hospital's pediatric outpatient clinic. Before the venipuncture, state anxiety scores of children in both groups were evaluated. The children in experimental group wore virtual reality headset during the venipuncture. The children in control group were subjected to standard venipuncture procedure. Before, during and after the venipuncture, pulse and oxygen saturation values were measured.

Conditions

Pain

Keywords

child; nursing; pain management; venipuncture; Virtual reality

Outcome Measures

Primary Outcomes (1)

• Pain Severity

  The children were informed about the Faces Pain Scale-Revised (FPS-R) and they were asked to mark the children's pain levels on the scale before and after the venipuncture procedure. In addition, the pain levels of the children before and after the procedure were determined by the researcher who is a specialist in pediatric nursing by using the same scales.

  Between 5-10 minutes

Secondary Outcomes (2)

• Heart Rate

  Between 5-10 minutes

• Oxygen Saturation

  Between 5-10 minutes

Study Arms (2)

Virtual Reality

EXPERIMENTAL

The children wore the virtual reality headset and game was started one minute before the venipuncture. The children took off the virtual reality headset after the venipuncture ended.

Other: Virtual Reality

Control Group

NO INTERVENTION

No intervention was performed to reduce pain in the control group

Interventions

Virtual Reality OTHER

5 minutes before the procedure, they were recorded on 'Child and Parent Information Form', State-Trait Anxiety Inventory for Children and FPS-R. Their heart rate and oxygen saturation values were read and recorded. Children wore the virtual reality headset and game was started one minute before the venipuncture. As soon as the injector inserted, the researcher turned on a stopwatch and read and recorded heart rate and oxygen saturation values. When the injector was removed, the researcher stopped the stopwatch and recorded the duration of the procedure.When the injector was removed, the stopwatch was stopped and heart rate and oxygen saturation were recorded. The children took off the virtual reality headset and were asked to evaluate their pain level through FPS-R and their responses were recorded.

Virtual Reality

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 7-12 who agreed to participate in the study by giving written and verbal consent,
• Parents who agreed to participate in the study verbally and in written by signing informed consent form,
• Body temperature within normal values for children (36.5- 37.2 oC),
• Children who were healthy and for whom the doctor requested a blood test for general control.
• Children who were healthy in sensory and neurologic aspects.

You may not qualify if:

• Having any chronic disease or any disease causing pain in children,
• Having hearing, mental or neurological disability in children,
• Having history of syncope during previous venipuncture procedures for the children,
• Having visual impairment in children,
• Unsuccessful venipuncture procedure in the first attempt.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpaşa Florence Nightingale Faculty of Nursing

Istanbul, 34093, Turkey (Türkiye)

Location

Related Publications (1)

• Orhan E, Gozen D. The Effect of Virtual Reality on Pain Experienced by School-Age Children During Venipuncture: A Randomized Controlled Study. Games Health J. 2023 Aug;12(4):330-339. doi: 10.1089/g4h.2022.0232.

  PMID: 37466456 DERIVED

MeSH Terms

Conditions

Pain; Agnosia

Condition Hierarchy (Ancestors)

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

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, Educator Nurse

Study Record Dates

• First Submitted: June 29, 2021
• First Posted: July 6, 2021
• Study Start: May 1, 2018
• Primary Completion: May 15, 2019
• Study Completion: May 30, 2019
• Last Updated: July 6, 2021

Record last verified: 2021-06

Locations

TU (1)