Effect of the Format of a Video Game on Children's Experience During Venipuncture

NCT05065307 | Completed

• 1 other identifier: 2021-00979
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Anxiolysis and analgesia are of paramount importance when conducting medical procedures, particularly in children. Nonpharmacologic techniques such as distraction and hypnosis improve the patient experience when used in the correct setting and may reduce the need for medications and pharmacological sedation. Virtual reality immersion is a novel approach to anxiolysis and analgesia but the content (i.e. games) available on the market are limited in their appropriateness for age, and the lack of specific design for medical procedures. VRelief, designed using a multidisciplinary team of clinicians, hypnosis practitioners, psychologists and computer scientists specializing in the Multimodal Modelling of Emotion \& Feeling may present a safe and superior alternative to a similar game presented in a video tablet format, in mitigating procedural anxiety and pain and improving the patient experience during venipuncture.

Conditions

Pain, Procedural

Keywords

Hypnosis; Virtual Reality; Behavioral intervention; Venipuncture

Outcome Measures

Primary Outcomes (5)

• Child rating of maximum pain

  Visual Analog Scale rating of minimum 0 (least amount) and maximum 10 (most amount)

  during venipuncture

• Child rating of time spent thinking about pain

  Visual Analog Scale rating of minimum 0 (least amount) and maximum 10 (most amount)

  during venipuncture

• Child rating of anxiety

  Visual Analog Scale rating of minimum 0 (least amount) and maximum 10 (most amount)

  during venipuncture

• "Fun" rating

  Visual Analog Scale rating of minimum 0 (least amount) and maximum 10 (most amount)

  during venipuncture

• Parental rating of satisfaction

  Visual Analog Scale rating of minimum 0 (least amount) and maximum 10 (most amount)

  during venipuncture

Secondary Outcomes (6)

• Child rating of venipuncture unpleasantness

  during venipuncture

• Heart rate change during the venipuncture compared to the start of the procedure

  baseline, during the intervention, immediately after the intervention and 5 minutes later

• Number of persons required for physical and pharmacological restraint of children during these procedures

  during venipuncture

• Feeling of immersion into the game

  during venipuncture

• Parental anxiety

  during venipuncture

Study Arms (2)

Video game in Virtual reality

EXPERIMENTAL

The study subject will be playing a video game during the venipuncture, in virtual reality

Diagnostic Test: Venipuncture

Video game on a tablet

ACTIVE COMPARATOR

The study subject will be playing a video game during the venipuncture, on a tablet

Diagnostic Test: Venipuncture

Interventions

Venipuncture DIAGNOSTIC_TEST

Diagnostic venipuncture

Video game in Virtual reality; Video game on a tablet

Eligibility Criteria

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

You may qualify if:

• \- Children 5-12 undergoing a venipuncture as part of the Corona Immunitas Covid serology study

You may not qualify if:

• Parents prefer their child not to use screens
• Known or suspected light-sensitive epilepsy
• Moderate or severe intellectual disability
• Physical factors preventing placement of the VR headset (e.g.: wound on the face, etc.)
• Inability to understand or follow the procedures of the study due to a language barrie

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Geneva University Hospitals

Geneva, 1205, Switzerland

Location

Related Publications (1)

• Zavlanou C, Savary V, Mermet S, Sander D, Corradi-Dell'Acqua C, Rudrauf D, Tisserand Y, Sahyoun C. Virtual reality vs. tablet for procedural comfort using an identical game in children undergoing venipuncture: a randomized clinical trial. Front Pediatr. 2024 May 13;12:1378459. doi: 10.3389/fped.2024.1378459. eCollection 2024.

  PMID: 38803637 DERIVED

MeSH Terms

Conditions

Pain, Procedural

Interventions

Phlebotomy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Blood Specimen Collection; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Cyril Sahyoun, MD

  University Hospital, Geneva

  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: Deputy Chief

Study Record Dates

• First Submitted: August 13, 2021
• First Posted: October 4, 2021
• Study Start: June 21, 2021
• Primary Completion: July 3, 2021
• Study Completion: July 6, 2021
• Last Updated: November 9, 2022

Record last verified: 2022-11

Locations

CH (1)