Use of Virtual Reality Game Playing During Venipuncture

Not Applicable

Completed

• Conditions: Development Delay; Typical Development; Autism
• Interventions: Behavioral: Virtual Reality; Behavioral: Standard of Care

• Registration Number: NCT03518346
• Lead Sponsor: University of California, Davis

Brief Summary

To evaluate the impact of using virtual reality, VR, game playing on successful completion and reduction of distress and pain in pediatric venipuncture, and to increase adherence in obtaining the desired blood volume.

Detailed Description

Participants will be randomly assigned using a random number generator to either the virtual reality condition, or to the standard procedure that includes using books and/or watching movies as a standard method of distraction.

Participants will take part in the study during their scheduled research venipuncture. The venipuncture lasts approximately 15-30 minutes. Pre and post venipuncture questionnaires for both participant and parent will take 15 minutes to complete. Total study time is between 30 and 45 minutes. Questionnaires completed by research personal will take 15 minutes to complete.

Study Timeline

• Study First Submitted: 2018-03-27
• Study Start: 2018-04-09
• Study First Submitted QC: 2018-05-04
• Study First Posted: 2018-05-08
• Primary Completion: 2019-01-15
• Study Completion: 2019-01-15
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-13
• Last Update Posted: 2019-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1. Participants aged 8-19 years old that are receiving a blood draw as part of their ReCHARGE evaluation
2. History of distress or refusal of blood draws or similar medical procedures OR
3. Parent or child endorsement of fear, anxiety, concern or adherence in past blood draw during the recruitment phone call, consent or child evaluation will be offered the potential of the VR intervention OR
4. Endorsement of anxiety or concerns with medical procedures on an in house phlebotomist blood draw screening form will also be used as inclusion criteria.

Exclusion Criteria

1. History of seizures.
2. Vision loss or significant visual impairment to the degree that the participant is unable to see the activity and features of the VR game.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual Reality Group	Virtual Reality	Participants may be randomized to the virtual reality, VR, group or the standard of care group. For the VR group, we are using the Samsung VR Go (VR head set), Samsung S7 (phone) and programmed distraction (Spaceburgers, Pebbles the Penguin, and/or Happy Place). Spaceburgers and Pebbles the Penguin were designed by the Department of Anesthesiology at Lucile Packard Children's Hospital Stanford through the Stanford Chariot Program (Childhood Anxiety Reduction Through Innovation and Technology). Happy Place is a nongame immersive experience that will be offered to children uninterested in the previously mentioned game. Happy Place was designed by a Swedish Pharmacy Chain, Apotek Hjartat, aimed to distract patients from their pain with a peaceful, interactive environment. Each of the video games runs for the length of time needed to complete the venipuncture.
Standard of Care Group	Standard of Care	Participants may be randomized to the virtual reality, VR, group or the standard of care group. The standard of care group will use various distractions. Distraction tools include books and movies using a wall mounted TV as standard practice.

Primary Outcome Measures

Name	Time	Method
Attempting vs. Refusing Venipuncture	2 years	Compare if the participant is willing to let us attempt the venipuncture or refuses the venipuncture. the number of patients will be counted.

Secondary Outcome Measures

Name	Time	Method
Satisfaction Survey	2 years. Collected once on each participant: immediately following injection	Child and Parent Satisfaction Survey consists of 5 questions with likert scale responses
Pain Scale	2 years. Collected once on each participant: immediately following injection	Pain scale measures patient reports of pain levels after venipuncture on scale of 0-10
Time to Achieve Optimal Blood Volume	2 years. Collected on each participant: during venipuncture procedure	Time in minutes
Blood volume	2 years. Collected once on each participant: immediately following injection	Volume of blood collected in mL
Fear Scale	2 years. Collected twice on each participant: before and immediately following injection	Child Fear scale measures patient reports of fear levels before and after venipuncture on scale of 0-4

Trial Locations

Locations (1)

University of California Davis MIND Institute; 🇺🇸 Sacramento, California, United States