Use of Virtual Reality Game Playing During Venipuncture

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.

Study Overview

• Status: Completed
• Conditions: Autism; Development Delay; Typical Development
• Intervention / Treatment: Behavioral: Virtual Reality; Behavioral: Standard of Care

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • University of California Davis MIND Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality Group; 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.	Behavioral: Virtual Reality; Samsung VR Go (VR head set), Samsung S7 (phone), and programmed distraction
Active Comparator: Standard of Care Group; 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.	Behavioral: Standard of Care; Books, movies, TV

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of California, Davis

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2018
• Primary Completion (Actual): January 15, 2019
• Study Completion (Actual): January 15, 2019

Study Registration Dates

• First Submitted: March 27, 2018
• First Submitted That Met QC Criteria: May 4, 2018
• First Posted (Actual): May 8, 2018

Study Record Updates

• Last Update Posted (Actual): May 15, 2019
• Last Update Submitted That Met QC Criteria: May 13, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 1170355

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No