Use of Virtual Reality Game Playing During Venipuncture

NCT ID: NCT03518346

Last Updated: 2019-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-09
• Study Completion Date: 2019-01-15

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.

Conditions

Autism; Development Delay; Typical Development

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Virtual Reality

Intervention Type: BEHAVIORAL

Samsung VR Go (VR head set), Samsung S7 (phone), and programmed distraction

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.

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: BEHAVIORAL

Books, movies, TV

Interventions

Virtual Reality

Samsung VR Go (VR head set), Samsung S7 (phone), and programmed distraction

Intervention Type: BEHAVIORAL

Standard of Care

Books, movies, TV

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julie Schweitzer, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

University of California Davis MIND Institute

Sacramento, California, United States

Countries

United States

Other Identifiers

1170355

Identifier Type: -

Identifier Source: org_study_id