Use of Virtual Reality Game Playing During Venipuncture

NCT03518346 | Completed

• 1 other identifier: 1170355
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism; Development Delay; Typical Development

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Blood volume

  2 years. Collected once on each participant: immediately following injection

• Pain Scale

  2 years. Collected once on each participant: immediately following injection

• Satisfaction Survey

  2 years. Collected once on each participant: immediately following injection

• Fear Scale

  2 years. Collected twice on each participant: before and immediately following injection

• Time to Achieve Optimal Blood Volume

  2 years. Collected on each participant: during venipuncture procedure

Study Arms (2)

Virtual Reality Group

EXPERIMENTAL

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

Standard of Care Group

ACTIVE COMPARATOR

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

Interventions

Virtual Reality BEHAVIORAL

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

Virtual Reality Group

Standard of Care BEHAVIORAL

Books, movies, TV

Standard of Care Group

Eligibility Criteria

• Age: 8 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Participants aged 8-19 years old that are receiving a blood draw as part of their ReCHARGE evaluation
• History of distress or refusal of blood draws or similar medical procedures OR
• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California Davis MIND Institute

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Autistic Disorder; Learning Disabilities

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Julie Schweitzer, PhD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2018
• First Posted: May 8, 2018
• Study Start: April 9, 2018
• Primary Completion: January 15, 2019
• Study Completion: January 15, 2019
• Last Updated: May 15, 2019

Record last verified: 2019-05

Locations

US (1)