Use of Virtual Reality Game Playing During Venipuncture

• Sponsor: University of California, Davis (Other)
• Overall Status: Completed
• CT.gov ID: NCT03518346
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arms: 2
• Actual Duration (Months): 9.2
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Autism; Development Delay; Typical Development	Behavioral: Virtual Reality; Behavioral: Standard of Care	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Use of Virtual Reality Game Playing During Venipuncture
• Actual Study Start Date: Apr 9, 2018
• Actual Primary Completion Date: Jan 15, 2019
• Actual Study Completion Date: Jan 15, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. Blood volume [2 years. Collected once on each participant: immediately following injection]

   Volume of blood collected in mL

2. 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

3. 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

4. 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

5. Time to Achieve Optimal Blood Volume [2 years. Collected on each participant: during venipuncture procedure]

   Time in minutes

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 19 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California Davis MIND Institute	Sacramento	California	United States	95817

Sponsors and Collaborators

• University of California, Davis

Investigators

• Principal Investigator: Julie Schweitzer, PhD, University of California, Davis

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of California, Davis
• ClinicalTrials.gov Identifier: NCT03518346
• Other Study ID Numbers: 1170355
• First Posted: May 8, 2018
• Last Update Posted: May 15, 2019
• Last Verified: May 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of May 15, 2019