Use of Virtual Reality Game Playing During Venipuncture

Autism Clinical Trial

Official title:

Use of Virtual Reality Game Playing During Venipuncture

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03518346
• Other study ID #: 1170355
• Status: Completed
• Phase: N/A
• Start date: April 9, 2018
• Est. completion date: January 15, 2019

Study information

• Verified date: May 2019
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 15, 2019
• Est. primary completion date: January 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 19 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism
• Development Delay
• Typical Development

Intervention

Behavioral:
• Virtual Reality
Samsung VR Go (VR head set), Samsung S7 (phone), and programmed distraction
• Standard of Care
Books, movies, TV

Locations

Country	Name	City	State
United States	University of California Davis MIND Institute	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Blood volume	Volume of blood collected in mL	2 years. Collected once on each participant: immediately following injection
Secondary	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
Secondary	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
Secondary	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
Secondary	Time to Achieve Optimal Blood Volume	Time in minutes	2 years. Collected on each participant: during venipuncture procedure