Autism, Development Delay, Typical Development
Conditions
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.
Interventions
BEHAVIORALVirtual Reality
Samsung VR Go (VR head set), Samsung S7 (phone), and programmed distraction
BEHAVIORALStandard of Care
Books, movies, TV
Sponsors
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 19 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Blood volume | 2 years. Collected once on each participant: immediately following injection | Volume of blood collected in mL |
| 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 |
| 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 |
| 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 |
| Time to Achieve Optimal Blood Volume | 2 years. Collected on each participant: during venipuncture procedure | Time in minutes |
Countries
United States
Outcome results
None listed