ClinicalTrials.Veeva

Menu

Use of Virtual Reality Game Playing During Venipuncture

University of California (UC) Davis logo

University of California (UC) Davis

Status

Completed

Conditions

Development Delay
Typical Development
Autism

Treatments

Behavioral: Virtual Reality
Behavioral: Standard of Care

Study type

Interventional

Funder types

Other

Identifiers

NCT03518346
1170355

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 patients

Sex

All

Ages

8 to 19 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

12 participants in 2 patient groups

Virtual Reality Group
Experimental group
Description:
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.
Treatment:
Behavioral: Virtual Reality
Standard of Care Group
Active Comparator group
Description:
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.
Treatment:
Behavioral: Standard of Care

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems