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OpenTrials
Completed

NCT Number: NCT03518346

Use of Virtual Reality Game Playing During Venipuncture

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.

Completed

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Key information

Conditions

Autism Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Communication Disorders Development Delay Learning Disabilities Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Typical Development

Age range

8 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California Davis MIND Institute

Sacramento, California, 95817, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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

  • 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.

Treatment and study plan

Virtual reality

Behavioral

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

Standard of Care

Behavioral

Books, movies, TV

Primary outcomes

  1. Attempting vs. Refusing Venipuncture

    Time frame: 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 outcomes

  1. Blood volume

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

    Volume of blood collected in mL

  2. Pain Scale

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 2 years. Collected on each participant: during venipuncture procedure

    Time in minutes

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 8, 2018
Registry last updated
May 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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