Technology-Based Distractions During Minor Procedures

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Stanford University

Status

Completed

Conditions

Procedural Anxiety
Anxiety
Pain

Treatments

Behavioral: Use of Virtual Technology

Study type

Interventional

Funder types

Other

Identifiers

NCT03628989
46917

Details and patient eligibility

About

The purpose of this study is to determine if non-invasive distracting devices (Virtual Reality headset, Augmented Reality Headset) are more effective than the standard of care (i.e., no technology-based distraction) for decreasing anxiety and pain scores in pediatric patients undergoing various minor procedures (i.e lumbar punctures and cardiac catheterization). The anticipated primary outcome will be a reduction of overall cumulative medication and secondary outcomes include but are not limited to: physician satisfaction, discharge time, pain scores, anxiety scores, and procedure time.

Enrollment

58 patients

Sex

All

Ages

Under 17 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Age 17 and under
  • Able to consent or have parental consent
  • Undergoing minor procedures (i.e lumbar punctures, cardiac catheterization) at Lucile Packard Children's Hospital (LPCH) or Stanford Hospital facilities

Exclusion criteria

  • People who do not consent
  • Significant Cognitive Impairment
  • History of Severe Motion Sickness
  • Current Nausea
  • Seizures
  • Visual Problems
  • Non-English Speaking
  • Patients who clinically unstable or requires urgent/emergent intervention
  • (ASA) Physical status classification class 4 or higher
  • Patient or parental preference for General Anesthesia

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

58 participants in 3 patient groups

Cardiac Cathertization Patients
Experimental group
Description:
Participants will use technology based distraction during procedure.
Treatment:
Behavioral: Use of Virtual Technology
Allergy Patients
Experimental group
Description:
Participants will use technology based distraction during procedure
Treatment:
Behavioral: Use of Virtual Technology
Procedure-Only Patients
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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