Technology-Based Distractions for Minor Procedures

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT06924814
Status
Not Yet Recruiting

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Conditions

  • Anxiety
  • Procedural Anxiety

Eligibility Criteria

Sex
ALL
Age
4 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Standard of Care — BEHAVIORAL
    Participant is allowed to use what they will use as a distraction tool while they are receiving treatment.
  • Immersive technology — BEHAVIORAL
    Participants will be randomly assigned to one of the following four groups; VR headsets, a bluetooth haptic device (Buddy Guard), a screen and projector (BERT), and a tablets with a game. Participant's anxiety will be assessed and pre- and post-intervention assessments will be completed.

Study Details

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.

Key Dates

Start date
May 1, 2026
Status verified
Mar 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: Standard of Care group
    No immersive technology will be assigned to the participant. Participant will use their own distraction method.
  • Experimental: Immersive Technology grorup
    Immersive technologies including VR headsets, a bluetooth haptic device (Buddy Guard), a screen and projector (BERT), and a tablets with a game will be randomly assigned to the participants. Each participant will receive one technological intervention.

Primary Outcome Measure

Evaluate the effectiveness of technological interventions on anxiety levels in patients who undergo minor procedures [ Time Frame: baseline, immediately after the intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Lucile Packard Children's Hospital StanfordPalo AltoCalifornia94304-

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Lucile Packard Children's Hospital Stanford· Palo Alto, CA

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