Technology-Based Distractions for Minor Procedures

Stanford University

Status: Begins enrollment in 1 month

Conditions: Procedural Anxiety; Anxiety

Treatments: Behavioral: Immersive technology; Behavioral: Standard of Care

Study type: Interventional

Funder types: Other

Identifiers

NCT06924814

80120

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: 200 estimated patients

Sex: All

Ages: 4 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pediatric patient age between 4-17
• English speaking
• Parental consent/patient assent
• Undergoing minor procedure(s) at LPCH or Stanford Hospital

Exclusion criteria

• Patient does not consent
• Legal guardian not present to obtain consent
• Patient with a significant neurological condition or major developmental disability
• Patient experiencing nausea
• Patient with active infection of the face or hand
• A history of severe motion sickness
• A history of visual problems
• A history of seizures caused by flashing light
• Major surgery within the last 48 hours
• Patients who are clinically unstable or require urgent/emergent intervention
• Patient or parental preference for general anesthesia

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Standard of Care group

Active Comparator group

Description:

No immersive technology will be assigned to the participant. Participant will use their own distraction method.

Treatment:

Behavioral: Standard of Care

Immersive Technology grorup

Experimental group

Description:

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.

Treatment:

Behavioral: Immersive technology