Technology-Based Distractions for Minor Procedures

NCT ID: NCT06924814

Last Updated: 2025-07-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-15
• Study Completion Date: 2026-07-15

Brief Summary

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.

Conditions

Anxiety; Procedural Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Standard of Care group

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

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: BEHAVIORAL

Participant is allowed to use what they will use as a distraction tool while they are receiving treatment.

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.

Group Type: EXPERIMENTAL

Immersive technology

Intervention Type: 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.

Interventions

Standard of Care

Participant is allowed to use what they will use as a distraction tool while they are receiving treatment.

Intervention Type: BEHAVIORAL

Immersive technology

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Thomas Caruso

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Lucile Packard Children's Hospital Stanford

Palo Alto, California, United States

Countries

United States

Central Contacts

Thomas Caruso, MD, PhD

Role: CONTACT

tjcaruso@stanford.edu

6504970927

Man Yee Suen, MMedSc

Role: CONTACT

smy822@stanford.edu

6504970927

Other Identifiers

80120

Identifier Type: -

Identifier Source: org_study_id