Technology-Based Distractions for Minor Procedures

NCT06924814 | Not Yet Recruiting

• 1 other identifier: 80120
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

Pain

Outcome Measures

Primary Outcomes (1)

• Evaluate the effectiveness of technological interventions on anxiety levels in patients who undergo minor procedures

  Participants will complete the Visual Analogue Scale for Anxiety (VAS-A), a self-report scale to measure anxiety levels before and after the technological intervention. The scale is a horizontal line from 0 to 10 with an anchor at 0 indicating "no anxiety" and an anchor at 10 indicating "worst possible anxiety".

  baseline, immediately after the intervention

Secondary Outcomes (5)

• Evaluate the effectiveness of technological interventions on pain levels in patients whose age is 4-11 years old and undergo minor procedures

  baseline, immediately after the intervention

• To evaluate pain levels pre- and post-intervention, participants will complete the Numerical Rating Pain Scale (NRPS) for patients 12-17 years old.

  baseline, immediately after the intervention

• To evaluate patient's, clinician's, and caregiver's satisfaction levels

  immediately after the intervention

• To evaluate the patient's affect during the intervention using HRAD

  during minor procedure

• To evaluate the patient's cooperation during the intervention using the modified Induction Compliance Checklist (mICC)

  during minor procedure

Study Arms (2)

Standard of Care group

ACTIVE COMPARATOR

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

Behavioral: Standard of Care

Immersive Technology grorup

EXPERIMENTAL

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.

Behavioral: Immersive technology

Interventions

Standard of Care BEHAVIORAL

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

Standard of Care group

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.

Immersive Technology grorup

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Lucile Packard Children's Hospital Stanford

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Pain

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Thomas Caruso, MD, PhD

CONTACT

6504970927; tjcaruso@stanford.edu

Man Yee Suen, MMedSc

CONTACT

6504970927; smy822@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: April 11, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

US (1)