Technology-Based Distractions for Minor Procedures

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.

Study Overview

• Status: Withdrawn
• Conditions: Anxiety; Procedural Anxiety
• Intervention / Treatment: Behavioral: Standard of Care; Behavioral: Immersive technology

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Lucile Packard Children's Hospital Stanford

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care group; No immersive technology will be assigned to the participant. Participant will use their own distraction method.	Behavioral: Standard of Care; Participant is allowed to use what they will use as a distraction tool while they are receiving treatment.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the effectiveness of technological interventions on pain levels in patients whose age is 4-11 years old and undergo minor procedures	The FSP-R is a self-report measure of pain intensity displaying six faces representing equal intervals between the scale values from least pain = 0 to most pain = 10	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.	The NRPS quantifies pain intensity on a scale from 0, being no pain, to 10, being the worst imaginable pain.	baseline, immediately after the intervention
To evaluate patient's, clinician's, and caregiver's satisfaction levels	To analyze the patient's, clinician's, and caregiver's satisfaction levels, the feedback in the satisfaction survey at the end will be evaluated. The purpose of this analysis is to provide qualitative data on which aspects of the technological intervention the patient received mattered the most to the patient, clinician, and caregiver.	immediately after the intervention
To evaluate the patient's affect during the intervention using HRAD	HRAD contains 5-item scale assessing participant's affective state; happy, relaxed, anxious, distressed, with a yes/no answer to cooperation.	during minor procedure
To evaluate the patient's cooperation during the intervention using the modified Induction Compliance Checklist (mICC)	The mICC score will be recorded by the trained research observers during the minor procedure.11 behaviors that are commonly observed preoperatively will be recorded. Perfect compliance (score of 0) was compared to those that lacked cooperation. mICC will be rated at the time of intervention and only requires one RA.	during minor procedure

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: April 4, 2025
• First Submitted That Met QC Criteria: April 4, 2025
• First Posted (Actual): April 11, 2025

Study Record Updates

• Last Update Posted (Actual): August 18, 2026
• Last Update Submitted That Met QC Criteria: August 16, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Pain
• Additional Relevant MeSH Terms: Neurologic Manifestations; Mental Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Anxiety Disorders; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: 80120

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No