Technology-Based Distractions for Minor Procedures

Not Applicable

Not yet recruiting

• Conditions: Anxiety; Procedural Anxiety

• Registration Number: NCT06924814
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-04
• Study First Submitted QC: 2025-04-04
• Last Update Submitted: 2025-04-04
• Study First Posted: 2025-04-11
• Last Update Posted: 2025-04-11
• Study Start: 2025-06-01
• Primary Completion: 2026-05-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Evaluate the effectiveness of technological interventions on anxiety levels in patients who undergo minor procedures	baseline, immediately after the intervention	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".

Secondary Outcome Measures

Name	Time	Method
To evaluate the patient's cooperation during the intervention using the modified Induction Compliance Checklist (mICC)	during minor procedure	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.
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	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
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	The NRPS quantifies pain intensity on a scale from 0, being no pain, to 10, being the worst imaginable pain.
To evaluate patient's, clinician's, and caregiver's satisfaction levels	immediately after the intervention	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.
To evaluate the patient's affect during the intervention using HRAD	during minor procedure	HRAD contains 5-item scale assessing participant's affective state; happy, relaxed, anxious, distressed, with a yes/no answer to cooperation.

Trial Locations

Locations (1)

Lucile Packard Children's Hospital Stanford; 🇺🇸 Palo Alto, California, United States