Treatment of Parental Anxiety Virtual Reality (VR)

Not Applicable

Recruiting

• Conditions: Anxiety; Virtual Reality; Parents

• Registration Number: NCT05729347
• Lead Sponsor: Stanford University

Brief Summary

The purpose of this study is to determine if non-invasive distracting devices (Virtual Reality headset) are more effective than the standard of care (i.e., no technology based distraction) for preventing anxiety in parental and pediatric populations

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-06
• Study First Submitted QC: 2023-02-06
• Study First Posted: 2023-02-15
• Study Start: 2023-06-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-17
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Ages 18-99 (Patient's parents will be enrolled)
• Able to consent

Exclusion Criteria

• People who do not consent
• Significant Cognitive Impairment
• History of Severe Motion Sickness
• Current Nausea
• Seizures
• Visual Problems Patients whose children are clinically unstable or require urgent/emergent intervention

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Procedural-Related Anxiety	Duration of intervention, approximately 20-30 minutes	Validated questionnaires regarding anxiety will be administers pre- and post-intervention (i.e virtual reality) and compared to those in the control arm (i.e no virtual reality)

Secondary Outcome Measures

Name	Time	Method
State-Trait Anxiety Inventory	baseline, immediately after the intervention	The State-Trait Anxiety Inventory (STAI) is a validated self-report questionnaire consisting of two subscales that measure state anxiety (temporary condition) and trait anxiety (general tendency). Each subscale contains 20 items rated on a 4-point Likert scale. Scores range from 20 to 80 per subscale, with higher scores indicating greater anxiety.
Device satisfaction	immediately after intervention	To evaluate the overall impact of device satisfaction, participants will complete the self-developed satisfaction survey. Participants will rank each factor on a Likert scale from 1 = not at all to 5 = a lot.
Modified Pain Catastrophizing Scale	immediately after intervention	Modified Pain Catastrophizing Scale(PCS); It is a self-report measure adapted from the Adult Pain Catastrophizing Scale used to assess negative thinking associated with pain. It contains 3 items rated on a 5-point scale ranging from 0 = "not at all" to 4 = "very much".
Change in anxiety levels	baseline, immediately after the intervention	Anxiety level measured by a Visual Analogue Scale - Anxiety (VAS-A) ranging from 0-10. Scale ranges from 0-10, with higher scores indicating higher anxiety levels.

Trial Locations

Locations (1)

Lucile Parkard Children's Hospital; 🇺🇸 Stanford, California, United States