Treatment of Parental Anxiety Virtual Reality (VR)

NCT ID: NCT05729347

Last Updated: 2025-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2025-12-31

Brief Summary

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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

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Conditions

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Anxiety Parents Virtual Reality

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Virtual Reality

Participants will be immersed in a virtual environment. Calming scenery will be shown via the headset for 20-30 minutes

Group Type EXPERIMENTAL

Virtual Reality headset with calming scenery

Intervention Type BEHAVIORAL

Participants will be immersed in a virtual environment. Calming scenery will be shown via the headset for 20-30 minutes

Control

No intervention (i.e. virtual reality headset) will be applied to the participant.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Virtual Reality headset with calming scenery

Participants will be immersed in a virtual environment. Calming scenery will be shown via the headset for 20-30 minutes

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Ages 18-99 (Parents whose children is hospitalized)
* Able to consent
* Parents whose child is undergoing various procedures at LPCH and Stanford Hospital and Clinics.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Thomas Caruso

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Lucile Parkard Children's Hospital

Stanford, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Thomas J Caruso, MD

Role: CONTACT

650-723-5728

Man Yee Suen, MMed

Role: CONTACT

6502240517

Facility Contacts

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Thomas J Caruso, MD, PhD

Role: primary

References

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Chang ZY, Kang GC, Koh EYL, Fong RJK, Tang J, Goh CK, Tan NC. Immersive Virtual Reality in Alleviating Pain and Anxiety in Children During Immunization in Primary Care: A Pilot Randomized Controlled Trial. Front Pediatr. 2022 Mar 25;10:847257. doi: 10.3389/fped.2022.847257. eCollection 2022.

Reference Type BACKGROUND
PMID: 35402359 (View on PubMed)

Other Identifiers

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69068

Identifier Type: -

Identifier Source: org_study_id

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