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Treatment of Parental Anxiety Virtual Reality (VR)

Primary Purpose

Anxiety, Parents, Virtual Reality

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality headset with calming scenery
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety

Eligibility Criteria

undefined - 99 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Lucile Parkard Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Virtual Reality

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

Procedural-Related Anxiety
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

Full Information

First Posted
February 6, 2023
Last Updated
July 2, 2023
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT05729347
Brief Title
Treatment of Parental Anxiety Virtual Reality (VR)
Official Title
Treatment of Parental Anxiety With Virtual Reality (VR): A Prospective, Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Parents, Virtual Reality

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality
Arm Type
Experimental
Arm Description
Participants will be immersed in a virtual environment. Calming scenery will be shown via the headset for 20-30 minutes
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention (i.e. virtual reality headset) will be applied to the participant.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality headset with calming scenery
Intervention Description
Participants will be immersed in a virtual environment. Calming scenery will be shown via the headset for 20-30 minutes
Primary Outcome Measure Information:
Title
Procedural-Related Anxiety
Description
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)
Time Frame
Duration of intervention, approximately 20-30 minutes

10. Eligibility

Sex
All
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas J Caruso, MD
Phone
650-723-5728
Email
tjcaruso@stanford.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Man Yee Suen, MMed
Phone
6502240517
Email
msuen@stanfordchildrens.org
Facility Information:
Facility Name
Lucile Parkard Children's Hospital
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas J Caruso, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35402359
Citation
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.
Results Reference
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Treatment of Parental Anxiety Virtual Reality (VR)

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