Comparing Virtual Reality (VR) to Non-VR for Decreasing Preoperative/Procedural Anxiety

Sponsor

University of Texas Southwestern Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05094141

Collaborator

(none)

Enrollment

Location

Arms

35.5

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of the study is to utilize the modified Yale Preoperative Anxiety scale (mYPAS), a validated preoperative/procedural anxiety score, to measure preoperative anxiety via distraction in pediatric oncology patients undergoing port access.

The hypothesis is that using Virtual Reality (VR) will objectively decrease anxiety scores measured by mYPAS by five percent (primary outcome).

The secondary outcome will be the parents or the legally authorized representative (LAR) subjective reports of anxiety with the use of VR.

The Kind VR device is used in house at Children's Health in the Dallas and Plano campuses. The VR device used in this study qualifies as exempt from FDA IDE regulations. It is a non-significant risk, non-invasive, interactive video device the user wears like goggles. The study carries minimal risks to the subjects and is designed to minimize patient discomfort from placement or motion sickness. Furthermore, the device has disposable covers for protection against infection and can be sanitized between uses, once the disposable covers are removed. Children's Health System of Texas (CHST) and this research group are not partnering entities with the Kind VR, and the Kind VR device is not being studied. The effect of virtual reality (VR) on preprocedural anxiety as measured by questionnaires and the observations of the modified Yale Preoperative Anxiety Scale (mYPAS) is being studied

Most patients coming to the Clinic of Cancer and Blood Disorders (CCBD) are under chronic care for their ongoing disease and are likely to be coming to the CCBD at least twice in a 6-month period. The CCBD schedule will be reviewed by the researchers for patients age 5-12, requiring port access at least twice during the next six-month period. Patient families whose child meets the basic screening criteria, and have no exclusion criteria, will be approached privately as possible participants in the study. Up to 100 subjects will be enrolled over a 2-year period. Once the subject/parent or LAR agrees to participate, study staff will randomize the subjects into which standard of care distraction method for anxiety management they will receive first in this study.

Condition or Disease	Intervention/Treatment	Phase
Preoperative Anxiety	Other: Virtual reality	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

77 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Cross over study will be performed. Subjects will be randomized (1 to 1 randomization) at their initial encounter to either VR or Non-VR. During their second visit patients will be given the alternative mode of care (i.e. patients who initially received VR distraction will be given Non-VR distraction, and patients who initially received Non- VR distraction will receive VR distraction)Cross over study will be performed. Subjects will be randomized (1 to 1 randomization) at their initial encounter to either VR or Non-VR. During their second visit patients will be given the alternative mode of care (i.e. patients who initially received VR distraction will be given Non-VR distraction, and patients who initially received Non- VR distraction will receive VR distraction)

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Randomized Pilot Crossover Study Comparing Virtual Reality (VR) and Non-VR Distraction for Decreasing Preoperative/Procedural Anxiety as a Function of the Modified Yale Preoperative Anxiety Scale (mYPAS)

Actual Study Start Date :

Jan 13, 2021

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Non-VR (Virtual reality) The patient is not assigned to play the VR game. mYPAS scoring for port access is done.
Experimental: VR (Virtual Reality) The patient is assigned to play the VR game for 15 minutes prior to actual port access procedure start. mYPAS scoring while playing VR device for Port access	Other: Virtual reality Virtual reality game

Arm

Intervention/Treatment

No Intervention: Non-VR (Virtual reality)

The patient is not assigned to play the VR game. mYPAS scoring for port access is done.

Experimental: VR (Virtual Reality)

The patient is assigned to play the VR game for 15 minutes prior to actual port access procedure start. mYPAS scoring while playing VR device for Port access

Other: Virtual reality

Virtual reality game

Outcome Measures

Primary Outcome Measures

Preoperative anxiety score in pediatric oncology patients [2 years]
Preoperative anxiety score in pediatric oncology patients as measured by modified Yale Preoperative Anxiety Scale (mYPAS), a validated preoperative/procedural anxiety score. Possible scores range from 23 to 100. Higher score values are correlated with increased preoperative anxiety.
Number of parents or legally authorized representative (LAR) who subjectively report decreased anxiety with the use of VR [2 years]
Number of parents or legally authorized representative (LAR) who subjectively report decreased anxiety with the use of VR (Virtual Reality) would be calculated based on Parents' questionnaires scored and evaluated for subjective improvement in parental assessment of preoperative anxiety.

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Any patient of the Children's Medical Center CCBD
5-12 years of age
Patient requiring their port accessed twice or more within a 6 months period
Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria

Subjects younger than 5 and older than 12
Patients requiring recovery in PICU or sites other than PACU
If parents or subject is not willing to participate
Subjects with severe developmental delays and subjects with developmental challenges preventing them from keeping the VR device on are also excluded
Patients who will not be in CCBD for port access at least twice in 6 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UT Southwestern	Dallas	Texas	United States	75390

Sponsors and Collaborators

University of Texas Southwestern Medical Center

Investigators

Principal Investigator: Sarah Rebstock, MD, UT Southwestern
Principal Investigator: Neethu Chandran, UT Southwestern

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sarah E Rebstock, Associate Professor, University of Texas Southwestern Medical Center

ClinicalTrials.gov Identifier:

NCT05094141

Other Study ID Numbers:

STU-2020-0607

First Posted:

Oct 26, 2021

Last Update Posted:

Oct 26, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Sarah E Rebstock, Associate Professor, University of Texas Southwestern Medical Center

virtual reality

preoperative anxiety

modified Yale Preoperative Anxiety Scale

Additional relevant MeSH terms:

Anxiety Disorders

Study Results

No Results Posted as of Oct 26, 2021