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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    77
  • sponsor
    University of Texas Southwestern Medical Center
Updated on 3 November 2021
Accepts healthy volunteers

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.

Details
Condition Preoperative Anxiety
Treatment Virtual Reality
Clinical Study IdentifierNCT05094141
SponsorUniversity of Texas Southwestern Medical Center
Last Modified on3 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Any patient of the Children's Medical Center CCBD
-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
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