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

July 9, 2025 updated by: Sarah E Rebstock, University of Texas Southwestern Medical Center

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  1. After the potential participants signed informed consent and were screened for the ability to participate in the study at a treatment appointment.
  2. They then came to their cancer center (CCBD) appointment for port access for chemotherapy and were randomized to the Virtual Reality (VR) distraction group first, OR the Non-Virtual Reality (Non-VR) Distraction group first.
  3. At this CCBD visit, they then participated in their port needle access as part of standard of care for their cancer treatment using either VR or non-VR distraction for anxiety mitigation, depending on randomization, and were observed during the needle access with the Modified Yale Pre-procedural Anxiety Scale (mYPAS) to assess anxiety during the needle access procedure. The mYPAS is an objective, validated, observational anxiety assessment tool.
  4. In addition, parents were asked subjective questions as to how they thought their child tolerated Port needle access with the VR versus Non-VR accordingly.
  5. The study personnel then asked when their next potential cancer center appointment for port access to schedule participation in the second arm according to their randomization stratification. In this way, each study participant served as their own control.
  6. At the next possible port needle access appointment, they were once again observed using the mYPAS scale for the 2nd port access, with either VR or Non-VR distraction, depending on initial randomization group.
  7. Parents were once again asked subjective questions as to how they thought their child tolerated Port needle access with the VR versus Non-VR accordingly.
  8. The participants data could Only be included in the study if they participated in both study arms to completion.

Study Type

Interventional

Enrollment (Actual)

89

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75390
        • Kiley Poppino

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 played during port needle access.
Other Names:
  • Kind VR game

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preoperative Anxiety Score in Pediatric Oncology Patients
Time Frame: 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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Parents or Legally Authorized Representative (LAR) Who Subjectively Report Decreased Anxiety With the Use of VR
Time Frame: 2 years
Number of parents or legally authorized representative (LAR) who subjectively report decreased anxiety in their kids (participants in this study) 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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2021

Primary Completion (Actual)

May 14, 2024

Study Completion (Actual)

May 14, 2024

Study Registration Dates

First Submitted

October 22, 2021

First Submitted That Met QC Criteria

October 22, 2021

First Posted (Actual)

October 26, 2021

Study Record Updates

Last Update Posted (Actual)

July 11, 2025

Last Update Submitted That Met QC Criteria

July 9, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU-2020-0607

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

General information

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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