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Completed

NCT Number: NCT05094141

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

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.

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Key information

Conditions

Preoperative Anxiety

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kiley Poppino

Dallas, Texas, 75390, United States

About this study

  • After the potential participants signed informed consent and were screened for the ability to participate in the study at a treatment appointment.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • The participants data could Only be included in the study if they participated in both study arms to completion.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Reality

Other

Virtual reality game played during port needle access.

Other names: Kind VR game

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study 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)

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Oct 26, 2021
Registry last updated
Jul 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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