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History of Changes for Study: NCT05094141
Comparing Virtual Reality (VR) to Non-VR for Decreasing Preoperative/Procedural Anxiety
Latest version (submitted October 31, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 22, 2021 None (earliest Version on record)
2 October 31, 2022 Study Status
Comparison Format:

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Study NCT05094141
Submitted Date:  October 22, 2021 (v1)

Open or close this module Study Identification
Unique Protocol ID: STU-2020-0607
Brief Title: Comparing Virtual Reality (VR) to Non-VR for Decreasing Preoperative/Procedural Anxiety
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)
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2021
Overall Status: Recruiting
Study Start: January 13, 2021
Primary Completion: December 31, 2023 [Anticipated]
Study Completion: December 31, 2023 [Anticipated]
First Submitted: October 22, 2021
First Submitted that
Met QC Criteria:
October 22, 2021
First Posted: October 26, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
October 22, 2021
Last Update Posted: October 26, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: University of Texas Southwestern Medical Center
Responsible Party: Principal Investigator
Investigator: Sarah E Rebstock
Official Title: Associate Professor
Affiliation: University of Texas Southwestern Medical Center
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module 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.

Detailed Description:
Open or close this module Conditions
Conditions: Preoperative Anxiety
Keywords: virtual reality
preoperative anxiety
modified Yale Preoperative Anxiety Scale
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Crossover Assignment
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)
Number of Arms: 2
Masking: Single (Participant)
Allocation: Randomized
Enrollment: 77 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Virtual reality
Virtual reality game
Open or close this module Outcome Measures
Primary Outcome Measures:
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.

2. 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 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.
Open or close this module Eligibility
Minimum Age: 5 Years
Maximum Age: 12 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

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
Open or close this module Contacts/Locations
Central Contact Person: Christina Howard
Telephone: 214-456-8559
Email: Christina.Howard@utsouthwestern.edu
Study Officials: Sarah Rebstock, MD
Principal Investigator
UT Southwestern
Neethu Chandran
Principal Investigator
UT Southwestern
Locations: United States, Texas
UT Southwestern
[Recruiting]
Dallas, Texas, United States, 75390
Contact:Contact: Christina Howard 214-456-8559
Open or close this module IPDSharing
Plan to Share IPD: No
General information
Open or close this module References
Citations:
Links:
Available IPD/Information:

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