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

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ClinicalTrials.gov Identifier: NCT05094141
Recruitment Status : Recruiting
First Posted : October 26, 2021
Last Update Posted : October 26, 2021
Sponsor:
Information provided by (Responsible Party):
Sarah E Rebstock, University of Texas Southwestern Medical Center

Tracking Information
First Submitted Date  ICMJE October 22, 2021
First Posted Date  ICMJE October 26, 2021
Last Update Posted Date October 26, 2021
Actual Study Start Date  ICMJE January 13, 2021
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2021)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparing Virtual Reality (VR) to Non-VR for Decreasing Preoperative/Procedural Anxiety
Official Title  ICMJE 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)
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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)
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Preoperative Anxiety
Intervention  ICMJE Other: Virtual reality
Virtual reality game
Study Arms  ICMJE
  • 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
    Intervention: Other: Virtual reality
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 22, 2021)
77
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2023
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Christina Howard 214-456-8559 Christina.Howard@utsouthwestern.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05094141
Other Study ID Numbers  ICMJE STU-2020-0607
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: General information
Current Responsible Party Sarah E Rebstock, University of Texas Southwestern Medical Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Texas Southwestern Medical Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sarah Rebstock, MD UT Southwestern
Principal Investigator: Neethu Chandran UT Southwestern
PRS Account University of Texas Southwestern Medical Center
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP