Virtual Reality as a Perioperative Teaching Tool for Families

Sponsor
Nationwide Children's Hospital (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05008107
Collaborator
(none)
160
1
2
13.3
12

Study Details

Study Description

Brief Summary

Commonly, families and providers have turned to internet-based resources to provide insight as to the perioperative experience. Though there is a large amount of information that is available on the internet, medical information on the internet is of highly variable quality and the information may be conflicting or inaccurate. It is hard for even the savvy well-educated patient and family to navigate and sift through all the information available. Therefore, generic web-based information does not necessarily decrease patient and caregiver anxiety. As an alternative, the investigators propose an interactive teaching tool utilizing virtual reality that may provide a cost-efficient, content-rich supplement to the traditional phone or internet-based patient education. Virtual reality (VR) will be provided to families of patients undergoing ambulatory pediatric surgery. VR will provide personalized education to patients and their families about the entire continuum of the child's surgical experience. This will range from the hospital registration, the peri-operative experience, including the separation of the child from the parent in the pre-operative area and the anesthetic induction process, and the post-operative hospital ward. The virtual reality (VR) tool will also review the in-hospital post-operative recovery process. The patient will be shown this either via an oculus headset or using their own smartphone device. In addition to improving a parent's comprehension of what their child will experience, the investigators expect that the virtual reality tool may also improve patient and caregiver satisfaction with the overall perioperative experience.

Condition or Disease Intervention/Treatment Phase
  • Other: Virtual reality
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
160 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Virtual Reality as a Perioperative Teaching Tool for Families: A Randomized Controlled Trial
Actual Study Start Date :
Oct 22, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Virtual Reality

Virtual reality (VR) will be provided to families of patients undergoing ambulatory pediatric surgery. VR will provide personalized education to patients and their families about the entire continuum of the child's surgical experience. This will range from the hospital registration, the peri-operative experience, including the separation of the child from the parent in the pre-operative area and the anesthetic induction process, and the post-operative hospital ward.

Other: Virtual reality
Using VR goggles to watch peri-operative instructional video.
Other Names:
  • VR
  • No Intervention: Control

    Families will receive standard pre-operative instructions.

    Outcome Measures

    Primary Outcome Measures

    1. Patient Pre-op Anxiety Score [Baseline]

      The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety.

    2. Parent Pre-op Anxiety Score [Baseline]

      The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety.

    3. Patient Post-op Anxiety Score [Immediately prior to discharge]

      The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety.

    4. Parent Post-op Anxiety Score [Immediately prior to discharge]

      The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety.

    Secondary Outcome Measures

    1. Parent Satisfaction Score [Immediately prior to discharge]

      Assessed using an adaptation of the English version of the Leiden Perioperative Patient Satisfaction questionnaire (LPPSq). This questionnaire assesses 4 domains of satisfaction: information provision, professional competence, patient-staff relationship, and service with a total of 24 questions. Questions will be scored on a 1-5 Likert scale (from completely dissatisfied to completely satisfied) with the total satisfaction score ranging from 24-120 possible points.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Children undergoing tonsillectomy/adenotonsillectomy ± ear tubes in the ambulatory setting
    Exclusion Criteria:
    • Non-English speaking (VR program is currently only offered in English)

    • Inpatient

    • Unable to effectively use VR (blind, severe motion sickness)

    • History of procedure in the operating room within the past year

    • Having a combination/additional procedure

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nationwide Children's Hospital Columbus Ohio United States 43205

    Sponsors and Collaborators

    • Nationwide Children's Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Brittany Willer, Assistant Professor of Anesthesiology, Nationwide Children's Hospital
    ClinicalTrials.gov Identifier:
    NCT05008107
    Other Study ID Numbers:
    • STUDY00001402
    First Posted:
    Aug 17, 2021
    Last Update Posted:
    Dec 10, 2021
    Last Verified:
    Dec 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 10, 2021