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Virtual Reality as a Perioperative Teaching Tool for Families

Primary Purpose

Surgical Procedure, Unspecified, Tonsil Hypertrophy

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual reality
Sponsored by
Nationwide Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Surgical Procedure, Unspecified

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nationwide Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Virtual Reality

Control

Arm Description

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.

Families will receive standard pre-operative instructions.

Outcomes

Primary Outcome Measures

Patient Pre-op Anxiety Score
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.
Parent Pre-op Anxiety Score
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.
Patient Post-op Anxiety Score
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.
Parent Post-op Anxiety Score
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

Parent Satisfaction Score
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.

Full Information

First Posted
July 26, 2021
Last Updated
January 11, 2023
Sponsor
Nationwide Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05008107
Brief Title
Virtual Reality as a Perioperative Teaching Tool for Families
Official Title
Virtual Reality as a Perioperative Teaching Tool for Families: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 22, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nationwide Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Procedure, Unspecified, Tonsil Hypertrophy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Families will receive standard pre-operative instructions.
Intervention Type
Other
Intervention Name(s)
Virtual reality
Other Intervention Name(s)
VR
Intervention Description
Using VR goggles to watch peri-operative instructional video.
Primary Outcome Measure Information:
Title
Patient Pre-op Anxiety Score
Description
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.
Time Frame
Baseline
Title
Parent Pre-op Anxiety Score
Description
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.
Time Frame
Baseline
Title
Patient Post-op Anxiety Score
Description
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.
Time Frame
Immediately prior to discharge
Title
Parent Post-op Anxiety Score
Description
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.
Time Frame
Immediately prior to discharge
Secondary Outcome Measure Information:
Title
Parent Satisfaction Score
Description
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.
Time Frame
Immediately prior to discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States

12. IPD Sharing Statement

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Virtual Reality as a Perioperative Teaching Tool for Families

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