Virtual Reality as a Perioperative Teaching Tool for Families

Virtual Reality as a Perioperative Teaching Tool for Families: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Surgical Procedure, Unspecified; Tonsil Hypertrophy
• Intervention / Treatment: Other: Virtual reality

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline
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.	Baseline
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.	Immediately prior to discharge
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.	Immediately prior to discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Immediately prior to discharge

Collaborators and Investigators

• Sponsor: Nationwide Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2021
• Primary Completion (Actual): July 27, 2023
• Study Completion (Actual): July 27, 2023

Study Registration Dates

• First Submitted: July 26, 2021
• First Submitted That Met QC Criteria: August 13, 2021
• First Posted (Actual): August 17, 2021

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hypertrophy
• Other Study ID Numbers: STUDY00001402

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No