Virtual Reality as a Perioperative Teaching Tool for Families

Surgical Procedure, Unspecified Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05008107
• Other study ID #: STUDY00001402
• Status: Completed
• Phase: N/A
• Start date: October 22, 2021
• Est. completion date: July 27, 2023

Study information

• Verified date: February 2024
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: July 27, 2023
• Est. primary completion date: July 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertrophy
• Surgical Procedure, Unspecified
• Tonsil Hypertrophy

Intervention

Other:
• Virtual reality
Using VR goggles to watch peri-operative instructional video.

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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