Improvement of Patient Experience and Healthcare Providers' Productivity Using Virtual Reality in the Field of Radiation Therapy

The purpose of this study is to investigate the effect of providing information about radiotherapy using virtual reality and to see whether it would improve the productivity of medical staff, improve patient experience and satisfaction, and reduce patient's anxiety prior to radiotherapy.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Virtual reality

Detailed Description

All patients enrolled in this study will receive the same routine explanation all radiotherapy patients receive currently. However, prior to the routine explanation, additional detailed information regarding radiotherapy (from simulation to treatment) will be given in two different ways.

VR arm: The patients who are allocated to the VR arm will receive information about radiotherapy via virtual reality.

Printed document arm: The patients who are allocated to the Printed document arm will receive information about radiotherapy via printed document.

Patients will answer the questionnaire related to the anxiety scale related to radiotherapy and measure the vital signs such as blood pressure, pulse rate, and the respiratory rate. Also, patients will answer the questions about radiotherapy to assess the understanding of radiotherapy and questionnaire on hospital satisfaction.

• Study Type: Interventional
• Enrollment (Anticipated): 196
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Korea
    • Seoul, Korea, Korea, Republic of, 120-752
      • Recruiting
      • Severance Hospital
      • Contact: YongBae Kim, MD; Phone Number: 82-10-6256-2592; Email: ybkim3@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Breast cancer patients who received curative surgery and are planned to receive radiotherapy
2. Patients with cognitive abilities to receive virtual reality information
3. Patients who are 20 years old or older

Exclusion Criteria:

1. Patients who have vision or hearing problems to receive information
2. Patients who do not agree to this study
3. Pregnancy, Fetuses / Newborns, Minors, and Deficient Patients
4. 65 years old or older
5. Patients who have been treated for dizziness within the last 6 months
6. Patients who have experienced severe dizziness within the last 6 months when using electronic devices

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: VR; The patients who are allocated to the VR arm will receive information about radiotherapy via virtual reality	Other: Virtual reality; The patients who are allocated to the VR arm will receive information about radiotherapy via virtual reality.
No Intervention: Printed document; The patients who are allocated to the Printed document arm will receive information about radiotherapy via printed document.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amsterdam Preoperative Anxiety and Information Scale (APAIS)	Changes in APAIS Before and After Providing Virtual Reality or Printed Document Information - APAIS: scale from 1 (not worried at all) to 5 (extremely worried, most anxious)	Prior to receiving the radiotherapy information via VR or printed document
Amsterdam Preoperative Anxiety and Information Scale (APAIS)	Changes in APAIS Before and After Providing Virtual Reality or Printed Document Information - APAIS: scale from 1 (not worried at all) to 5 (extremely worried, most anxious)	5 minutes after receiving the radiotherapy information via VR or printed document

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
State-Trait Anxiety Inventory (STAI)	Changes in STAI Before and After Providing Virtual Reality or Printed Document Information	Prior to receiving the radiotherapy information via VR or printed document
State-Trait Anxiety Inventory (STAI)	Changes in STAI Before and After Providing Virtual Reality or Printed Document Information	5 minutes after receiving the radiotherapy information via VR or printed document

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2020
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): October 1, 2021

Study Registration Dates

• First Submitted: October 21, 2019
• First Submitted That Met QC Criteria: October 24, 2019
• First Posted (Actual): October 28, 2019

Study Record Updates

• Last Update Posted (Actual): November 18, 2020
• Last Update Submitted That Met QC Criteria: November 16, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: radiotherapy; Breast cancer; virtual reality
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 4-2019-0795

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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