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

Study Overview
=================
Brief Summary
-----------------
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.

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.

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

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Other: Virtual reality


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Breast cancer patients who received curative surgery and are planned to receive radiotherapy Patients with cognitive abilities to receive virtual reality information Patients who are 20 years old or older Exclusion Criteria: Patients who have vision or hearing problems to receive information Patients who do not agree to this study Pregnancy, Fetuses / Newborns, Minors, and Deficient Patients 65 years old or older Patients who have been treated for dizziness within the last 6 months Patients who have experienced severe dizziness within the last 6 months when using electronic devices

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VR<br>The patients who are allocated to the VR arm will receive information about radiotherapy via virtual reality | Other: Virtual reality<br>* The patients who are allocated to the VR arm will receive information about radiotherapy via virtual reality.<br>|
| No Intervention: Printed document<br>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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast cancer, radiotherapy, virtual reality