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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04141943
• Other study ID #: 4-2019-0795
• Status: Recruiting
• Phase: N/A
• Start date: March 13, 2020
• Est. completion date: October 2021

Study information

• Verified date: November 2020
• Source: Yonsei University
• Contact: Yong Bae Kim
• Phone: +82-2228-8095
• Email: ybkim3[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 196
• Est. completion date: October 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul	Korea

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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