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

Sponsor

Yonsei University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04141943

Collaborator

(none)

196

Enrollment

Location

Arms

18.6

Anticipated Duration (Months)

10.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Other: Virtual reality	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

196 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Mar 13, 2020

Anticipated Primary Completion Date :

Oct 1, 2021

Anticipated Study Completion Date :

Oct 1, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Amsterdam Preoperative Anxiety and Information Scale (APAIS) [Prior to receiving the radiotherapy information via VR or printed document]
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)
Amsterdam Preoperative Anxiety and Information Scale (APAIS) [5 minutes after receiving the radiotherapy information via VR or printed document]
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)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 64 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Severance Hospital	Seoul	Korea	Korea, Republic of	120-752

Sponsors and Collaborators

Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yonsei University

ClinicalTrials.gov Identifier:

NCT04141943

Other Study ID Numbers:

4-2019-0795

First Posted:

Oct 28, 2019

Last Update Posted:

Nov 18, 2020

Last Verified:

Nov 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Yonsei University

Breast cancer

radiotherapy

virtual reality

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of Nov 18, 2020