Back to resultsImprovement of Patient Experience and Healthcare Providers' Productivity Using Virtual Reality in the Field of Radiation Therapy
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Virtual reality
Sponsored by
About this trial
This is an interventional other trial for Breast Cancer focused on measuring Breast cancer, radiotherapy, virtual reality
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
Sites / Locations
- Severance HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
VR
Printed document
Arm Description
The patients who are allocated to the VR arm will receive information about radiotherapy via virtual reality
The patients who are allocated to the Printed document arm will receive information about radiotherapy via printed document.
Outcomes
Primary Outcome Measures
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)
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)
Secondary Outcome Measures
State-Trait Anxiety Inventory (STAI)
Changes in STAI Before and After Providing Virtual Reality or Printed Document Information
State-Trait Anxiety Inventory (STAI)
Changes in STAI Before and After Providing Virtual Reality or Printed Document Information
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04141943
Brief Title
Improvement of Patient Experience and Healthcare Providers' Productivity Using Virtual Reality in the Field of Radiation Therapy
Official Title
Improvement of Patient Experience and Healthcare Providers' Productivity Using Virtual Reality in the Field of Radiation Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 13, 2020 (Actual)
Primary Completion Date
October 2021 (Anticipated)
Study Completion Date
October 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast cancer, radiotherapy, virtual reality
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
196 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
VR
Arm Type
Experimental
Arm Description
The patients who are allocated to the VR arm will receive information about radiotherapy via virtual reality
Arm Title
Printed document
Arm Type
No Intervention
Arm Description
The patients who are allocated to the Printed document arm will receive information about radiotherapy via printed document.
Intervention Type
Other
Intervention Name(s)
Virtual reality
Intervention Description
The patients who are allocated to the VR arm will receive information about radiotherapy via virtual reality.
Primary Outcome Measure Information:
Title
Amsterdam Preoperative Anxiety and Information Scale (APAIS)
Description
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)
Time Frame
Prior to receiving the radiotherapy information via VR or printed document
Title
Amsterdam Preoperative Anxiety and Information Scale (APAIS)
Description
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)
Time Frame
5 minutes after receiving the radiotherapy information via VR or printed document
Secondary Outcome Measure Information:
Title
State-Trait Anxiety Inventory (STAI)
Description
Changes in STAI Before and After Providing Virtual Reality or Printed Document Information
Time Frame
Prior to receiving the radiotherapy information via VR or printed document
Title
State-Trait Anxiety Inventory (STAI)
Description
Changes in STAI Before and After Providing Virtual Reality or Printed Document Information
Time Frame
5 minutes after receiving the radiotherapy information via VR or printed document
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yong Bae Kim
Phone
+82-2228-8095
Email
ybkim3@yuhs.ac
Facility Information:
Facility Name
Severance Hospital
City
Seoul
State/Province
Korea
ZIP/Postal Code
120-752
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
YongBae Kim, MD
Phone
82-10-6256-2592
Email
ybkim3@yuhs.ac
12. IPD Sharing Statement
Plan to Share IPD
No
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Improvement of Patient Experience and Healthcare Providers' Productivity Using Virtual Reality in the Field of Radiation Therapy
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