Clinical trial NCT04141943: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: Breast cancer
radiotherapy
virtual reality
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2019-10-28
Enrollment: 196
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Amsterdam Preoperative Anxiety and Information Scale (APAIS)
timeFrame: Prior to receiving the radiotherapy information via VR or printed document
measure: Amsterdam Preoperative Anxiety and Information Scale (APAIS)
timeFrame: 5 minutes after receiving the radiotherapy information via VR or printed document
Secondary outcomes:
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: Prior to receiving the radiotherapy information via VR or printed document
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: 5 minutes after receiving the radiotherapy information via VR or printed document
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
state: Korea
Study officials:
References: