CClinicalTrials.gg
Status unknownNCT04141943Updated Nov 18, 2020

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

An interventional study of Virtual reality in Breast Cancer, sponsored by Yonsei University. Status unknown at 1 site in Korea, Republic of. Open to female participants aged 20 Years to 64 Years. Per ClinicalTrials.gov, last updated 2020-11-18.

Sponsored by Yonsei University · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Nov 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
196
Allocation
Randomized
Ages
20 Years to 64 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Breast Cancer

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Keywords

  • Breast cancer
  • radiotherapy
  • virtual reality
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 196 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 64 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
196 participants (estimated)

Study arms

  • Experimental
    VR

    The patients who are allocated to the VR arm will receive information about radiotherapy via virtual reality

    Other: Virtual reality

  • No intervention
    Printed document

    The patients who are allocated to the Printed document arm will receive information about radiotherapy via printed document.

Interventions

  • OtherVirtual reality

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

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: Prior to receiving the radiotherapy information via VR or printed document

  2. 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)

    Time frame: 5 minutes after receiving the radiotherapy information via VR or printed document

Secondary outcomes

  1. State-Trait Anxiety Inventory (STAI)

    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

  2. State-Trait Anxiety Inventory (STAI)

    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

07

Study locations

1 of 1 sites recruiting
  • Severance Hospital
    Seoul, Korea 120-752, Korea, Republic of
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04141943
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Oct 28, 2019
Start date
Mar 13, 2020
Primary completion
Oct 2021 (estimated)
Completion
Oct 2021 (estimated)
Last update
Nov 18, 2020

Study contacts

Yong Bae Kim
Contact
ybkim3@yuhs.ac
+82-2228-8095

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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