AR Health Education Video for Postoperative Breast Cancer Patients (AR-BCS)

May 17, 2026 updated by: Tungs' Taichung Metroharbour Hospital

Effects of AR Health Education Video Intervention on Anxiety and Depression in Postoperative Breast Cancer Patients

Breast cancer surgery patients may experience anxiety and depression before and after surgery. Health education can help patients understand the surgical process and postoperative care, but traditional education may not always be easy to understand.

This study evaluates whether augmented reality (AR) health education videos can help reduce anxiety and depression in postoperative breast cancer patients. Participants are randomly assigned to one of two groups. One group receives routine health education plus AR health education videos, and the other group receives routine health education only.

The study compares changes in anxiety, depression, and selected physiological indicators between the two groups before and after surgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a randomized controlled study. Eligible breast cancer surgery patients are randomly assigned to an AR health education group or a routine health education group.

Participants in the AR health education group receive routine perioperative health education plus AR health education videos. Participants in the routine health education group receive routine perioperative health education only.

An outcome assessor who is blinded to group allocation collects questionnaire data before surgery, on postoperative day 1, and on postoperative day 2. Anxiety is measured using the State-Trait Anxiety Inventory-State Anxiety Scale (STAI-S), and depression is measured using the Beck Depression Inventory-II (BDI-II). Physiological indicators, including heart rate, respiratory rate, blood pressure, and oxygen saturation, are also collected.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Taichung City
      • Taichung, Taichung City, Taiwan, 435
        • Recruiting
        • Tungs' Taichung MetroHarbor Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female patients aged 18 years or older with breast cancer.
  • Breast cancer confirmed by pathological examination.
  • Conscious and able to communicate in Mandarin or Taiwanese.
  • No visual or hearing impairment.
  • Willing to participate in this study and provide informed consent.

Exclusion Criteria:

  • Patients with brain metastasis, dementia, or cognitive impairment.
  • Patients currently taking antidepressants, anxiolytics, or other psychiatric medications.
  • Patients diagnosed with psychiatric disorders.
  • Patients with a history of hypertension.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AR Health Education Group
Participants receive routine perioperative health education in addition to augmented reality (AR) health education videos related to breast cancer surgery and postoperative care.
Behavioral: Augmented Reality Health Education Video
An augmented reality (AR)-based health education video designed to provide perioperative education, postoperative recovery guidance, daily activity adjustment, and self-care information for breast cancer surgery patients.
Active Comparator: Routine Health Education Group
Routine perioperative health education provided according to standard clinical nursing care procedures.
Behavioral: Routine Health Education
Routine perioperative health education provided according to standard clinical nursing care procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
State Anxiety
Time Frame: Baseline, postoperative day 1, and postoperative day 2
State anxiety is measured using the Chinese version of the State-Trait Anxiety Inventory-State Anxiety Scale (STAI-S). The STAI-S includes 20 items rated on a 4-point Likert scale, with total scores ranging from 20 to 80. Higher scores indicate higher levels of state anxiety. Scores of 20 to 39 indicate mild anxiety, 40 to 59 indicate moderate anxiety, and 60 to 80 indicate severe anxiety.
Baseline, postoperative day 1, and postoperative day 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression
Time Frame: Baseline, postoperative day 1, and postoperative day 2
Depression is measured using the Chinese version of the Beck Depression Inventory-II (BDI-II). The BDI-II includes 21 items rated from 0 to 3, with total scores ranging from 0 to 63. Higher scores indicate more severe depressive symptoms. Scores of 0 to 16 indicate normal range, 17 to 22 indicate mild depression, 23 to 30 indicate moderate depression, and 31 to 63 indicate severe depression.
Baseline, postoperative day 1, and postoperative day 2
Physiological Indicators
Time Frame: Baseline, postoperative day 1, and postoperative day 2
Physiological indicators include heart rate, respiratory rate, systolic blood pressure, diastolic blood pressure, and peripheral oxygen saturation. These indicators are collected to assess physiological responses related to anxiety during the perioperative period.
Baseline, postoperative day 1, and postoperative day 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tungs' Taichung Metroharbour Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

May 17, 2026

First Submitted That Met QC Criteria

May 17, 2026

First Posted (Actual)

May 22, 2026

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 17, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TTMHH-R1140011 (Other Identifier: Research Department, Tungs' Taichung MetroHarbor Hospital)
  • 113090 (Other Identifier: Institutional Review Board of Tungs' Taichung MetroHarbor Hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Individual participant data (IPD) sharing has not yet been determined. Data may be shared upon reasonable request and after approval by the corresponding author and institutional review board.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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