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NCT Number: NCT07604389

AR Health Education Video for 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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tungs' Taichung MetroHarbor Hospital

Taichung, Taichung City, 435, Taiwan

Location status: Recruiting

Location contact

Hsin-Hua Chen, RN, MSN

CONTACT

[email protected]

+886919090022

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Augmented Reality Health Education Video

Behavioral

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.

routine health education

Behavioral

Routine perioperative health education provided according to standard clinical nursing care procedures.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  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.

Sponsors and collaborators

Lead sponsor

Tungs' Taichung Metroharbour Hospital

Other

Registry information

Official study title

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

Acronym: AR-BCS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 22, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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