AR Health Education Video for Postoperative Breast Cancer Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorTungs' Taichung Metroharbour Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Augmented Reality Health Education Video
BehavioralAn 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
BehavioralRoutine perioperative health education provided according to standard clinical nursing care procedures.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: AR Health Education GroupExperimental treatment 1 intervention
Group B: Routine Health Education GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
State Anxiety
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.
Time frame
Baseline, postoperative day 1, and postoperative day 2Secondary outcomes
1
Depression
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.
Time frame
Baseline, postoperative day 1, and postoperative day 22
Physiological Indicators
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.
Time frame
Baseline, postoperative day 1, and postoperative day 2Sponsors and contacts
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Source ClinicalTrials.gov