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| ID | Type | Description | Link |
|---|---|---|---|
| 113090 | Other Identifier | Institutional Review Board of Tungs' Taichung MetroHarbor Hospital | |
| TTMHH-R1140011 | Other Identifier | Research Department, Tungs' Taichung MetroHarbor Hospital |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AR Health Education Group | Experimental | Participants receive routine perioperative health education in addition to augmented reality (AR) health education videos related to breast cancer surgery and postoperative care. |
|
| Routine Health Education Group | Active Comparator | Routine perioperative health education provided according to standard clinical nursing care procedures. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, postoperative day 1, and postoperative day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tungs' Taichung MetroHarbor Hospital | Recruiting | Taichung | Taichung City | 435 | Taiwan |
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.
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Participants are randomly assigned to either an intervention group receiving routine health education plus augmented reality (AR) health education videos or a control group receiving routine health education alone.
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The outcome assessor responsible for collecting the preoperative and postoperative questionnaires is blinded to group allocation.
| Routine Health Education | Behavioral | Routine perioperative health education provided according to standard clinical nursing care procedures. |
|
| Baseline, postoperative day 1, and postoperative day 2 |
| 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. | Baseline, postoperative day 1, and postoperative day 2 |
| D017437 |
| Skin and Connective Tissue Diseases |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |