Breast CancerAR-BCSNCT07604389
AR Health Education Video for Postoperative Breast Cancer Patients
A study testing Augmented Reality Health Education Video and Routine Health Education in people with Breast Cancer and Anxiety, run by Tungs' Taichung Metroharbour Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Anxiety, Depression
- What is being tested?
- Augmented Reality Health Education Video and Routine Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Jun 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Tungs' Taichung MetroHarbor Hospital
Taichung, Taichung City, 435
Hsin-Hua Chen, RN, MSN, +886919090022, yugagn@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer, Anxiety, Depression
- Being tested
- Augmented Reality Health Education Video, Routine Health Education
- Keywords
- Augmented Reality, Breast Cancer Surgery, Perioperative Health Education, Nursing Education, Postoperative Anxiety, Postoperative Depression
- Medical subject headings
- Breast Neoplasms, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmented Reality Health Education VideoBehavioural
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 EducationBehavioural
Routine perioperative health education provided according to standard clinical nursing care procedures.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Augmented Reality Health Education Video |
| Routine Health Education Group | Active comparator | Routine perioperative health education provided according to standard clinical nursing care procedures. Receives: Behavioral: Routine Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, postoperative day 1, and postoperative day 2
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline, postoperative day 1, and postoperative day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start17 Jun 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tungs' Taichung Metroharbour Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07604389
- Sponsor's protocol ID
- TTMHH-R1140011
- Other IDs
- 113090, TTMHH-R1140011
- Acronym
- AR-BCS
- Status last verified
- May 2026
- First submitted
- 17 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of AR Health Education Video Intervention on Anxiety and Depression in Postoperative Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT07604389
- Acronym / sponsor ID
- AR-BCS / TTMHH-R1140011
- Conditions
- Breast Cancer, Anxiety, Depression
- Keywords
- Augmented Reality, Breast Cancer Surgery, Perioperative Health Education, Nursing Education, Postoperative Anxiety, Postoperative Depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tungs' Taichung Metroharbour HospitalUniversity, hospital or other
- Study start
- 17 Jun 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| AR Health Education Group | Experimental | Behavioral: Augmented Reality Health Education VideoParticipants 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 | Behavioral: Routine Health EducationRoutine perioperative health education provided according to standard clinical nursing care procedures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Augmented Reality Health Education VideoAn 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. | Behavioural | AR Health Education Group |
| Routine Health EducationRoutine perioperative health education provided according to standard clinical nursing care procedures. | Behavioural | Routine Health Education Group |
Primary outcome
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.
2 secondary outcomes
Depression
Time frame: Baseline, postoperative day 1, and postoperative day 2
Physiological Indicators
Time frame: Baseline, postoperative day 1, and postoperative day 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: Undecided. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Augmented Reality Health Education Video and Routine Health Education in people with Breast Cancer and Anxiety, run by Tungs' Taichung Metroharbour Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State Anxiety (time frame: Baseline, postoperative day 1, and postoperative day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.