NCT07604389

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
8mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress60%
Jun 2025Dec 2026

Study Start

First participant enrolled

June 17, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 22, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

1.5 years

First QC Date

May 17, 2026

Last Update Submit

May 17, 2026

Conditions

Keywords

Augmented RealityBreast Cancer SurgeryPerioperative Health EducationNursing EducationPostoperative AnxietyPostoperative Depression

Outcome Measures

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.

    Baseline, postoperative day 1, and postoperative day 2

Secondary Outcomes (2)

  • Depression

    Baseline, postoperative day 1, and postoperative day 2

  • Physiological Indicators

    Baseline, postoperative day 1, and postoperative day 2

Study Arms (2)

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.

Behavioral: Augmented Reality Health Education Video

Routine Health Education Group

ACTIVE COMPARATOR

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

Behavioral: Routine Health Education

Interventions

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.

AR Health Education Group

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

Routine Health Education Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tungs' Taichung MetroHarbor Hospital

Taichung, Taichung City, 435, Taiwan

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesMental DisordersBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome assessor responsible for collecting the preoperative and postoperative questionnaires is blinded to group allocation.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2026

First Posted

May 22, 2026

Study Start

June 17, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

May 22, 2026

Record last verified: 2026-05

Locations