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Application and Effectiveness Evaluation of Digital Preoperative Consultation Model in Breast Surgery: A Prospective Randomized Controlled Clinical Trial

Application and Effectiveness Evaluation of Digital Preoperative Consultation Model in Breast Surgery: A Prospective Randomized Controlled Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600122989
Enrollment
Unknown
Registered
2026-04-20
Start date
2026-04-20
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast diseases requiring surgical intervention

Interventions

Experimental group:Watch standardized surgical plan educational videos
Control group:None

Sponsors

Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Disease diagnosis: Confirmed as a breast disease (including breast cancer or precancerous lesions, etc.), and clinically assessed as requiring surgical treatment; 2.Age and Informed Consent: 18-80 years old, with full legal capacity; 3.Surgical candidates: Individuals assessed by surgeons as suitable for mastectomy, lumpectomy, or endoscopic breast removal with implant, meaning they face a genuine choice of surgical options; 4.Communication and cognitive abilities: Clear consciousness, no serious visual or auditory impairments, able to communicate effectively in Chinese, and able to independently or with the assistance of researchers complete questionnaire surveys; 5.Voluntary participation: Voluntarily participate in this study and sign a written informed consent form.

Exclusion criteria

Exclusion criteria: 1.Emergency surgery patients: those who require emergency surgery due to their condition and are unable to undergo standard preoperative communication procedures; 2.Cognitive or psychiatric disorders: Individuals with known severe cognitive impairment (such as dementia) or a history of mental illness (such as schizophrenia, major depression, etc.) who, according to the researcher's assessment, may affect their understanding or decision-making ability regarding conversation content; 3.Previous surgical history: There is a history of previous surgeries on the same breast (such as breast augmentation, breast reduction, benign tumor resection, etc.), which may significantly affect the selection and decision-making process of the current surgical method; 4.Participating in other studies during the same period: Currently participating in other clinical researchers who may interfere with the outcome evaluation of this study; 5.Communication barriers: inability to read or understand Chinese, or other serious communication barriers that prevent the completion of the research evaluation; 6.Lack of personal freedom and independent civil capacity; 7.Researchers have determined that patients cannot obtain long-term follow-up data (due to unavailability or severe comorbidities).

Design outcomes

Primary

MeasureTime frame
Knowledge mastery level;Doctor's time efficiency;

Secondary

MeasureTime frame
State anxiety level;Patient satisfaction;Patient confidence level;

Countries

China

Contacts

Public ContactWang Jue

Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)

wangjue200011@163.com+86 180 6169 5508

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 1, 2026