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Clinical study on the combination of Augmented Reality (AR) technology and Five-Element Music Therapy for Improving Anxiety Symptoms in Patients undergoing Minimally invasive Breast Surgery: A single-center, randomized controlled, single-blind, open-label clinical trial

Construction and Application Study of a Virtual Reality-Based Preoperative and Intraoperative Health Education System for Breast Surgery under Local Anesthesia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500115166
Enrollment
Unknown
Registered
2025-12-23
Start date
2026-02-01
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Breast mass

Interventions

Control group:The control group received conventional preoperative health education. During preoperative ward rounds, patients were educated about their disease and surgical-related information, infor
Trial Group A:Received AR education + intraoperative AR relaxation video combined with five elements music therapy
Trial Group B:Received AR education and intraoperative AR relaxation video combined with western traditional music

Sponsors

Guangzhou Women and Children Medical Center, Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria of benign breast tumor, breast fibrocystic hyperplasia, breast adenosis, breast fibrocystic breast disease; 2. Women aged 18-70 years old (including 18 and 70 years old); 3. Patients with indications for vac uum-assisted breast biopsy (VABB); 4. Preoperative Hospital Anxiety and Depression Scale (HADS) showed that the patient had anxiety and depression, that is, SAS score =7 points; 5. Patients who volunteered to participate in the trial with the consent of their family members and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant (preparing for pregnancy) or lactating women; 2. Concomitant diseases requiring sex hormone therapy, such as dysfunctional uterine bleeding, amenorrhea, polycystic ovary syndrome, menopausal syndrome, hyperprolactinemia, etc. 3. Patients with malignant tumors; 4.Patients with breast inflammatory disease; 5. Those who are allergic to the ingredients of the trial drugs; 6. Serious primary diseases of the heart, brain, lung, kidney, liver and hematopoietic system; 7. Patients with mental illness or intellectual disability, hearing or cognitive impairment; 8. Patients who have received or are prepared to receive other forms of treatment for anxiety.

Design outcomes

Primary

MeasureTime frame
Heart rate variability, blood pressure;Hospital Anxiety and Depression Scale (HADS) score;Preoperative knowledge awareness level;

Secondary

MeasureTime frame
Intraoperative pain VAS scale;Intraoperative cooperation;

Countries

China

Contacts

Public ContactWu Xiaozhen

Guangzhou Women and Children's Medical Center

287840600@qq.com+86 137 6079 3982

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026