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Multi-dimensional Analysis of Insomnia in Breast Cancer Patients and the Effectiveness of Virtual Reality Biofeedback-Assisted Mindfulness-Based Stress Reduction Therapy

Multi-dimensional Analysis of Insomnia in Breast Cancer Patients and the Effectiveness of Virtual Reality Biofeedback-Assisted Mindfulness-Based Stress Reduction Therapy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500095716
Enrollment
Unknown
Registered
2025-01-10
Start date
2025-01-10
Completion date
Unknown
Last updated
2025-01-13

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

Conditions

Breast cancer

Interventions

Routine Intervention Group:Rehabilitation nursing was carried out according to the routine nursing methods of breast cancer patients, and oral sleep hygiene education was given to patients.
MBSR group:Mindfulness-based stress reduction training is based on Kabat-Zinn's original 8-week mindfulness-based stress reduction theory and is adapted to the patients own situation. Specific topics
VR-BF+MBSR group:Use a mindfulness-based stress reduction intervention assisted by VR biofeedback on top of the usual intervention. 1 time a day for 30 minutes for 4 weeks.

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Female patients aged >=18 years, histologically diagnosed with breast cancer according to the diagnostic criteria outlined in the "Chinese Anti-Cancer Association Guidelines and Specifications for the Diagnosis and Treatment of Breast Cancer (2024 Edition)"; 2. Patients with no prior history of insomnia who were diagnosed with insomnia after breast cancer confirmation, in accordance with the "International Classification of Sleep Disorders, Third Edition (ICSD-3)" and the "Chinese Guidelines for the Diagnosis and Treatment of Insomnia", with a Pittsburgh Sleep Quality Index (PSQI) score >7; 3.Patients and their families have provided informed consent for this study.

Exclusion criteria

Exclusion criteria: 1.Presence of mental or cognitive impairments; 2.Coexistence of other malignant tumors or significant functional organic diseases; 3. Regular use of psychotropic medications other than hypnotics; 4. Currently participating in or having participated in similar studies.

Design outcomes

Primary

MeasureTime frame
Pittsburgh Sleep Quality Index;

Secondary

MeasureTime frame
NRS?BFI-C?PHQ-9?GAD-7?SSS-CN?FACT-B(V4.0);HRV?TST?N3?N1+N2?REM?Wake;

Countries

China

Contacts

Public ContactJia Jie

Huashan Hospital, Fudan University

shannonjj@126.com+86 21 52887820

Outcome results

None listed

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