RecruitingNot ApplicableNCT06541587

Smart VR Mindfulness for Breast Cancer: Integrating Biofeedback and Evaluating Chemotherapy Effectiveness

Smart Virtual Reality Mindfulness System for Breast Cancer Chemotherapy: Integrating Stress Reduction Combined Multimodal Biofeedback and Clinical Effectiveness Evaluation


Sponsor

Hsin Yi Lu

Enrollment

60 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Breast cancer patients undergoing chemotherapy often face significant physical and emotional symptoms, with stress contributing to symptom severity. This study investigates the effectiveness of a mindfulness-based virtual reality (VR) intervention in reducing stress and symptom severity. A total of 60 participants will be stratified and randomized into three groups: mindfulness-based VR, mindfulness-based audio, and control. Data will be analyzed using generalized estimating equations and machine learning. The goal is to improve understanding and quality of care for cancer patients by evaluating the potential benefits of mindfulness-based VR interventions.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria5

  • Age above 18 years.
  • Diagnosed with breast cancer stages I to III, with diagnostic codes C50, C79.81, C84.7A, D03.52, D05, D24, D48, or D49; there are no restrictions on tumor type, receptor subtype, or whether breast tumor removal surgery has been performed.
  • Undergoing the first inpatient preoperative or postoperative chemotherapy, without restrictions on the type of medication or treatment cycles.
  • Able to communicate in Mandarin and literate; without cognitive impairments, psychiatric disorders, motion sickness, epilepsy, or a history of drug or alcohol addiction.
  • No prior experience with mindfulness-based interventions. Understanding of the research procedures, agreement to participate, and signing of the informed consent form; owning a smartphone capable of installing the required research applications and able to operate independently.

Exclusion Criteria2

  • individuals with blindness or visual impairments that preclude the identification of on-screen visuals
  • individuals with auditory impairments preventing the recognition of sounds through headphones.

Interventions

BEHAVIORALmindfulness based virtual reality

mindfulness based virtual reality

BEHAVIORALmindfulness based audio practice

mindfulness based audio practice


Locations(1)

Tri-Service General Hospital

Taipei, Neihu Distinct, Taiwan

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