Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT06541587

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

Led by Hsin Yi Lu · Updated on 2024-08-07

60

Participants Needed

1

Research Sites

56 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age above 18 years.
  • Diagnosed with breast cancer stages I to III, including diagnostic codes C50, C79.81, C84.7A, D03.52, D05, D24, D48, or D49 with no restrictions on tumor type or receptor subtype.
  • Undergoing the first inpatient preoperative or postoperative chemotherapy, without restrictions on medication type or treatment cycles.
  • Able to communicate in Mandarin and literate.
  • No cognitive impairments, psychiatric disorders, motion sickness, epilepsy, or history of drug or alcohol addiction.
  • No prior experience with mindfulness-based interventions.
  • Understand research procedures, agree to participate, and sign informed consent.
  • Own a smartphone capable of installing required research applications and able to operate it independently.
Not Eligible

You will not qualify if you...

  • Blindness or visual impairments that prevent identification of on-screen visuals.
  • Auditory impairments that prevent recognition of sounds through headphones.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Tri-Service General Hospital

Taipei, Neihu Distinct, Taiwan, 114

Actively Recruiting

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Research Team

H

Hsin-Yi Lu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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