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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Taiwan
Tri-Service General Hospital
RECRUITING
Taipei
Contact Information
Primary
Hsin-Yi Lu
f8888877@gmail.com
+886972221359
Time Frame
Start Date: 2024-03-01
Estimated Completion Date: 2025-03-30
Participants
Target number of participants: 60
Treatments
Experimental: mindfulness-based virtual reality
In addition to routine chemotherapy care, the intervention involves the use of a smart breast cancer chemotherapy mindfulness-based integrated virtual reality and multimodal physiological feedback training system module. This will be administered during each of the first to fifth inpatient chemotherapy sessions. The equipment operator, a researcher, will use the AI-Pico Neo 3 Pro headset, featuring a dual-eye resolution of 2880\*1600 pixels, a refresh rate of 90Hz, and a 110-degree field of view. The interpupillary distance, headset strap tightness, and volume will be adjusted according to the participant's comfort. The scenario content includes three shared scenes: beach, forest, and starry sky, from which participants can choose based on their preference. Each session will last 12 minutes and be conducted once. Participants will assume a semi-reclining position during the session. Monitoring will be conducted with the researcher assisting the participant on-site.
Active_comparator: mindfulness based audio practice
In addition to routine chemotherapy care, the intervention includes mindfulness-based audio exercises. Participants will use over-ear headphones that play the same content as experimental group A, but without virtual reality. This will be administered during each of the first to fifth inpatient chemotherapy sessions. The equipment operator, a researcher, will use Sony over-ear headphones, adjusting the fit and volume according to the participant's comfort. The audio content includes three background sounds: beach, forest, and starry sky, from which participants can choose based on their preference. Each session will last 12 minutes and be conducted once. Participants will assume a semi-reclining position during the session. Monitoring will be conducted with the researcher assisting the participant on-site.
No_intervention: control
routine chemotherapy care
Related Therapeutic Areas
Sponsors
Leads: Hsin Yi Lu

This content was sourced from clinicaltrials.gov