Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06541587
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-01-05
Brief Title:
Smart VR Mindfulness for Breast Cancer Integrating Biofeedback and Evaluating Chemotherapy Effectiveness
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Smart Virtual Reality Mindfulness System for Breast Cancer Chemotherapy Integrating Stress Reduction Combined Multimodal Biofeedback and Clinical Effectiveness Evaluation
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Background Breast cancer patients undergoing chemotherapy commonly experience physical and emotional symptoms with approximately 90 percent of patients being affected Perceived stress is one of the related factors that can contribute to symptom severity Inadequate control of symptoms can have significant negative consequences on patients quality of life treatment adherence disease prognosis and increase the number of doctor visits and overall treatment outcomes The application of virtual reality in improving symptoms and perceived stress in breast cancer patients undergoing chemotherapy is an area of ongoing research and the findings from existing studies have been inconsistent Additionally the incorporation of mindfulness techniques within VR interventions for this specific population has been limited
Objective This study aims to explore the effectiveness of mindfulness-based virtual reality on the stress perception and symptom severity of breast cancer patients undergoing chemotherapy
Methods Stratified block randomization will be used to assign 20 patients each to the mindfulness based virtul reality group the mindfulness based audio practice group and the control group totaling 60 participants Data analysis will be conducted using the generalized estimating equation and machine learning
Expected results To understand the effectiveness of mindfulness-based virtual reality on the stress perception and the symptoms severity of chemotherapy in breast cancer patients in order to serve as a reference for improving the quality of care for cancer patients in the future
Objective This study aims to explore the effectiveness of mindfulness-based virtual reality on the stress perception and symptom severity of breast cancer patients undergoing chemotherapy
Methods Stratified block randomization will be used to assign 20 patients each to the mindfulness based virtul reality group the mindfulness based audio practice group and the control group totaling 60 participants Data analysis will be conducted using the generalized estimating equation and machine learning
Expected results To understand the effectiveness of mindfulness-based virtual reality on the stress perception and the symptoms severity of chemotherapy in breast cancer patients in order to serve as a reference for improving the quality of care for cancer patients in the future
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None