The Effect of a Virtual Reality-Based Mindfulness Intervention on Anxiety, Comfort, Sleep, and Fatigue in Breast Cancer Patients Undergoing Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Fatigue Assessed Using the Cancer Fatigue Scale
研究概览
简要总结
Breast cancer is a public health issue with a high incidence among women worldwide, and its prevalence continues to increase each year. A breast cancer diagnosis brings significant physical, emotional, social, economic, and occupational changes. Chemotherapy, one of the most commonly used treatment modalities in cancer therapy, causes various physical and emotional symptoms while treating the disease. However, it is well known that these symptoms induced by chemotherapy can be prevented or alleviated through effective treatment and nursing interventions.
Recently, virtual reality (VR) and mindfulness-based interventions have been reported as effective tools and methods for managing the physical and psychological symptoms experienced by cancer patients.
The present study aims to evaluate the effect of a VR-integrated mindfulness-based intervention on anxiety, comfort, sleep, and fatigue levels among women newly diagnosed with breast cancer, both before and during chemotherapy treatment. The study is designed as a randomized controlled trial (RCT).
The study population will consist of individuals diagnosed with breast cancer at the Oncology Outpatient Clinic of Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital between May 2025 and December 2026. The study sample will include female breast cancer patients who are scheduled to receive adjuvant chemotherapy, meet the inclusion criteria, and volunteer to participate in the study.
According to the power analysis (with a 30% additional error margin), a total of 50 participants will be included - 25 in the intervention group and 25 in the control group.
The data will be collected using the following instruments: Patient Information Form, Beck Depression Inventory, Cancer Fatigue Scale, General Comfort Questionnaire-Short Form, State Anxiety Inventory, Jenkins Sleep Scale, and the Mindfulness-Based Self-Efficacy Scale.
It is expected that, as a result of this study, compared to the control group, participants in the intervention group who receive the VR-Mindfulness intervention during breast cancer treatment will demonstrate reduced levels of fatigue and anxiety and improved comfort and sleep quality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
This study is a randomized controlled trial with a parallel assignment model. Participants will be randomly assigned to either the intervention group, which will receive a virtual reality-based mindfulness intervention during chemotherapy, or the control group, which will receive routine care. Outcomes will be assessed at baseline, during the intervention period, and at follow-up.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Newly diagnosed with breast cancer, Female and aged 18 years or older, Diagnosed with stage II or III breast cancer, Scheduled to receive chemotherapy for breast cancer for the first time in the adjuvant or neoadjuvant setting, using either the CA regimen [C: cyclophosphamide; A: doxorubicin (Adriamycin)] or the TC regimen [T: docetaxel; C: cyclophosphamide], with or without paclitaxel, trastuzumab, docetaxel, or carboplatin, Scheduled to receive chemotherapy but have not yet started treatment, Have a Beck Depression Inventory (BDI) score of ≤30, have no physician-diagnosed psychiatric disorder according to the DSM-5 diagnostic criteria, and are not receiving treatment for a psychiatric disorder (Appendix 8), Have completed at least primary school education, Voluntarily agree to participate in the study.
排除标准
- •Presence of metastasis, History of seizures, Presence of vertigo, Presence of motion sickness with a tendency toward nausea and vomiting, Communication difficulties, including hearing, visual, or speech impairments, Unwillingness to participate in the study. Withdrawal Criteria
- •Participants will be withdrawn from the study if:
- •They discontinue the treatment protocol at any stage, Their treatment protocol is changed, They no longer wish to continue participating in the study.
结局指标
主要结局
Fatigue Assessed Using the Cancer Fatigue Scale
时间窗: Assessed three times: after chemotherapy education and before Cycle 1; after the third virtual reality mindfulness session during Cycle 2; and after the sixth session, 2-3 weeks after Cycle 4. Cycles occur every 14 or 21 days.
Fatigue will be assessed using the Cancer Fatigue Scale. The 15-item scale produces a total score ranging from 0 to 60. Higher scores indicate greater fatigue severity.
Comfort Assessed Using the General Comfort Questionnaire-Short Form
时间窗: Assessed three times: after chemotherapy education and before Cycle 1; after the third virtual reality mindfulness session during Cycle 2; and after the sixth session, 2-3 weeks after Cycle 4. Cycles occur every 14 or 21 days.
Comfort will be assessed using the General Comfort Questionnaire-Short Form. The 28-item scale produces a total score ranging from 28 to 168. Higher scores indicate a higher level of comfort.
Sleep Quality Assessed Using the Jenkins Sleep Scale
时间窗: Assessed three times: after chemotherapy education and before Cycle 1; after the third virtual reality mindfulness session during Cycle 2; and after the sixth session, 2-3 weeks after Cycle 4. Cycles occur every 14 or 21 days.
Sleep quality will be assessed using the Jenkins Sleep Scale. The four-item scale produces a total score ranging from 0 to 20. Higher scores indicate more frequent sleep problems and poorer sleep quality.
Anxiety Assessed Using the State-Trait Anxiety Inventory-State Anxiety Subscale
时间窗: Assessed three times: after chemotherapy education and before Cycle 1; after the third virtual reality mindfulness session during Cycle 2; and after the sixth session, 2-3 weeks after Cycle 4. Cycles occur every 14 or 21 days.
Anxiety will be assessed using the State Anxiety subscale of the State-Trait Anxiety Inventory. The 20-item subscale produces a total score ranging from 20 to 80. Higher scores indicate greater state anxiety.
Mindfulness-Based Self-Efficacy Assessed Using the Mindfulness-Based Self-Efficacy Scale-Revised
时间窗: Assessed three times: after chemotherapy education and before Cycle 1; after the third virtual reality mindfulness session during Cycle 2; and after the sixth session, 2-3 weeks after Cycle 4. Cycles occur every 14 or 21 days.
Mindfulness-based self-efficacy will be assessed using the 22-item Mindfulness-Based Self-Efficacy Scale-Revised. The mean score ranges from 0 to 4. Higher scores indicate greater mindfulness-based self-efficacy.
次要结局
未报告次要终点
研究者
Gizem Cansiz Ucar
Registered Nurse
Hacettepe University