The Effect of Meditation on Reducing Chemotherapy-Induced Nausea and Vomiting in Women With Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Nausea Severity
研究概览
简要总结
This randomized clinical trial aimed to evaluate the effectiveness of Twin Hearts Meditation in reducing chemotherapy-induced nausea and vomiting among women with breast cancer undergoing chemotherapy. Chemotherapy-related nausea and vomiting are among the most distressing side effects of cancer treatment and can negatively affect patients' quality of life, nutritional status, and adherence to therapy.
The study focused on whether regular practice of this meditation technique could significantly reduce the severity of nausea and the frequency of vomiting episodes following chemotherapy. The main research questions were:
Does Twin Hearts Meditation reduce chemotherapy-induced nausea and vomiting among women with breast cancer? Can this complementary and non-invasive intervention be considered a supportive strategy for managing chemotherapy-related symptoms?
Participants were randomly assigned to either the intervention group, which practiced Twin Hearts Meditation, or the control group, which received routine care without meditation. The intervention group received a 30-minute guided meditation training session and practiced the meditation three times per week for two weeks.
Nausea severity and vomiting episodes were assessed using a nausea severity scale and a vomiting record flow sheet at baseline and at 6, 12, 18, and 24 hours after chemotherapy to evaluate the effectiveness of the intervention.
详细描述
Study Title
The Effect of Twin Hearts Meditation on Chemotherapy-Induced Nausea and Vomiting in Women With Breast Cancer
Study Purpose
The aim of this study was to investigate the effectiveness of Twin Hearts Meditation, a mind-body relaxation technique used in complementary and alternative medicine, in reducing chemotherapy-induced nausea and vomiting among women with breast cancer. Chemotherapy-related nausea and vomiting remain common and distressing side effects despite the routine use of antiemetic medications. This study evaluates whether meditation can serve as a supportive non-pharmacological intervention to reduce symptom severity and improve patient comfort during chemotherapy treatment.
Sample Size Determination
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
- Double (Investigator, Outcomes Assessor)
盲法说明
To minimize bias, a single-blind approach was used. The researcher responsible for outcome assessment and data collection was unaware of group allocation. In addition, the statistician who performed the data analysis was blinded to group assignments. The data were analyzed using coded variables (X1 and X2) to maintain objectivity and prevent bias during statistical analysis.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 18-65 years diagnosed with non-metastatic breast cancer.
- •Patients undergoing chemotherapy using standard chemotherapy regimens in the oncology unit.
- •Patients who had experienced nausea during at least one previous chemotherapy session.
- •Patients who voluntarily agreed to participate in the study and provided written informed consent
排除标准
- •Performing meditation fewer than three times per week during the intervention period.
- •Unwillingness to continue participation in the study.
- •Presence of medical conditions that may independently cause nausea, such as severe gastrointestinal disease, renal failure, or hepatic disease.
研究组 & 干预措施
Twin Hearts Meditation
Behavioral: Twin Hearts Meditation
Participants in this group receive Twin Hearts Meditation, a structured mind-body relaxation technique designed to promote emotional balance and psychological well-being. The intervention aims to reduce chemotherapy-induced nausea and vomiting by promoting relaxation, stress reduction, and improved emotional regulation in women with breast cancer undergoing chemotherapy
干预措施: Twin Heart Meditation (Behavioral)
Routine Care
Participants in the control group received routine clinical care during chemotherapy and did not receive any additional behavioral intervention during the study period.
结局指标
主要结局
Nausea Severity
时间窗: Nausea severity is assessed at 6, 12, 18, and 24 hours after chemotherapy
The primary outcome measure evaluates changes in the severity of chemotherapy-induced nausea among women with breast cancer undergoing chemotherapy. Nausea severity is assessed using a Visual Self-Reporting Nausea Scale, scored from 0 to 10, where 0 indicates no nausea and 10 indicates the most severe nausea. Higher scores indicate greater nausea severity
次要结局
- Frequency of Vomiting Episodes(Vomiting frequency is assessed at 6, 12, 18, and 24 hours after chemotherapy)
研究者
Pouran Varvani Farahani
PhD in Pediatric Nursing, Department of Nursing, Faculty of Health Science, Cyprus International University,
Cyprus International University