Effect of Foot Reflexology On Chemotherapy Induced Nausea and Vomiting in Breast Cancer Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Severity of Chemotherapy-Induced Nausea and Vomiting
研究概览
简要总结
This study aims to evaluate the effect of foot reflexology on chemotherapy-induced nausea and vomiting in breast cancer patients. Nausea and vomiting are common side effects of chemotherapy and can negatively affect patients' comfort and quality of life. Foot reflexology is a non-invasive complementary therapy that involves applying pressure to specific points on the feet. The study will compare patients who receive foot reflexology along with standard care to those who receive standard care alone, to determine whether foot reflexology helps reduce the severity of nausea and vomiting during chemotherapy.
详细描述
This study will be conducted to assess the effectiveness of foot reflexology in reducing chemotherapy-induced nausea and vomiting among breast cancer patients receiving chemotherapy. Eligible participants will be adult breast cancer patients undergoing scheduled chemotherapy treatment.
After enrollment, participants will be randomly assigned into two groups: an experimental group and a control group. The experimental group will receive foot reflexology in addition to standard chemotherapy care, while the control group will receive standard care only.
Foot reflexology will be administered by the researcher using a standardized technique. Each session will last approximately 20-30 minutes and will be provided during chemotherapy sessions across multiple chemotherapy cycles with an interval of 21 days. Reflex points associated with nausea, vomiting, relaxation, and digestion will be stimulated using appropriate pressure techniques.
Nausea and vomiting will be assessed using a standardized assessment tool before and after the intervention during each chemotherapy cycle. The collected data will be analyzed to compare the severity of nausea and vomiting between the experimental and control groups to determine the effectiveness of foot reflexology as a supportive therapy for managing chemotherapy-induced nausea and vomiting.
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
- None
盲法说明
This is an open-label study as blinding of participants and the researcher is not feasible due to the nature of the intervention.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Breast Cancer patients aged >18 Patients receiving chemotherapy in curative setting
排除标准
- •Patients with paraplegia. Patients with skin ulcers or wounds. Patients with psychiatric conditions. Patients with foot fractures and varicose veins. Patients with GIT and Liver Cancer
研究组 & 干预措施
Foot Reflexology plus Standard Care
Participants in this arm will receive foot reflexology in addition to standard chemotherapy care. Foot reflexology will be administered by the researcher using a standardized technique during chemotherapy sessions. Each session will last approximately 20-30 minutes and will be provided during each chemotherapy cycle with a 21-day interval. Standard care will be provided as per hospital protocol.
干预措施: Foot Reflexology (Other)
Standard Care
Participants in this arm will receive standard chemotherapy care as per hospital protocol. No foot reflexology intervention will be provided.
结局指标
主要结局
Severity of Chemotherapy-Induced Nausea and Vomiting
时间窗: From baseline to end of each chemotherapy cycle (up to four cycles, 21 days apart)
The severity of chemotherapy-induced nausea and vomiting will be assessed using the Rhodes Index of Nausea, Vomiting and Retching (RINVR), a validated scale measuring the frequency, severity, and distress of nausea and vomiting. Scores range from low to high, with higher scores indicating more severe symptoms. Measurements will be recorded before and after the intervention during each chemotherapy cycle.
Severity of Chemotherapy-Induced Nausea and Vomiting
时间窗: From baseline to end of each chemotherapy cycle (up to four cycles, 21 days apart)
The severity of chemotherapy-induced nausea and vomiting will be assessed using the Rhodes Index of Nausea, Vomiting and Retching (RINVR), a validated scale measuring the frequency, severity, and distress of nausea and vomiting. Scores range from low to high, with higher scores indicating more severe symptoms. Measurements will be recorded before and after the intervention during each chemotherapy cycle.
次要结局
未报告次要终点
研究者
Dania Azher Khan
MSN Student
University of Health Sciences Lahore