Acupressure for Cancer Related Fatigue in Elderly Cancer Patients: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 主要终点
- Visual Analog Scale
研究概览
简要总结
The aim of this study was to investigate the effect of acupressure on the severity and level of cancer-related fatigue in elderly patients with cancer.
详细描述
Participants The research was carried out in two stages: quantitative and qualitative. The quantitative phase of the study was a randomized, controlled trial in pre-test post-test design. The second phase of the study was performed as a qualitative study by using individual in-depth interview method at the end of four weeks of acupressure.
The study was conducted with the volunteers from hematology and medical oncology clinic in a university hospital, in Turkey.
At the beginning of the study, a total of 20 patients, 10 for each acupressure and control groups, were included in order to calculate the sampling size of the study. As the result of the evaluation, a total of 28 patients (14 for acupressure, 14 for control groups) with 95% confidence level and 90% strength were included in the study. It was decided that 11 patients would be added to both group to reach the total of 50 patients (25 acupressure group, 25 control group) considering withdrawals from the study. Acupressure and control groups were randomized by computerized patient selection. The study was completed with a total of 31 patients (15 acupressure, 16 control group) who met the inclusion criteria At the end of the study, 95% confidence level was found as 99% for Visual Analog Scale (VAS) and 95% for total Piper Fatigue Scale (PFS) score in acupressure and control groups.
In order to carry out the study, the permission of the Ethics Committee of the Clinical Researches (decision no: 2013/670) and written permission was received from the clinics where the study will be conducted. The study was carried out in accordance with the provisions of the Declaration of Helsinki (1995). Written informed consent was obtained from each participant.
In the qualitative phase of the study, in-depth interviews with individuals in the acupressure group were recorded with a voice recorder.
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
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 65 and over
- •Who completed chemotherapy treatment for cancer at least a month ago
- •Least literate
- •Moderate to severe fatigue (VAS fatigue score 4 and above)
- •Platelet count> 50,000
- •Hemoglobin levels> 9 g / dl
- •Hematocrit levels> 30%
- •Patients with an estimated survival time of more than three months
排除标准
- •Comorbidities that may cause fatigue (eg moderate and severe heart failure, hypothyroidism, diabetes, multiple sclerosis)
- •Being diagnosed with a psychiatric disease
- •Nerve, soft tissue and vascular disease on acupressure areas (hand and leg)
- •Infection and surgery operations on acupressure areas (hand and leg)
- •Patients had chemotherapy, radiotherapy or other cancer treatment planned during the study
结局指标
主要结局
Visual Analog Scale
时间窗: four weeks
The scale is a 10-cm scale starts with a -0- representing "I don't feel tired", the other end is -10- "I feel very tired". 0-3 points show mild fatigue, 4-6 points moderate fatigue, 7-10 points indicate severe fatigue. The patients were asked to mark how tired they were during the last week on a scale of 0 to 10. The distance between the marked point and the lowest end of the line (0 = no fatigue) was measured in centimeters by the ruler and the numerical value was determined as the fatigue score of the patients.
Piper Fatigue Scale
时间窗: four weeks
The scale evaluates the patient's subjective perception of fatigue with four sub-dimensions. These sub-dimensions are behavioral/severity sub-dimension that evaluates effects and intensity of fatigue on daily life activity (DLA), affective meaning sub-dimension that includes emotional meaning attributed to fatigue, sensory sub-dimension that reflects spiritual, physical and emotional symptoms of fatigue and cognitive/mood sub-dimension that reflects the level of effects of fatigue on cognitive functions and state of mind. The high scores obtained from the scale indicate that the perceived fatigue level is high.The validity and reliability study of the scale for the Turkish population was conducted by Can and the cronbach alpha coefficient was found to be 0.94. The cronbach's alpha coefficient in this study was 0.79 in the first follow-up and 0.94 in the second follow-up.
次要结局
未报告次要终点
研究者
ülkü özdemir
assistant professor doctor
TC Erciyes University