Use of Handheld Fans in Management of Hot Flashes in Women With Breast Cancer Receiving Hormonetherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Visual Analog Scale (VAS)
研究概览
简要总结
Hot flushes are a common symptom in women with breast cancer receiving hormone therapy. It can lead to conditions that reduce quality of life such as sleep quality deterioration, sexual problems and discomfort in daily life. Effective management of the symptom improves the quality of life of patients.
The aim of the study was to examine the effect of handheld fan use in the management of hot flashes in women with breast cancer receiving hormone therapy.
Hypotheses of the research:
H1: Handheld fan use has no effect in managing hot flashes in women with breast cancer receiving hormone therapy. H2: The use of handheld fan has an effect on the management of hot flashes in women with breast cancer receiving hormone therapy. This randomised controlled study was a pretest-posttest experimental design. The study sample consisted of 64 breast cancer patients (n = 32 for each of the intervention and control groups) receiving hormone therapy treatment in the medical oncology department of a university hospital. The intervention group used a hand-held fan when experiencing hot flush symptoms, while the control group did not receive any intervention. The pre-test and post-test Visual Analogue Scale (VAS) and hot flush belief scale scores and the results of the individual identifying information form were compared for both groups.
详细描述
Study Design This study was conducted in a single-blind, single-center, randomized controlled design in breast cancer patients receiving hormone therapy in an outpatient chemotherapy unit.
This study was conducted in the outpatient chemotherapy unit of a training and research university hospital in Turkey Participants Power analysis was performed to determine the sample size of the study and the power of the test was calculated with G*Power 3.1 programme. Accordingly, with a margin of error of α=.05 and 80% power level, a total of 52 people, 26 people in each group, were found sufficient. This number was increased by 20% in case there were patients who wanted to leave the study. Patients were assigned to the control (n=32) and intervention groups (n=32) by simple randomisation.
The inclusion criteria were patients aged 18 years and over, diagnosed with breast cancer, receiving active hormone therapy, experiencing hot flush symptoms and volunteering to participate in the study. Patients who were in menopause and had verbal and auditory communication problems were excluded from the study.
Randomisation A total of 90 patients who met the inclusion criteria were reached. Since 10 of the 90 patients did not meet the inclusion criteria, 80 patients were assigned to the groups by simple randomisation (40 in the intervention group and 40 in the control group). In order to minimise selection bias, a table of random numbers from the simple random sampling method, which is one of the probability sampling methods, was used. Since 5 of the 40 patients randomly assigned to the intervention group refused to participate in the study and 3 of them continued to receive treatment in another hospital, the study was terminated with 32 patients. Of the 40 patients randomly assigned to the control group, the study was terminated with a total of 32 patients because 6 refused to participate in the study and 2 left due to interruption of treatment.
Measurements Research data were collected using the "Individual Information Form", "Visual Analog Scale (VAS)" and "Hot Flash Belief Scale" prepared by the researchers in line with the literature. Individual Information Form; the form prepared by the researchers consisted of 13 questions regarding the individuals' age, gender, place of residence, number of children, marital status, educational status, employment status, economic status, chronic disease status, duration of cancer diagnosis, cancer stage, treatments received, and practices performed to prevent symptoms15.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Single (Participant)
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
- •Diagnosis of clinical breast cancer
- •Experiencing hot flashes
排除标准
- •Menopausal women
结局指标
主要结局
Visual Analog Scale (VAS)
时间窗: 12 weeks
Visual Analog Scale (VAS); VAS is used to quantify some values that cannot be measured numerically. It consists of a 10 cm long line at one end, which is expressed as very good for the individual/patient and very bad at the other end. VAS is also a valid and reliable measurement tool for measuring other subjective emotions such as mood. In this study, VAS is preferred for the hot flashes experienced by women with breast cancer receiving hormone therapy
Hot Flashes Belief Scale
时间窗: 12 weeks
The scale consists of 27 items and three sub-dimensions. The beliefs about oneself in a social context sub-dimension: It was formed with 13 items (1, 6-11, 13, 14, 17, 20, 21, 23) that describe how women feel when they experience hot flashes in social environments. The beliefs about coping with hot flashes sub-dimension: It was formed with 10 items (2, 5, 12, 15, 16, 18, 19, 24, 26, 27) that describe beliefs about coping with hot flashes. Beliefs about coping with night sweats sub-dimension: It consists of 4 items (3, 4, 22, 25) describing women's beliefs about coping with night sweats. Each item of the scale is rated on a 6-point Likert type scale ranging from "strongly disagree" (0 points) to "strongly agree" (5 points). It is stated that items 2, 4, 5, 11, 15, 18, 25 of the scale are reverse coded. The total score of the scale varies between 0-135, and a high score on the scale indicates a high level of negative belief.
Individual Information Form
时间窗: 12 weeks
This form contains questions about sociodemographic characteristics, diseases and symptoms.
次要结局
未报告次要终点
研究者
Aslıhan ÖZTÜRK ÇETİN
Principal Investigator
Izmir Bakircay University
