The Effect of Therapeutic Touch on Sleep Quality and Fatigue Severity in Advanced Cancer Patients in the Palliative Care Setting: A Randomized Controlled Trial
概览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Sleep Quality
概览
简要总结
This study aims to examine the effect of therapeutic touch applied to advanced cancer patients receiving palliative care on sleep quality and fatigue severity. This is a randomized controlled experimental study using a pretest-posttest design. The study includes advanced-stage cancer patients receiving support in a palliative care unit. Research data will be collected from patients between March and August 2024 using face-to-face interviews. The intervention group will receive therapeutic touch for 20 minutes per day for 5 consecutive days, while the control group will continue to receive routine palliative care. Data will be collected using a Personal Information Form, the Richards-Campbell Sleep Questionnaire (RCSQ), and the Fatigue Severity Scale (FSS).
详细描述
Palliative care is a branch of healthcare that helps individuals who cannot achieve complete remission due to chronic diseases, mostly cancer, or who need care in the last period of life, to manage the multiple symptoms brought by the disease. The majority of cancer patients receiving palliative care treatment are in advanced cancer stages. The aim of treatment in cancer patients receiving palliative care is to improve quality of life and to manage pain, insomnia, fatigue, and other symptoms related to the disease. One of the most common problems experienced by these patients is insomnia and fatigue due to both treatment and the nature of the disease. These patients use many integrative methods as well as many medical treatments. One of these methods is therapeutic touch. The fact that this method has no known side effects makes it an attractive option for symptom management.
In the hospital setting, therapeutic touch can be applied in the patient's room and bed. After disinfecting the hands and bringing them to body temperature, the practitioner applies light, rhythmic touches to the patient's head, shoulders, arms, and feet. During this application, patients are asked to be in the most comfortable position. The therapeutic touch session for sleep, which is one of the variables of the study, should be performed close to the patient's bedtime (approximately 22:00). The application takes approximately 10-15 minutes.
Materials and Methods
The research is a randomized controlled experimental study with a pretest-posttest design. Randomization will be ensured by using a simple random number table.
Location of the Study: The study will consist of cancer patients receiving care and treatment services in the Palliative Care Service of Erzurum City Hospital, affiliated with the Ministry of Health of the Republic of Turkey.
Study Population and Sample Selection: Using G*Power 3.1.7 software, the sample size was calculated with a test power of 0.95. As a result of the analysis, it was determined that 30 patients should be included at the α=0.05 level, when the effect size was 0.10 and 95% power.
Implementation Protocol: After randomization, patients will be divided into two groups. Scales will be applied to the intervention group in the first interview and pretest data will be obtained. Therapeutic touch will be performed on the head, shoulders, hands, and feet for approximately 10-15 minutes, starting at 22:00, for 5 consecutive days.
Control Group: Patients in the control group will be interviewed at 22:00, and a sociodemographic questionnaire, the Richards-Campbell Sleep Questionnaire (RCSQ), and the Fatigue Severity Scale (FSS) will be administered. The data collection phase of the study will be completed by collecting posttest data from all groups after the last interview.
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
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •18 years of age or older
- •Pathologically confirmed advanced-stage cancer (stage 3-4)
- •Receiving palliative care treatment
- •Richards-Campbell Sleep Questionnaire (RCSQ) score ≤50
- •Fatigue Severity Scale (FSS) score ≥4
- •Mini-Mental Test score ≥24
排除标准
- •Known diagnosis of a major sleep disorder
- •Presence of acute infection
- •Widespread dermatological lesions compromising skin integrity (e.g., ulcer, eczema)
- •Dementia, delirium, or severe cognitive impairment
- •Hearing or vision loss that would hinder therapeutic communication
- •Medical condition that would contraindicate the application as determined by the palliative care team
研究组 & 干预措施
therapeutic touch intervention group
Scales were applied to the intervention group in the first interview and pre-test data were obtained. In the next process, therapeutic touch was performed to the intervention group for approximately 10-15 minutes on the head, shoulders, hands and feet starting at 22:00 at night for 5 days on weekdays within the scope of the research.
干预措施: Therapeutic Touch (Behavioral)
Control: Routine Palliative Care Group
Control group continued with routine palliative care protocols. No therapeutic touch or other specific touch-based intervention was applied. Scales were applied at the same time points as the intervention group.
干预措施: Routine Palliative Care (Other)
结局指标
主要结局
Sleep Quality
时间窗: Baseline and immediately after 5-day intervention
Sleep quality measured by the Richards-Campbell Sleep Questionnaire (RCSQ). The scale consists of 5 items scored from 0 to 100. Higher scores indicate better sleep quality.
次要结局
- Fatigue Severity(Baseline and immediately after 5-day intervention)
研究者
Ercan Bakır
Associate Professor
Erzurum Technical University