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临床试验/NCT06864923
NCT06864923尚未招募不适用

Investigation of the Effect of Hot Foot Bath on Sleep Quality and Fatigue

Uludag University0 个研究点目标入组 60 人开始时间: 2025年3月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
主要终点
fatigue severity in score (0-10)

研究概览

简要总结

This study will be conducted to investigate the effects of hot foot baths on patients' sleep quality and fatigue severity levels.The study will be conducted in the Gastroenterology clinic of a university hospital in Türkiye. The research sample will consist of 60 adult patients. Patients will be randomly divided into two groups: the intervention and control groups. The intervention group will receive hot foot baths for three consecutive nights starting from the second day of hospitalization. The foot bath will be applied one hour before the patient goes to bed at night. The foot tub will be filled with hot water to approximately 20 cm above the patient's ankle and the temperature of the water will be measured with a water thermometer. The temperature of the water will be kept stable at 41-42°C. This application will be done for 20 minutes. The sleep and fatigue levels of the patients will be measured with measurement tools in the morning (3 times) following each application. No application will be applied to the control group, and sleep and fatigue levels will be measured in a similar manner to the measurement tools applied to the intervention group and the application days.

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
Single (Investigator)

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •being over the age of 18,
  • •having no disorder which could affect pain perception,
  • •having no communication problem, and voluntarily agreeing to participate in the research,
  • •Having been admitted to the clinic at least 24 hours ago,
  • •Not having a diagnosed sleep disorder,
  • •Not having a psychiatric disorder requiring treatment,
  • •Not having a problem with vital signs before the application,
  • •Not using narcotic drugs in the last 4 hours,
  • •Not eating two hours before going to bed at night

排除标准

  • •being under the age of 18
  • •not being conscious, refusing to participate in the research or opting to leave the study at any point,
  • •Having a problem with vital signs before the application,
  • •Having a diagnosed sleep disorder.

研究组 & 干预措施

Hot foot bath application group

Experimental

干预措施: Hot foot bath application group (Other)

Control group

No Intervention

结局指标

主要结局

fatigue severity in score (0-10)

时间窗: 4 months

Brief Fatigue Inventory: Scoring ranges from "0" to "10", with "0" indicating no effect and "10" indicating the highest level of effect. The general fatigue score is calculated by dividing the total score of items 1, 2 and 3 by 3, and the effect score of fatigue on daily living activities is calculated by dividing the total score of items 4a, 4b, 4c, 4d, 4e and 4f by 6. A score of "0" obtained from the KYE indicates no fatigue, "1-3" indicates low fatigue, "4-6" indicates moderate fatigue, "7-9" indicates high fatigue and "10" indicates the highest level of effe

Sleep Quality in score

时间窗: 4 months

Sleep Quality Scale: It consists of a total of 18 items. It includes items related to the sleep process and sleep satisfaction.

次要结局

  • weight(4 months)

研究者

发起方
Uludag University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dilek Yilmaz, PhD

Associate Professor, Bursa Uludag University, Department of Nursing

Uludag University

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