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临床试验/NCT06120101
NCT06120101已完成不适用

Examining the Effect of Foot Reflexology Massage on Seizure Frequency, Fatigue, Stress and Sleep Quality in Epilepsy Patients: Randomized Control Experimental Research

Ataturk University2 个研究点 分布在 2 个国家目标入组 70 人开始时间: 2023年8月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
2
主要终点
Perceived Stress Scale (PSS)

研究概览

简要总结

Epilepsy is among the diseases that cause loss of neurological abilities regardless of any trauma. Reflexology is one of the complementary therapies based on activating the body's self-healing power through special hand techniques applied to the feet. It is known that there are positive changes in seizure frequency, fatigue, stress and sleep quality in epilepsy patients after reflexology. This study will be conducted to determine the effect of reflexology on seizure frequency, fatigue, stress and sleep quality in epilepsy patients.

详细描述

Individual interviews were conducted with epilepsy patients who applied to the neurology clinic of a university hospital where the research was conducted, and patients who met the inclusion criteria and agreed to participate in the study will be randomly included in the experiment.

Patients arriving on the first day of the week will be placed in the experimental group. In the following days, groups will be formed as one day experiment and one day control (Monday-experiment, Tuesday-control, Wednesday-experiment, Thursday-control, Friday-experiment). Data collection tools will be applied to the experimental and control group patients at the beginning and end of the study. Only reflexology massage will be applied to the experimental group, and no application will be applied to the control group. Data will be collected simultaneously with the control and experimental groups.

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Knowing the diagnosis of the disease
  • Having not received reflexology therapy before
  • Being literate in Turkish
  • Conscious Open,
  • Able to communicate verbally,
  • Being 18 years or older

排除标准

  • Pain starts while doing massage,
  • Having an infection,
  • High fever,
  • Having clot problems in the leg veins,
  • Having an acute (newly developing) disease (heart attack, fainting, etc.),
  • Wounds in the application area,
  • Patients in the first 3 months of pregnancy.
  • Paraplegia or thrombosis
  • Leg varicose veins or foot disease (open wound or fracture on the foot)
  • Diagnosis of psychiatric disorder or dementia

研究组 & 干预措施

Experimental

Experimental

Reflexology will be applied in a total of 3 sessions and the final test will be applied to the patients by phone 24 hours after the last reflexology application. At the end of the study, 3 reflexology sessions and 2 test measurements will be performed on the experimental group. Each reflexology session takes approximately 30-40 minutes. Sessions will be performed in a private room within the neurology clinic, on ergonomic and repositionable beds. Each session started with the right foot and will continue with the left foot. Primary relaxation techniques will be applied to both feet, followed by reflexology techniques to all system organs.

干预措施: Reflexology Massage (Behavioral)

Control

No Intervention

No application will be applied to the control group.

结局指标

主要结局

Perceived Stress Scale (PSS)

时间窗: Two week

It was developed by Cohen, Kamarck \& Mermelste in 1983, and its Cronbach Alpha value was found to be 0.86 in the reliability study. In this study, the scale adapted to Turkish by Bilge, Öğce, Genç and Oran (2007) was used, and the Cronbach Alpha value was found to be 0.81 in the reliability study. Three items of the scale prepared in a 5-point Likert type (0 never, 4 very often) are reverse-worded (items 4, 5, 6), and five items are literal (items 1, 2, 3, 7, 8). ). A total score of 0-32 is taken from the scale. It has two subscales: perceived stress (items 1, 2, 3, 7, 8) and perceived coping (items 4, 5, and 6). The scale is evaluated on both total score and subscale scores. A high total score means a high perceived stress level. High scores from the subscales are a negative situation.

Chalder Fatigue Scale (CFA)

时间窗: two week

Individuals' fatigue level was evaluated with the CSI developed by Trudie Chalder in 1993. CWS is an 11-item scale that evaluates the fatigue felt by individuals during the last month through self-report. CEX consists of physical fatigue and mental fatigue subscales. A four-point Likert scale is used in the evaluation.

Pittsburg Sleep Quality scale (PSQI)

时间窗: Two week

The scale developed by Buysse et al., Turkish reliability and validity study by Ağargün et al. (Ağargün MY, Kara H, 1996). Made by. The scale, which examines the individual's sleep quality in the last month, consists of 24 items. Each question is evaluated with a number from 0 to 3. The highest score that can be obtained from the scale is 21. An increase in the score obtained from the scale indicates that sleep quality is poor.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

NİHAN TÜRKOĞLU

Assist Prof.

Ataturk University

研究点 (2)

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