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临床试验/NCT07061340
NCT07061340尚未招募不适用

The Effect of Therapeutic Touch on Agitation, Pain, and Cortisol Levels in Intensive Care Patients: A Randomized Controlled Study

Firat University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年12月31日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
2
主要终点
Richmond Agitation-Sedation Scale

研究概览

简要总结

Intensive care units (ICU) are special clinical areas where advanced monitoring and treatment of patients with life-threatening organ failure or those at risk of developing organ failure are carried out, with high technological equipment and a multidisciplinary approach is adopted. Agitation, pain, anxiety and hormonal imbalances are frequently observed due to hospitalization in ICU. In this stressful environment, patients often experience pain and agitation. Both situations trigger a physiological stress response in the patient and increase cortisol secretion. This increase in cortisol levels can suppress the immune system, delay wound healing and negatively affect the patient's general prognosis. Today, in addition to modern medicine, complementary/alternative therapies are increasingly used. One of these alternative therapies is therapeutic touch application. Therapeutic touch is based on the therapeutic effect of the act of touching. Therapeutic touch, alternatively known as healing touch, is a complementary/alternative treatment method applied by touching energy points on the body. Therefore, this study was planned to examine the effects of therapeutic touch applied to patients in intensive care on pain, agitation and cortisol levels. This study, planned as a randomized experimental study with a pre-test-post-test intervention control group, will consist of patients in the Intensive Care Unit of Fırat University Hospital. The sample will consist of 60 intensive care patients, 30 in the intervention group and 30 in the control group, who meet the research criteria on the specified dates and accept the research. The patients in the intervention and control groups will first be informed about the application before starting the application and their verbal and written consents will be obtained. Then, the intervention group will be given the Patient Identification Form, Richmond Agitation-Sedation Scale (RASS), Visual Analog Scale (VAS), cortisol levels from laboratory data will be recorded and therapeutic touch will be applied and after the application, the RASS and VAS scales will be filled again and the blood cortisol levels will be checked. This process will be done before and after each application and a total of 8 measurements will be taken. The application will take approximately 15-30 minutes every four days for the patients in the intervention group. During this period, no application will be made to the patients in the control group and RASS, VAS scales will be filled every four days and blood cortisol levels will be checked. Thus, a total of 8 measurements will be obtained. In the analysis of the data; frequency and percentage analyses, chi-square analysis, standard deviation, t-test in dependent groups, t-test analysis in independent groups will be performed.

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 (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18 years and above.
  • Patients who can communicate verbally.
  • Patients who have been monitored in the intensive care unit for at least 4 days.
  • Patients who are able to give informed consent.
  • Patients who are hemodynamically stable.
  • Richmond Agitation-Sedation Scale 1 and above.
  • Visual Analog Scale 1 and above.

排除标准

  • Patients under deep sedation.
  • Patients on mechanical ventilation.
  • Patients with psychiatric problems.
  • Patients with skin diseases or open wounds, infections, burns that would prevent therapeutic touch.
  • Patients using sedative/analgesic drugs (excessive sedation or delirium).
  • Patients using corticosteroids or drugs that affect adrenal hormone levels (because these drugs can affect cortisol measurements).
  • Patients who have sudden life-threatening clinical changes during intensive care (e.g. sudden cardiac arrest, shock).

结局指标

主要结局

Richmond Agitation-Sedation Scale

时间窗: After application,about 1 hour later

The Richmond Agitation-Sedation Scale is a highly reliable and valid assessment tool developed to assess the agitation and sedation levels of intensive care patients. The scale is scored between -5 (deep sedation) and +4 (severe agitation) according to the patients' reactions to environmental stimuli. Individuals with a scale score of "0" are considered alert and calm, while negative scores indicate the depth of sedation and positive scores indicate the severity of agitation. It is widely preferred in clinical practice because it can be applied in a short time and can be used in an integrated manner with nursing care

Visual Analog Scale

时间窗: After application,about 1 hour later

The scale is frequently used in the assessment phase of pain intensity. Patients are asked to indicate the intensity of pain during activity or rest on a 10 cm long vertical or horizontal line. The line has a value of 0 at the beginning and 10 at the end. 10 means unbearable pain, and 0 means no pain at all. While the patient marks the pain they feel on this line, each point they mark is measured in cm.

Blood Cortisol Level

时间窗: After application,about 1 hour later

To be taken from patient records

Richmond Agitation-Sedation Scale

时间窗: After application,about 1 hour later

The Richmond Agitation-Sedation Scale is a highly reliable and valid assessment tool developed to assess the agitation and sedation levels of intensive care patients. The scale is scored between -5 (deep sedation) and +4 (severe agitation) according to the patients' reactions to environmental stimuli. Individuals with a scale score of "0" are considered alert and calm, while negative scores indicate the depth of sedation and positive scores indicate the severity of agitation. It is widely preferred in clinical practice because it can be applied in a short time and can be used in an integrated manner with nursing care

Blood Cortisol Level

时间窗: After application,about 1 hour later

To be taken from patient records

次要结局

未报告次要终点

研究者

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

Gülcan Bahçecioğlu Turan

Principal Investigator

Firat University

研究点 (2)

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