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临床试验/NCT04473287
NCT04473287已完成不适用

The Effect of Reflexology Applied to Patients Undergoing Coronary Artery Bypass Graft Surgery on Pain, Anxiety, Fatigue and Sleep: A Randomized Controlled Study

Saglik Bilimleri Universitesi1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2020年9月1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
1
主要终点
Change on pain intensity as measured by Visual Analog Scale

研究概览

简要总结

Coronary artery bypass graft (CABG) surgery is a treatment method that increases survival rate in the treatment of coronary artery disease (CAD). CABG surgery can create anxiety, fear, pain, fatigue, sleep disorders and physiological dysfunctions in patients. Nurses responsible for the care and treatment of patients use pharmacological and non-pharmacological methods to alleviate the problems that arise. In this context, reflexology within complementary and alternative therapy (CAM) can be applied. In this study, it is aimed to evaluate the effect of reflexology applied to patients undergoing coronary artery bypass graft surgery on pain, anxiety, fatigue, sleep and physiological parameters.

详细描述

In the literature, there are a limited number of studies on the effect of reflexology applied on patients undergoing CABG surgery on anxiety and physiological parameters. In addition, no studies on the effect of reflexology on sleep on patients undergoing CABG surgery have been encountered. Anxiety, stress, pain, fatigue, sleep disorders and permanent symptoms may occur in individuals after cardiovascular surgery. It has been determined that with the deterioration in the body system functions and the resulting psychological problems, the blood pressure, heart rhythm and the number of breaths in the individual, respiratory and coughing difficulties due to pain inactivity, body temperature changes, muscle tension, fatigue and even death can occur. With the application of reflexology, the work of the body systems is regulated by providing homeostasis, physiological and psychological relaxation and relaxation are felt with the energy flow that occurs in the body, and toxins are removed from the body. In this study, it is thought that reflexology application to patients undergoing CABG surgery on nursing care will contribute to the nursing literature by examining the effect of reflexology on pain, anxiety, fatigue, sleep and physiological parameters. The population of the study will be the patients who underwent CABG surgery in the Cardiovascular Intensive Care Unit and Cardiovascular Surgery Clinic of Uludağ University Health Practice and Research Center Hospital. The sample will be composed of patients undergoing CABG surgery in Uludag University Health Practice and Research Center Hospital Cardiovascular Surgery Department Cardiovascular Intensive Care Unit and Cardiovascular Surgery Clinic that meet the inclusion criteria. Data will be collected using Personal Information Form, Physiological Parameters Control Form, Visual Analogue Scale, State Anxiety Scale, Richard's Campbell Sleep Scale. The data obtained from the research will be analyzed using the SPSS (Statistical Package for Social Sciences) for Windows 22.0 program. Number, percentage, average and standard deviation will be used as descriptive statistical methods in the evaluation of the data. The t-test will be used to compare quantitative continuous data between two independent groups. Differences between repeated measurements will be analyzed by repeated measurements ANOVA test.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Being between the ages of 18-65
  • •Having undergone CABG surgery for the first time
  • •CABG has not been operated in an emergency
  • •Lack of reflexology history
  • •Not taking inotropic drugs At least 4 hours have passed since the application of the last analgesic drug
  • •Mental insufficiency and no vision, hearing impairment
  • •Place, time and person orientation
  • •Psychological treatment and drug use for this purpose
  • •Participants agree to participate in the research

排除标准

  • •Decreased level of consciousness
  • •Valve repair or replacement during CABG surgery Need for intraaortic balloon and pacemaker
  • •Drainage over 200 ml per hour
  • •Having a history of chronic pain
  • •Being addicted to alcohol and drugs
  • •Bone fractures, sensory disorders, skin infections, skin ulcers in the feet

研究组 & 干预措施

intervention group

Experimental

Reflexology was applied to the intervention group during the procedure for 45 minutes.

干预措施: reflexology practice (Other)

control group

No Intervention

Reflexology was not applied to the control group during the procedure. The control group received standard care and treatment.

结局指标

主要结局

Change on pain intensity as measured by Visual Analog Scale

时间窗: ''just before procedure'' and ''30 minutes after procedure''

The average score change on pain intensity as measured by Visual Analog Scale. This scale is an unidimensional measure commonly used to measure pain intensity. The scale is a measuring tool with length of 0-10 cm. High scores on the scale indicate that pain intensity is high.

Change on fatigue intensity as measured by Visual Analog Scale

时间窗: ''just before procedure'' and ''30 minutes after procedure''

The average score change on fatigue intensity as measured by Visual Analog Scale. This scale is an unidimensional measure commonly used to measure fatigue intensity. The scale is a measuring tool with length of 0-10 cm. High scores on the scale indicate that fatigue intensity is high.

次要结局

  • Score change on anxiety level as measured by State-Trait Anxiety Inventory(''just before procedure'' and ''30 minutes after procedure'')
  • Score change on sleep quality as measured by Richard's Campbell Sleep Scale(''just before procedure'' and ''30 minutes after procedure'')

研究者

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

Elif Gezginci

RN, PhD, Asst Prof.

Saglik Bilimleri Universitesi

研究点 (1)

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