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临床试验/NCT05103163
NCT05103163已完成不适用

The Effect of Foot Reflexology on Patient Satisfaction, Pain, and Vital Signs After Abdominal Surgery

Gurkan Kapikiran2 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2020年10月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
156
试验地点
2
主要终点
Pulse measurement

研究概览

简要总结

Reflexology practice is an effective method in pain control by stimulating the release of endorphins. The study was conducted to determine the effect of foot reflexology applied to patients undergoing abdominal surgery on pain, patient satisfaction and vital signs. The study was conducted in a randomized controlled manner. The population of the study consisted of adult patients who underwent abdominal surgery in a university hospital in Turkey. The sample consisted of 156 patients with the indicated power analysis, including the analysis 78 experimental and 78 controls. Data were collected between October 2020 and May 2021 using Personal Information Form, Numerical Pain Scale, Newcastle Nursing Care Satisfaction Scale and Vital Signs Registration Form.

详细描述

This study was conducted in a randomized controlled experimental setup. This research was conducted in the general surgery clinic of a university hospital in Turkey between October 2020 and May 2021.

The universe of the research; consisted of 261 patients aged 18 years and over who underwent abdominal surgery in the general surgery ward of a university hospital. The G Power 3.1.9.7 computer program was used to calculate the sample size. According to this program, it was determined that a total of 156 patients, 78 patients in each group, should be reached, with an effect size of 0.4, a margin of error of 0.04, a confidence interval of 0.95, and a population representation power of 95%. 57 patients who did not meet the inclusion criteria and 48 patients who did not volunteer to participate in the study were not included in the sample.

Which of the patients included in the study would be in the experimental group and which would be in the control group was made according to the randomization table determined by the web-based random assignment software (RAY). There are two columns in the table as group 1 and group 2. Which column would be in the experimental group and which would be in the control group was determined by drawing lots. As a result of the draw, it was determined that group 1 would be in the control group and group 2 would be in the experimental group. Then, group assignments were made in accordance with the randomization order determined by RAY.

In the collection of data; "personal information form", "numerical pain scale", "newcastle nursing care satisfaction scale" and vital signs registration form were used.

Data were collected by the first researcher by face-to-face interview method between October 2020 and May 2021. Patients who met the inclusion criteria were recruited three days a week and on weekends after surgery.

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 (Participant)

盲法说明

Which of the patients included in the study would be in the experimental group and which would be in the control group was determined according to the randomization table determined by the web-based random assignment software (RAY). There are two columns in the table as group 1 and group 2. Which column would be in the experimental group and which would be in the control group was determined by drawing lots. As a result of the draw, it was determined that group 1 would be in the control group and group 2 would be in the experimental group. Then, group assignments were made in accordance with the randomization order determined by RAY.

入排标准

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

入选标准

  • 18 years of age and above who are open to communication,
  • Hospitalized for at least two nights
  • Defining the severity of pain as 4 and above,
  • Any lesion, wound, infection, etc. that prevents the practice of standing reflexology. non,
  • Not diagnosed with cancer
  • Deep vein thrombosis, epilepsy, Thrombophlebitis, febrile diseases etc. without diseases,

排除标准

  • Presence of any lesion, wound, infection etc. on the foot
  • Presence of deep vein thrombosis
  • Presence of epilepsy
  • With thrombophlebitis and febrile diseases
  • Those who do not volunteer to participate in the study,

结局指标

主要结局

Pulse measurement

时间窗: 0.-30. minutes

The patient's heart rate in 1 minute was measured.

oxygen saturation measurement

时间窗: 0.-30. minutes

Oxygen saturation was measured with a pulse oximeter device.

Patient Satisfaction

时间窗: 0-30 minutes

It is a Likert-type scale, scored between 1 and 5, consisting of 19 questions containing patients' views of satisfaction with nursing care.

Respiratory rate measurement

时间窗: 0.-30. minutes

The respiratory rate of the patient in 1 minute was measured.

Pain Level

时间窗: 0.-30. minutes

It is a numeric scale which is based on explaining pain severity with numbers, and where 0 point means no pain and 10 points mean unbearable pain

Blood pressure measurement

时间窗: 0.-30. minutes

Systolic blood pressure was measured with a digital sphygmomanometer (mm Hg).

次要结局

未报告次要终点

研究者

发起方
Gurkan Kapikiran
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Gurkan Kapikiran

Assistant Professor

Inonu University

研究点 (2)

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