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临床试验/NCT04516356
NCT04516356已完成不适用

The Effects of Korean Hand Acupressure on Postoperative Nausea-Vomiting and Retching After Thyroidectomy

Sevgi Gür1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2021年2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
发起方
入组人数
42
试验地点
1
主要终点
Postoperative pain severity

研究概览

简要总结

The study was planned as a randomized controlled experimental study to determine the effect of Korean hand acupressure applied after thyroidectomy on postoperative nausea-vomiting and retching. After ethics committee approval and institutional permission, 42 patients who applied to the general surgery clinic for thyroidectomy between February 1, 2021 and June 1, 2022 and met the inclusion criteria were included in the study. In the light of academic studies reported within the scope of the planned study, the sample size was determined with the effect size d = 0.942 (effect size), α = 0.05 ( margin of error), 1-β = 0.90 (Power) and G-power package program. It was decided to recruit 42 people (21 people per group). The block randomization method was used to determine the experimental and control groups. Randomization was done by a biostatistician other than the researcher. Patients who met the inclusion criteria and agreed to participate in the study were assigned to the experimental and control groups according to the randomization list. Before the operation, the patient was visited and informed about the purpose, content and the intervention to be applied. After obtaining verbal and written consent from the patients who agreed to participate in the study, the "Individual Characteristics Form" was filled. The first part of the "Patient Follow-up Form" was filled in the experimental and control groups on the day of surgery. Korean hand acupressure was applied to the experimental group 30 minutes before the induction of anesthesia. After determining the pressure/treatment points on the patient's hand due to nausea and vomiting, a 3-5 minute massage was performed with the diagnostic stick. The seeds were then fixed at these points with a paper patch. The seeds were not removed for 8 hours. Massage was done for 3-5 minutes by pressing the seeds every 2 hours and making a curling motion at the same time. At the end of the 8th hour, the application was terminated. The application was made by Sevgi Gür, a researcher trained in Korean hand acupressure. In the control group, no application will be made during and after the surgical intervention, and routine treatment and care was applied. Pain, severity of nausea and vomiting, number of nausea-vomiting and retching, name, dose, frequency and duration of antiemetic drugs used were determined by the researcher at the 2nd, 6th, 12th and 24th hours after the patients in the experimental and control groups applied to the clinic. It was recorded in the second part of the "form". At the end of the 24th hour, the Rhodes Nausea, Vomiting and Retching Index score was evaluated by the researcher.

详细描述

The universe of the research; patients scheduled for thyroidectomy between February 1, 2021 and June 1, 2022, in the general surgery clinic where the study will be conducted, constituted patients who met the inclusion criteria and agreed to participate in the study. The study was planned as a randomized controlled experimental study. The block randomization method was used to determine the experimental and control groups. Randomization was done by a biostatistician other than the researcher. Patients who met the inclusion criteria and agreed to participate in the study were assigned to the experimental and control groups according to the randomization list. Research data were collected in the general surgery ward of a hospital from February 1, 2021 to June 1, 2022. The independent variable of the research is Korean hand acupressure. The dependent variables of the study were postoperative nausea-vomiting and retching (number and severity), pain severity (Visual Analog Scale-VAS), Rhodes nausea-vomiting and retching index score average. In the study, "Individual Characteristics Form" and "Patient Follow-up Form" prepared by the researcher in line with the literature were used as data collection tools.

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
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

  • •Between the ages of 18-65,
  • •According to the American Association of Anesthesiologists (ASA) classification; ASA score I and II,
  • •Elective surgery,
  • •Individuals with 2 or more risk factors out of 5 risk factors determined in Koivuranta PONV risk factors
  • •Patients who agree to participate in the study will be included in the study.

排除标准

  • •Emergency surgery,
  • •Using antiemetic, steroid or opioid 24 hours before surgery,
  • •Not agreeing to participate in the research
  • •Change in consciousness / acute confusion after surgical intervention,
  • •Has a mental or psychiatric illness that prevents communication,
  • •Patients whose post-operative condition is unstable will not be included in the study.

研究组 & 干预措施

Intervention Arm

Experimental

Korean hand acupressure will be applied to the experimental group 30 minutes before the induction of anesthesia. After determining the pressure / therapy points associated with nausea and vomiting on the patient's hand, a massage will be made for 3-5 minutes with a diagnostic stick. The seeds will then be fixed at these points with a paper patch. Seeds will not be removed for 24 hours. It will be massaged for 3-5 minutes by pressing the seeds every 3-4 hours and making a curling motion at the same time. At the end of the 24th hour, the application will be terminated.

干预措施: Korean hand acupressure (Other)

Control Arm

No Intervention

In the control group, no application will be made during and after the surgical intervention, and routine treatment and care will be applied.

结局指标

主要结局

Postoperative pain severity

时间窗: Reported pain severity in the first 24 hours after surgery

Pain severity assessment with Visual Assessment Scale (VAS) Score: 0-10; 0- No Pain, 10- Worst pain

Use of antiemetics

时间窗: In the first 24 hours after surgery

The name, dose, frequency and time of the antiemetic drugs

Postoperative nausea and vomiting severity

时间窗: Reported nausea and vomiting severity in the first 24 hours after surgery

Nausea and vomiting severity with Visual Assessment Scale (VAS) Score: 0-10; 0- None, 10- Agonizing

The number of postoperative nausea, vomiting and retching

时间窗: Reported the number of nausea, vomiting and retching in the first 24 hours after surgery

The number of nausea, vomiting and retching

Rhodes Nausea Vomiting and Retching Index score

时间窗: At the end of the 24th hour after surgery

Evaluation of Rhodes Nausea Vomiting and Retching Index score In order to score the scale, responses to items 1, 3, 6 and 7 are calculated in reverse order; For each answer, they are scored as 0: minimum, 4: most discomfort, and the score obtained from 8 items is added. It is expressed as 32 points, the highest possible value.

次要结局

  • Postoperative complications(End of surgery to hospital discharge 5-7 days)

研究者

发起方
Sevgi Gür
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sevgi Gür

Lecturer

Istanbul University - Cerrahpasa (IUC)

研究点 (1)

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