跳至主要内容
临床试验/NCT06023485
NCT06023485招募中不适用

The Effect of Stress Ball Use on Procedural Pain Caused by Subcutaneous Injection in Orthopedic Patients

Kırklareli University2 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2023年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
134
试验地点
2
主要终点
pain management during subcutaneous injection

研究概览

简要总结

Randomization in the study will be done by the researchers with the Randomizer Research program. The research will be carried out between 01.01.2023 and 01.10.2023 with the participation of 134 patients who were hospitalized in the postoperative period at Trakya University Health Research and Application Center Orthopedics and Traumatology Service and participated voluntarily. In the study, in the G.Power 3.1.9.4 program, the effect size was 0.5, the confidence level was 95%, and the power was 80%, and the minimum sample size to be reached was 134 patients (67 experiments- 67 controls), each group consisting of 67 people. Before the study, all patients will be informed by the researchers, and written consent will be obtained from the patients who volunteered to participate in the study. All patients will be asked the questions in the Patient Information Form and the pretest Vizuel Analog Scala (VAS) scores in the Patient follow-up form will be recorded before the subcutaneous (SC) injection application. The patients in the experimental group will be given a stress ball before the SC injection during the routine daytime treatment of the ward at 10:00. The patient will be asked to squeeze the stress ball with his hand on the opposite extremity of the upper extremity where SC injection was applied, counting to five, and then to relax his hand. The level of pain in the area where SC was applied will be evaluated with VAS. For the patients in the control group, 0.4 ml of LMWH will be administered by the nurse in the routine daytime treatment of the service at 10:00, according to the doctor's request. During the patient's drug administration and 2 minutes after the application. The level of pain in the area where SC was applied will be evaluated with VAS.

详细描述

The ramdomized research will be carried out between 01.01.2023 and 01.10.2023 with the participation of 134 patients who were hospitalized in the postoperative period at Trakya University Health Research and Application Center Orthopedics and Traumatology Service and participated voluntarily. In the study, in the G.Power 3.1.9.4 program, the effect size was 0.5, the confidence level was 95%, and the power was 80%, and the minimum sample size to be reached was 134 patients (67 experiments- 67 controls), each group consisting of 67 people. The study included 18 patients who were hospitalized in the orthopedics and traumatology clinic, were in the post-operative period, were not diabetic, conscious, cooperative and oriented (without delirium, etc.), without a diagnosis of psychiatric disease, who could localize the pain, did not undergo upper extremity surgery, and volunteered to participate in the study. Age and older patients will be included. Before the study, all patients will be informed by the researchers, and written consent will be obtained from the patients who volunteered to participate in the study. All patients will be asked the questions in the Patient Information Form and the pretest Vizuel Analog Scala (VAS) scores in the Patient follow-up form will be recorded before the subcutaneous (SC) injection application. The patients in the experimental group will be given a stress ball before the SC injection during the routine daytime treatment of the ward at 10:00. The patient will be asked to squeeze the stress ball with his hand on the opposite extremity of the upper extremity where SC injection was applied, counting to five, and then to relax his hand. In the meantime, 0.4 ml of LMWH will be administered by SC route according to the doctor's request. During the patient's drug administration and 2 minutes after the application. The level of pain in the area where SC was applied will be evaluated with VAS. For the patients in the control group, 0.4 ml of LMWH will be administered by the nurse in the routine daytime treatment of the service at 10:00, according to the doctor's request. During the patient's drug administration and 2 minutes after the application. The level of pain in the area where SC was applied will be evaluated with VAS. Unlike the control group, the patients in the experimental group will be asked to tighten and loosen the stress ball during SC injection

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)

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

  • patients;
  • who were hospitalized in the orthopedics and traumatology clinic,
  • who were in the post-operative period,
  • who were not diabetic,
  • who were conscious,
  • who were cooperative and oriented (without delirium, etc.),
  • who were not diagnosed with psychiatric disease,
  • who could localize pain,
  • who did not undergo upper extremity surgery, and
  • who volunteered to participate in the study.

排除标准

  • Patients who do not volunteer to participate in the study will not be included.

结局指标

主要结局

pain management during subcutaneous injection

时间窗: 9 months

The patient will be asked to squeeze the stress ball with his hand on the opposite extremity of the upper extremity where SC injection was applied, counting to five, and then to relax his hand. In the meantime, 0.4 ml of LMWH will be administered by SC route according to the doctor's request. During the patient's drug administration and 2 minutes after the application. The level of pain in the area where SC was applied will be evaluated with Vizuel Analog Scala (VAS). The VAS is a unidimensional scale frequently used to measure pain severity. The scale consists of a 10-cm demarcated line in which 0 cm represents no pain and 10 cm represents unbearable pain.

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

Figen Dıgın

Assistant Professor

Kırklareli University

研究点 (2)

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