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临床试验/NCT06417047
NCT06417047已完成不适用

Effect of Hand Holding on Reducing Intramuscular Injection-Induced Pain and Anxiety: A Randomized Controlled Study

Necmettin Erbakan University1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2024年7月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
104
试验地点
1
主要终点
Numerical Pain Scale

研究概览

简要总结

It was aimed to examine the effect of the hand holding method applied during intramuscular injection on pain and anxiety.

详细描述

This study was designed as a pre-test-post-test regular parallel group, randomized controlled experimental design. The research will be carried out in the Adult Emergency Service of the Ministry of Health of the Republic of Turkey, Konya City Hospital. Patients will be randomly divided into two groups: handholding (52) and control group (52). For the Hand Holding Group: After the patient is positioned appropriately, the patient's hand will be held by the researcher. Once the intramuscular injection is completed, the patient's hand holding will be stopped. For the Control Group: No application will be made during intramuscular injection in the control group. The primary outcome of this study is to determine patients' pain scores during the intramuscular injection procedure. The secondary outcome is to determine the anxiety levels of patients.

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
Double (Participant, Outcomes Assessor)

盲法说明

Double (Participant, Outcomes Assessor) The patients will be informed about the study and their consent will be obtained without explaining which group they are in. Since the researcher manages the implementation process of the study, researcher blinding cannot be done. In addition, it will be ensured that the researcher learns which group the patients are in after the patients accept to participate in the study. Thus, the internal validity of the research will be ensured.

At the same time, blind technique will be applied in terms of statistical analysis in the research. The data will be recorded on the computer by the researcher without using the expression of experimental and control groups, and data analysis will be done by another statistician other than the person who made the randomization.

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

入选标准

  • Having vitamin B 12 1000 mcg/ml (1 ml ampoule) intramuscular treatment,
  • Being literate,
  • Are between the ages of 18-65,
  • No visual, hearing, sensory or motor loss or cognitive impairment,
  • Not using centrally or peripherally acting analgesics or sedatives,
  • There is no scar tissue, incision, lipodystrophy or signs of infection on the skin of the injection area,
  • Having a body mass index between 18.5 and 29.5,
  • Injected into the ventrogluteal area,
  • Individuals who agree to participate in the research will be included.

排除标准

  • Those with chronic pain,
  • Having a psychiatric disorder,
  • Foreign nationals,
  • Patients with contact-communicable diseases will be excluded from the study.

结局指标

主要结局

Numerical Pain Scale

时间窗: It will be filled within 1 minute after the intramuscular injection is completed.

A score of "0" indicated the lowest pain, and a score of "10" indicated the highest pain.

次要结局

  • State Anxiety Scale(It will be filled immediately before the intramuscular injection and within 1 minute after the procedure is completed.)

研究者

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

Serpil SU

Assistant professors

Necmettin Erbakan University

研究点 (1)

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