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临床试验/NCT06645457
NCT06645457已完成不适用

The Effect of Stress Ball and 4-7-8 Breathing Technique on Pre-Procedure Fear, Anxiety and Physiological Parameters in Elderly Patients Undergoing Endoscopy: Randomized Controlled Study

Kafkas University2 个研究点 分布在 2 个国家目标入组 75 人开始时间: 2025年1月10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
75
试验地点
2
主要终点
Visual Analog Scale (VAS)

研究概览

简要总结

The study aimed to examine the effects of two different applications (stress ball and 4-7-8 breathing technique) before Upper GI Endoscopy on patients' fear, anxiety and physiological parameters before the procedure.

The study as a single-blind, pre-test and post-test experimental study.

详细描述

Due to the procedures involved, endoscopy patients experience high levels of fear and anxiety. Fear and anxiety may activate the patient's autonomic nervous system, causing increased sweating, heart rate, blood pressure and respiratory rate, and complications related to the procedure. Reducing fear and anxiety and making the patient feel relaxed not only prevents possible harm to the patient due to the procedure, but also facilitates the work of the healthcare team performing the procedure and ensures accurate results. In this context, this study aimed to examine the effects of stress ball exercise and 4-7-8 breathing technique on the fear, anxiety and vital signs of patients who will undergo Upper Gastrointestinal (GI) endoscopy.

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 (Outcomes Assessor)

入排标准

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

入选标准

  • Upper GI Endoscopy will be performed for the first time,
  • American Society of Anesthesiologists (ASA) Status I-II
  • Those over 18 years of age
  • Participates in the research voluntarily and is willing to cooperate.
  • No visual impairment, hearing impairment or communication problem,
  • Not having a psychiatric diagnosis and not using anxiolytic, hypnotic or sedative drugs

排除标准

  • Those diagnosed with severe respiratory failure
  • Those who have health problems in the hand, wrist or arm area that prevent squeezing the stress ball.
  • Using psychiatric medication (antipsychotic, antidepressant, anxiolytic, sedative, etc.
  • Anyone who wishes to leave the research at any stage of the research, with his or her own initiative.

研究组 & 干预措施

Control group

No Intervention

The group in which no intervention was performed before endoscopy and routine care was given

stress ball

Experimental

group applying the stress ball for 20 minute before endoscopy

干预措施: stress ball (Other)

4-7-8 breathing technique

Experimental

group applying the 4-7-8 breathing technique for 6 sets before endoscopy

干预措施: 4-7-8 breathing technique (Other)

结局指标

主要结局

Visual Analog Scale (VAS)

时间窗: At the beginning and end of the 20-minute stress ball or breathing exercise intervention (before the endoscopy procedure)

Developed by Price et al. (1983), VAS is a reliable, valid and practical measurement tool for repeated measurements. The scale, which is generally used to score pain, will be used in this study to score patients' fear between 1-10 points. The scale is represented by a 10 cm line representing the lowest and highest scores for fear (0 = no fear, 10 = most intense fear).

State-Trait Anxiety İnventory

时间窗: At the beginning and end of the 20-minute stress ball or breathing exercise intervention (before the endoscopy procedure)

It was developed by Spielberger and his colleagues in 1970. It has two parts: State and Trait Anxiety. The State Anxiety Scale section determines how a person feels at a particular moment and under certain conditions. The feelings or behaviors expressed by the person are answered by marking one of the options: (1) not at all, (2) a little, (3) a lot, (4) completely, depending on the degree of severity. Trait Anxiety Scale is related to how the individual feels in general, regardless of the current situation.

次要结局

  • systolic blood pressure (mm/Hg)(At the beginning and end of the 20-minute stress ball or breathing exercise intervention (before the endoscopy procedure))
  • diastolic blood pressure (mm/Hg)(At the beginning and end of the 20-minute stress ball or breathing exercise intervention (before the endoscopy procedure))
  • SpO2-peripheral oxygen saturation (%)(At the beginning and end of the 20-minute stress ball or breathing exercise intervention (before the endoscopy procedure))
  • Respiratory rate (minute value)(At the beginning and end of the 20-minute stress ball or breathing exercise intervention (before the endoscopy procedure))
  • heart rate (minute value)(At the beginning and end of the 20-minute stress ball or breathing exercise intervention (before the endoscopy procedure))

研究者

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

Ayse Gul Parlak

Assistant professor

Kafkas University

研究点 (2)

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