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临床试验/NCT07261839
NCT07261839Enrolling By Invitation不适用

Effect of Visualized Meditation on Anxiety, Pain, and Comfort in Patients Undergoing Endoscopy

University of Gaziantep1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2025年7月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
72
试验地点
1
主要终点
VAS Pain and Comfort Scale

研究概览

简要总结

Endoscopy is one of the most frequently performed procedures for the early diagnosis and treatment of many diseases and plays a crucial role in the diagnosis and treatment of upper gastrointestinal disorders. Sometimes, endoscopy may be the only option for detecting certain diseases of the stomach and larynx. However, for many patients, endoscopy is considered an invasive, highly painful, and extremely uncomfortable procedure. Furthermore, anxiety and fear felt before the procedure can cause physical and emotional discomfort, disrupt patient comfort, and cause pain.

详细描述

Endoscopy is one of the most frequently performed procedures for the early diagnosis and treatment of various gastrointestinal disorders and plays a critical role, particularly in the evaluation of upper gastrointestinal system pathologies. In certain clinical situations, endoscopy may be the only reliable method for identifying diseases occurring in the stomach, esophagus, and larynx. Despite its diagnostic and therapeutic value, endoscopy is commonly perceived by patients as an invasive, uncomfortable, and often painful procedure. In addition, the anxiety and fear experienced before the procedure can lead to both physical and emotional distress, negatively affecting overall patient comfort and potentially intensifying the perception of pain.

Moderate to severe anxiety during endoscopy has been shown to increase the likelihood of procedural difficulties, prolong the duration of the examination, reduce patient satisfaction, and elevate the risk of complications. These adverse effects highlight the importance of implementing non-pharmacological strategies aimed at reducing anxiety and improving patient comfort. One such approach-guided visualization or visualized meditation-has gained attention as a simple, cost-effective, and patient-friendly method that promotes relaxation, reduces emotional tension, and supports pain management.

Considering the potential of guided visualization to enhance tolerance to the procedure and improve patient experiences, researchers were motivated to explore its effectiveness in this specific population. Therefore, this study was designed to determine the effect of visualized meditation applied to patients undergoing endoscopy on their levels of anxiety, pain, and comfort.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

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

入选标准

  • •Patients over the age of 18, with no hearing impairment,
  • •Students undergoing endoscopy for the first time,
  • •Not diagnosed with a psychiatric disorder and therefore not on medication,
  • •Willing to participate in the study

排除标准

  • •Patients who refused to participate in the study, underwent endoscopy for biopsy, or received deep sedation.
  • •Patients who volunteered to participate and then wished to withdraw from the study at any stage.

研究组 & 干预措施

Visualized meditation group

Active Comparator

Visualized meditation for patients who have had an endoscopy

干预措施: Visualized meditation (Other)

Control group

No Intervention

Control group

结局指标

主要结局

VAS Pain and Comfort Scale

时间窗: From enrollment to the end of treatment at 4 months

This scale was developed by Price and colleagues (1983). It is used to measure subjective pain and comfort levels. The scale is represented by a 10-cm line representing the lowest and highest pain scores (0: no pain/discomfort, 10: most intolerable pain/discomfort).

The State Trait Anxiety Inventory (STAI)

时间窗: "From enrollment to the end of treatment at 4 months

The State Trait Anxiety Inventory (STAI), developed by Spielberger et al. in 1964, will be used to measure anxiety in this study. The scale has two dimensions: the STAI-S, which measures state anxiety, and the STAI-T, which measures trait anxiety. The STAI-S and STAI-T each consist of 20 items. Items 1-40 on the scale measure anxiety in four ways. The lowest score for both dimensions of the scale is 20, and the highest score is 80. As the score increases, the level of anxiety also increases.

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

Tuğba Albayram

Research Assistant Dr

University of Gaziantep

研究点 (1)

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