减轻无镇静结肠镜检查期间疼痛和焦虑的口头建议
无镇静状态下提升患者舒适度：言语暗示对结肠镜检查期间焦虑与疼痛的影响
Colonoscopy is an important diagnostic and screening procedure for colorectal diseases, but it can cause pain and anxiety, especially when performed without sedation. Verbal suggestion techniques - in which the physician provides calm, positive, and encouraging communication during the procedure - may help reduce these unpleasant experiences.
This randomized controlled study aims to evaluate the effect of verbal suggestion on pain and anxiety levels of patients undergoing unsedated colonoscopy. Sixty adult patients will be randomly assigned to either a verbal suggestion group or a control group. In the verbal suggestion group, the endoscopist will use positive and supportive phrases during the procedure (for example: "You are doing great," "Take a deep breath, we'll get through this easily"). The control group will undergo colonoscopy without any verbal intervention.
Pain will be assessed using a Visual Analog Scale (VAS) and anxiety will be measured with the Beck Anxiety Inventory (BAI) before and after the procedure. Heart rate will also be monitored as an objective indicator of anxiety.
The goal of this study is to determine whether verbal suggestion can improve patient comfort and tolerance during colonoscopy without sedation, potentially providing a low-cost and practical method to enhance patient experience.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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-
Yenimahalle
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Ankara、Yenimahalle、土耳其（türkiye）、06500
- Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Adults aged 18 to 70 years.
- Patients scheduled for elective, diagnostic, or screening colonoscopy without sedation.
- Ability to understand and provide written informed consent.
- Ability to communicate verbally with the endoscopist during the procedure.
- ASA (American Society of Anesthesiologists) physical status classification I-II.
Exclusion Criteria:
- Refusal or inability to provide informed consent.
- Known psychiatric or neurological disorders that could affect anxiety or pain perception.
- Use of anxiolytic, sedative, or analgesic drugs within 24 hours before the procedure.
- Colonoscopy performed under sedation or anesthesia.
- Severe cardiopulmonary comorbidities (ASA class ≥ III).
- Incomplete colonoscopy due to technical or anatomical reasons.
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Verbal Suggestion Group
Patients undergoing unsedated colonoscopy will receive positive verbal suggestion from the endoscopist throughout the procedure (e.g., "You are doing great," "Take a deep breath," "It will be over soon.") |
During unsedated colonoscopy, the endoscopist will use positive verbal suggestions aimed at reducing patients' anxiety and perceived pain. The phrases include encouraging and calming statements such as "You are doing well," "Take a deep breath," and "We're almost done." The communication is supportive, consistent, and non-directive throughout the procedure. |
|
无干预：Control Group
Patients undergoing unsedated colonoscopy will receive standard communication without verbal suggestion during the procedure. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in anxiety level before and after colonoscopy
大体时间：Immediately before and within 10 minutes after the procedure
|
Anxiety will be assessed using the Beck Anxiety Inventory (BAI). BAI scores will be obtained immediately before the procedure and within 10 minutes after completion of the colonoscopy. Higher scores indicate greater anxiety. |
Immediately before and within 10 minutes after the procedure
|
|
Pain intensity during colonoscopy
大体时间：During colonoscopy
|
Pain intensity will be assessed using an 11-point Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst possible pain). Pain scores will be recorded at 5 minutes after the start of the procedure and at 10-minute intervals thereafter during colonoscopy. |
During colonoscopy
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Heart rate during colonoscopy
大体时间：Before and during colonoscopy
|
Heart rate was recorded immediately before the procedure, at 5 minutes after the start of colonoscopy, and at 10-minute intervals thereafter during the procedure. |
Before and during colonoscopy
|
|
Oxygen saturation (SpO₂) during colonoscopy
大体时间：Before and during colonoscopy
|
Peripheral oxygen saturation (SpO₂) was recorded immediately before the procedure, at 5 minutes after the start of colonoscopy, and at 10-minute intervals thereafter during the procedure. |
Before and during colonoscopy
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.