Improving Patient Comfort Without Sedation: The Impact of Verbal Suggestion on Anxiety and Pain During Colonoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Pain score during colonoscopy
研究概览
简要总结
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
- 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
- •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.
排除标准
- •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.
研究组 & 干预措施
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.")
干预措施: Verbal Suggestion (Behavioral)
Control Group
Patients undergoing unsedated colonoscopy will receive standard communication without verbal suggestion during the procedure.
结局指标
主要结局
Pain score during colonoscopy
时间窗: immediately after procedure
Pain intensity will be measured using the Visual Analog Scale (VAS; 0-10, higher scores indicate worse pain). The score will be recorded immediately after the procedure.
次要结局
- Heart rate change during the procedure(During colonoscopy)
- Anxiety level before and after colonoscopy(within 30 minutes before and after procedure)
研究者
Yasemin Keskin
Specialist in General Surgery
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital