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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain score during colonoscopy
Timeframe: immediately after procedure
Trial details
NCT IDNCT07228884
SponsorDr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital