Anxiety, Colonoscopy, Pain, Patient Comfort, Sedation-Free Procedure
Conditions
Brief summary
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.
Interventions
BEHAVIORALVerbal Suggestion
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.
Sponsors
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain score during colonoscopy | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate change during the procedure | During colonoscopy | Heart rate will be monitored continuously during colonoscopy. The maximum heart rate recorded during the procedure will be used as an objective physiologic measure. |
| Anxiety level before and after colonoscopy | within 30 minutes before and after procedure | ty will be assessed using the Beck Anxiety Inventory (BAI; 0-63, higher scores indicate greater anxiety). Pre- and post-procedure scores will be compared. |
Countries
Turkey (Türkiye)
Outcome results
None listed