Verbal Suggestion to Reduce Pain and Anxiety During Unsedated Colonoscopy
Improving Patient Comfort Without Sedation: The Impact of Verbal Suggestion on Anxiety and Pain During Colonoscopy
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Yenimahalle
-
Ankara, Yenimahalle, Turkey (Türkiye), 06500
- Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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. |
|
No Intervention: Control Group
Patients undergoing unsedated colonoscopy will receive standard communication without verbal suggestion during the procedure. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in anxiety level before and after colonoscopy
Time Frame: 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
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart rate during colonoscopy
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-03/54
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.