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: Completed
• Conditions: Pain; Anxiety; Colonoscopy; Patient Comfort; Sedation-Free Procedure
• Intervention / Treatment: Behavioral: Verbal Suggestion

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Yenimahalle
    • Ankara, Yenimahalle, Turkey (Türkiye), 06500
      • Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

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)

Number of Arms

2

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.")	Behavioral: Verbal 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.
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
Pain score during colonoscopy	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.	immediately after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate change during the procedure	Heart rate will be monitored continuously during colonoscopy. The maximum heart rate recorded during the procedure will be used as an objective physiologic measure.	During colonoscopy
Anxiety level before and after colonoscopy	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.	within 30 minutes before and after procedure

Collaborators and Investigators

• Sponsor: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2025
• Primary Completion (Actual): December 30, 2025
• Study Completion (Actual): December 30, 2025

Study Registration Dates

• First Submitted: November 13, 2025
• First Submitted That Met QC Criteria: November 13, 2025
• First Posted (Estimated): November 14, 2025

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Mental Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Anxiety Disorders
• Other Study ID Numbers: 2025-03/54

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No