Verbal Suggestion to Reduce Pain and Anxiety During Unsedated Colonoscopy

NCT07228884 | Completed

• 1 other identifier: 2025-03/54
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Pain; Colonoscopy; Sedation-Free Procedure; Patient Comfort

Outcome Measures

Primary Outcomes (2)

• Change in anxiety level before and after colonoscopy

  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

  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 Outcomes (2)

• Heart rate during colonoscopy

  Before and during colonoscopy

• Oxygen saturation (SpO₂) during colonoscopy

  Before and during colonoscopy

Study Arms (2)

Verbal Suggestion Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

Patients undergoing unsedated colonoscopy will receive standard communication without verbal suggestion during the procedure.

Interventions

Verbal Suggestion BEHAVIORAL

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.

Verbal Suggestion Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Ankara, Yenimahalle, 06500, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist in General Surgery

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 14, 2025
• Study Start: April 30, 2025
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: September 30, 2026

Record last verified: 2025-10

Locations

TU (1)