Verbal Suggestion to Reduce Pain and Anxiety During Unsedated Colonoscopy

NCT ID: NCT07228884

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-30
• Study Completion Date: 2025-12-30

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; Patient Comfort; Sedation-Free Procedure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.")

Group Type: EXPERIMENTAL

Verbal Suggestion

Intervention Type: 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.

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yasemin Keskin

Specialist in General Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Ankara, Yenimahalle, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2025-03/54

Identifier Type: -

Identifier Source: org_study_id