Skip to main content
OpenTrials
Completed

NCT Number: NCT07228884

Verbal Suggestion to Reduce Pain and Anxiety During Unsedated 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anxiety Anxiety Disorders Colonoscopy Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Patient Comfort Sedation-Free Procedure Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Ankara, Yenimahalle, 06500, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Pain score during colonoscopy

    Time frame: 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 outcomes

  1. Heart rate change during the procedure

    Time frame: 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.

  2. Anxiety level before and after colonoscopy

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Other

Registry information

Official study title

Improving Patient Comfort Without Sedation: The Impact of Verbal Suggestion on Anxiety and Pain During Colonoscopy

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 14, 2025
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.