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Verbal Suggestion to Reduce Pain and Anxiety During Unsedated Colonoscopy

D

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Status

Completed

Conditions

Patient Comfort
Colonoscopy
Anxiety
Pain
Sedation-Free Procedure

Treatments

Behavioral: Verbal Suggestion

Study type

Interventional

Funder types

Other

Identifiers

NCT07228884
2025-03/54

Details and patient eligibility

About

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.

Enrollment

102 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

102 participants in 2 patient groups

Verbal Suggestion Group
Experimental group
Description:
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.")
Treatment:
Behavioral: Verbal Suggestion
Control Group
No Intervention group
Description:
Patients undergoing unsedated colonoscopy will receive standard communication without verbal suggestion during the procedure.

Trial contacts and locations

1

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Central trial contact

Yasemin Keskin, Medical Doctor

Data sourced from clinicaltrials.gov

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