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Completed

NCT Number: NCT06635941

Predictive Model Identifies Painful Sedation-free Colonoscopy

Colorectal cancer is one of the most common cancers globally and a leading cause of cancer-related death. Colonoscopy is the standard screening method for colorectal cancer, significantly reducing mortality rates. However, the pain experienced during the procedure is one of the main reasons people avoid getting a colonoscopy. If operators can identify patients who are more likely to feel pain before the procedure, operators can take steps to reduce their discomfort. Previous research has developed a model to predict discomfort during colonoscopy, but this model have some limitations in clinical use. Therefore, investigators plan to develop a new model that also predicts the likelihood of painful colonoscopies.

This study aims to identify factors related to pain in non-sedated colonoscopy and create a more accurate prediction model to help reduce pain during the procedure.

A total of 679 patients will be divided into two groups randomly for training and validation. Participants meet the inclusion criteria for this study, and investigators will ask participants to participate voluntarily. If participants agree, investigators will collect some of participants basic information and medical history, and assess participants' pain during the procedure.

Participants will only need to follow the doctors' instructions, complete bowel investigators' preparation, and undergo the colonoscopy as usual. The data collection will not interfere with participants' regular care

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Key information

Conditions

Pain Colonoscopy Neurologic Manifestations Non-sedated Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

the First Affiliated Hospital of Ningbo University, Ningbo

Ningbo, Zhejiang, 315000, China

Who can participate

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

Inclusion criteria

  • Patients undergoing non-sedated colonoscopy at Ningbo University Affiliated Hospital from September 2024 to September 2025.
  • Age: Patients aged 18 to 75 years.
  • Voluntary participation: Patients who voluntarily agree to participate in the study and have signed the informed consent form.

Exclusion criteria

  • Patients under 18 years old.
  • Patients who are unwilling or unable to provide informed consent.
  • Patients with malignant diseases, severe chronic heart or lung diseases, or those who have received treatment or radiation therapy for coronary artery or cerebrovascular events requiring hospitalization in the past 3 months.
  • Patients with a history of colorectal resection or those with an incomplete colon.
  • Patients who do not require reaching the ileocecal valve.
  • Patients who have not completed bowel preparation or who have only used enemas for bowel cleaning.
  • Patients with severe bowel obstruction or bowel perforation.
  • Pregnant or breastfeeding women. -

Treatment and study plan

Primary outcomes

  1. colonoscopy-related pain

    Time frame: during the intubation procedure of sedated-free colonoscopy

    The primary outcome is the the pain during the procedure of sedated-free colonoscopy according to a 4-point verbal rating scale (VRS-4), which is a four-category lanuage scale that classifies pain as no(0), slight(1), moderate(2), and se vere(3).

Sponsors and collaborators

Lead sponsor

Ningbo No. 1 Hospital

Other

Registry information

Official study title

A Predictive Model Identifies Patients Likely To Be Painful During Sedation-free Colonoscopy.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 10, 2024
Registry last updated
Nov 24, 2025

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.

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