PainNCT06635941
Predictive Model Identifies Painful Sedation-free Colonoscopy
An observational study of Pain and Non-sedated, run by Ningbo No. 1 Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain, Non-sedated, Colonoscopy
- How many people
- 679 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2024to 21 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: the people who is about to have a sedation-free colonoscopy
Who may be able to join
- 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.
Who cannot join
- 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. -
Trial locations and contacts
1 site in 1 country.
China1 site
the First Affiliated Hospital of Ningbo University, Ningbo
Ningbo, Zhejiang, 315000
About this study
Official title: A Predictive Model Identifies Patients Likely To Be Painful During 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.
Read more
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
- Conditions
- Pain, Non-sedated, Colonoscopy
- Medical subject headings
- Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
colonoscopy-related pain
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).
Measured: during the intubation procedure of sedated-free colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start10 Oct 2024
- Primary completion21 Sep 2025
- Study completion21 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 679 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ningbo No. 1 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06635941
- Sponsor's protocol ID
- 2024-110A-01
- Status last verified
- Sep 2025
- First submitted
- 22 Sep 2024
- Last updated
- 24 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Predictive Model Identifies Patients Likely To Be Painful During Sedation-free Colonoscopy.
- ClinicalTrials.gov ID
- NCT06635941
- Acronym / sponsor ID
- 2024-110A-01
- Conditions
- Pain, Non-sedated, Colonoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 679 participants (actual)
- Lead sponsor
- Ningbo No. 1 HospitalUniversity, hospital or other
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 21 Sep 2025 (actual)
- Study completion
- 21 Sep 2025 (actual)
- First posted
- 10 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- the people who is about to have a sedation-free colonoscopy
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Non-sedated, run by Ningbo No. 1 Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
colonoscopy-related pain (time frame: during the intubation procedure of sedated-free colonoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.