ColonoscopyNCT06007313
Mental Stress and Bowel Preparation Quality
An observational study of Colonoscopy and Intestinal Disease, run by RenJi Hospital at 1 site in China.
Trial summary
The goal of this cross-sectional study was to explore the relationship between physical and psychological stress and the quality of bowel preparation before a colonoscopy examination, in order to improve the quality of bowel preparation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colonoscopy, Intestinal Disease
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 30 Aug 2023
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent colonoscopy from May 2023-August 2023 at the Endoscopy Centre, Renji East Hospital.
Who may be able to join
- Participants aged 18 to 75 years old with an indication for colonoscopy
- Participants signed an informed consent form for colonoscopy and underwent colonoscopy
- Participants not be with a history of digestive tumors, active inflammatory bowel disease and other conditions that significantly affect colonic motility
- Participants with good communication and comprehension skills and be able to answer assessment questions accurately
Who cannot join
- Withdrawal prior to colonoscopy
- Incomplete completion of information
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200127
Wen-yu Su, Ph.D., 00-86-021-13761981114, swy260589@126.com
About this study
Official title: A Cross-sectional Study of the Relationship Between Mental Stress and Bowel Preparation
The goal of this cross-sectional study was to explore the relationship between physical and psychological stress and the quality of bowel preparation before a colonoscopy examination, in order to improve the quality of bowel preparation.
The main questions it aims to answer are:
Does physical and psychological stress affect the quality of colonoscopic bowel preparation, and delay disease detection? How can we improve the quality of colonoscopy？ Participants will be asked to complete a questionnaire containing their demographics, history of diseases and drugs, lifestyle habits, and physical and 14-item perceived stress scale(PSS-14). Quality of bowel preparation was assessed by the Boston bowel preparation scale（BPS）.
Read the detailed description
A total of 1000 patients who were to undergo colonoscopy at the Endoscopy Centre of the Department of Gastroenterology, Renji Hospital, from May 2023 to August 2023 were collected, and the general information and the physical and mental stress test scale of the patients were collected by questionnaires from random samples, and they were screened for enrolment according to the inclusion and exclusion criteria. The correlation between physical and mental stress and the quality of bowel preparation for colonoscopy was analyzed according to the Boston Rating Scale (BPS), which is used by colonoscopists to assess the quality of bowel preparation for each patient.
- Conditions
- Colonoscopy, Intestinal Disease
- Medical subject headings
- Intestinal Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
The quality of bowel preparation
Quality of bowel preparation was assessed by the Boston bowel preparation scale(BPS). The BPS is used to assess the quality of bowel preparation on a 9-point scale. The colon is divided into three sections (right-sided colon, transverse colon and left-sided colon) and each segment is scored on a four-point scale (0-3), with higher scores indicating a cleaner bowel. The total Boston score is 9, with a score of less than 6 indicating poor bowel preparation.
Measured: During colonoscopy, about 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start1 May 2023
- Primary completion30 Aug 2023 (estimated)
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06007313
- Sponsor's protocol ID
- swyclinical2023
- Status last verified
- Aug 2023
- First submitted
- 7 Aug 2023
- Last updated
- 23 Aug 2023
- 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 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional Study of the Relationship Between Mental Stress and Bowel Preparation
- ClinicalTrials.gov ID
- NCT06007313
- Acronym / sponsor ID
- swyclinical2023
- Conditions
- Colonoscopy, Intestinal Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Aug 2023 (estimated)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 23 Aug 2023 (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.
The goal of this cross-sectional study was to explore the relationship between physical and psychological stress and the quality of bowel preparation before a colonoscopy examination, in order to improve the quality of bowel preparation.
The main questions it aims to answer are:
Does physical and psychological stress affect the quality of colonoscopic bowel preparation, and delay disease detection? How can we improve the quality of colonoscopy？ Participants will be asked to complete a questionnaire containing their demographics, history of diseases and drugs, lifestyle habits, and physical and 14-item perceived stress scale(PSS-14). Quality of bowel preparation was assessed by the Boston bowel preparation scale（BPS）.
Detailed description
A total of 1000 patients who were to undergo colonoscopy at the Endoscopy Centre of the Department of Gastroenterology, Renji Hospital, from May 2023 to August 2023 were collected, and the general information and the physical and mental stress test scale of the patients were collected by questionnaires from random samples, and they were screened for enrolment according to the inclusion and exclusion criteria. The correlation between physical and mental stress and the quality of bowel preparation for colonoscopy was analyzed according to the Boston Rating Scale (BPS), which is used by colonoscopists to assess the quality of bowel preparation for each patient.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent colonoscopy from May 2023-August 2023 at the Endoscopy Centre, Renji East Hospital.
Key inclusion criteria (4 listed)
- Participants aged 18 to 75 years old with an indication for colonoscopy
- Participants signed an informed consent form for colonoscopy and underwent colonoscopy
- Participants not be with a history of digestive tumors, active inflammatory bowel disease and other conditions that significantly affect colonic motility
- Participants with good communication and comprehension skills and be able to answer assessment questions accurately
Key exclusion criteria (2 listed)
- Withdrawal prior to colonoscopy
- Incomplete completion of information
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
The quality of bowel preparation
Time frame: During colonoscopy, about 20 minutes
Quality of bowel preparation was assessed by the Boston bowel preparation scale(BPS). The BPS is used to assess the quality of bowel preparation on a 9-point scale. The colon is divided into three sections (right-sided colon, transverse colon and left-sided colon) and each segment is scored on a four-point scale (0-3), with higher scores indicating a cleaner bowel. The total Boston score is 9, with a score of less than 6 indicating poor bowel preparation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
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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.
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 Colonoscopy and Intestinal Disease, run by RenJi 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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 23 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wen-yu Su, Ph.D. (00-86-021-13761981114, swy260589@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The quality of bowel preparation (time frame: During colonoscopy, about 20 minutes). 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 23 Aug 2023.