Mental Stress and Bowel Preparation Quality | NCT06007313

Studies
Mental Stress and Bowel Preparation Quality

NCT06007313

Sponsor

RenJi Hospital

Status

Unknown status

Last Update Posted

Aug 23, 2023Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Colonoscopy
Intestinal Disease

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2023Actual

Primary Completion Date

Aug 30, 2023Estimated

Completion Date

Aug 30, 2023Estimated

First Submitted Date

Aug 7, 2023

First Submission Date that Met QC Criteria

Aug 17, 2023

First Posted Date

Aug 23, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 17, 2023

Last Update Posted Date

Aug 23, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	During colonoscopy, about 20 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Withdrawal prior to colonoscopy
Incomplete completion of information

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Patients who underwent colonoscopy from May 2023-August 2023 at the Endoscopy Centre, Renji East Hospital.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wen-yu Su, Ph.D.	Contact	00-86-021-13761981114		swy260589@126.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Renji Hospital, School of Medicine, Shanghai Jiao Tong University	Recruiting	Shanghai	Shanghai Municipality	200127	China

Condition Browse Module

MeSH Terms

ID	Term
D007410	Intestinal Diseases

Ancestor Terms

ID	Term
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

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Browse Branches

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