Analysis of the Analgesic Mechanism of TENS-WAA During Non-anesthetized Colonoscopy Using EEG-fNIRS System
NCT06813703
Colonoscopy, Neurologic Manifestations
Shanghai, Shanghai Municipality, China
View Trial DetailsNCT Number: NCT07353632
This prospective observational study investigates how participants experience screening colonoscopy within the Danish colorectal cancer screening program and how these experiences relate to clinical findings, procedural factors, and future participation in screening.
The study aims to evaluate patient-reported experiences such as pain, discomfort, preparation burden, emotional responses, and perceptions of healthcare staff, as well as staff-assessed pain during the procedure. These experiences will be examined in relation to colonoscopy findings, including polyp detection, histology, risk stratification, and colorectal cancer detection. In addition, procedure-specific variables such as insertion time, bowel preparation quality, completeness of colonoscopy, medication use, and adenoma detection rate will be analyzed in relation to patient experience.
A key focus is whether the experience of screening colonoscopy influences subsequent participation in the colorectal cancer screening program, particularly among individuals classified as low risk and re-invited for screening after two years. Registry-based follow-up will be used to assess re-participation.
Data are collected prospectively from two sources: (1) real-time procedure data entered by healthcare staff during colonoscopy and (2) patient-reported outcomes collected via a questionnaire completed shortly after the procedure. Additional outcome data are obtained from electronic medical records and national health and screening registries.
The study has no single predefined hypothesis. Instead, it serves as a data-generating platform designed to address both predefined and future research questions related to screening colonoscopy experiences, quality indicators, and screening adherence.
Interested in participating?
Request Info50 year–75 year
All sexes
Observational
Sygehus Sønderjylland, University hospital of Southern Denmark, Aabenraa, Denmark
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: apr. 15min after colonoscopy
11-point numerical rating scale ranging from 0 (least pain) to 10(most pain)
Time frame: 2 years following colonoscopy
2-year Re-participation rate for those calssified as low risk after index colonoscopy
Contact information is provided by the study sponsor or research team.
Anitta Øhlenschlæger, Research secretary
CONTACT
Magnus Ploug, phd
CONTACT
Esbjerg Hospital - University Hospital of Southern Denmark
Other
Re-participation for Screening-colonoscopy - Experience of colonoscpy_1
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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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