Real-time notifications during colonoscopy to reduce patient anxiety and depression
Impact of Real-time Notification of Colonoscopic Optical Diagnosis on Patients' Anxiety and Depression After Polypectomy: a Randomized Control Trial
This study is testing if giving patients real-time updates about their colorectal polyps during a colonoscopy can help reduce their anxiety and depression after the procedure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 40 Years to 79 Years |
| Sex | All |
| Sponsor | Fu Jen Catholic University Academic / other |
| Locations | 1 site (New Taipei City) |
| Trial ID | NCT05517343 on ClinicalTrials.gov |
What this trial studies
This study investigates the effect of real-time notifications regarding the nature of colorectal polyps on patients' anxiety and depression levels after polypectomy. It is a single-center, open-label, prospective, and parallel randomized controlled trial involving outpatients aged 40 to 79 scheduled for sedated colonoscopy. Participants diagnosed with colorectal polyps will be randomly assigned to either receive immediate feedback about their diagnosis or standard care, with their anxiety and depression levels measured before their next clinic visit for histological results. The goal is to determine if real-time notifications can improve post-polypectomy care and enhance patients' quality of life.
Who should consider this trial
Good fit: Ideal candidates are outpatients aged 40 to 79 who are scheduled for sedated colonoscopy and are expected to undergo polypectomy.
Not a fit: Patients with major mental illnesses or contraindications to colonoscopy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce anxiety and depression in patients undergoing polypectomy.
How similar studies have performed: While similar studies have explored patient anxiety in medical procedures, this specific approach of real-time notifications is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age of ≥ 40 years and \< 80 years * Outpatients who prepare receiving sedated colonoscopy * Subjects who have signed informed consent form of this study * Informed consensus has been obtained that endoscopic resection should be performed if a colorectal polyp is found * Eastern Cooperative Oncology Group (ECOG) performance status scale among 0 to 2 Exclusion Criteria: * Subjects with any of the following prior history or current conditions: * (a) Contraindications to colonoscopy * (b) Major mental illnesses, e.g. major depressive disorder, schizophrenia, generalized anxiety disorder ... * (c) Inflammatory bowel disease * (d) Hereditary or non-hereditary polyposis syndrome, hereditary non-polyposis colorectal cancer * (e) Uncured colorectal cancer * (f) Active gastrointestinal bleeding * (g) Pregnancy * Subjects who do not received polypectomy during colonoscopy.
Where this trial is running
New Taipei City
- Fu Jen Catholic University Hospital — New Taipei City, Taiwan (Recruiting)
Study contacts
- Study coordinator: Chen-Ya Kuo, bachelor
- Email: b9402039@gmail.com
- Phone: +886975701515
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.