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Clinical Trial Summary

This clinical trial tests how well an online mindfulness-based intervention (MBI) works to decrease anxiety in patients before a first-time screening colonoscopy. Elevated pre-procedural anxiety can affect patient outcomes including bowel preparation adherence and quality, the amount of sedation required, procedure time, patient satisfaction, cancellation or no-shows, and intention for future cancer screening. Mindfulness is a form of meditation that focuses on staying within the present moment to reduce anxiety. Previous research supports mindfulness practice among cancer survivors to decrease anxiety, fear of cancer re-occurrence, and to improve quality of life. Online MBIs have the potential to include targeted meditations and educational information designed to promote behavior change. This study may help researchers learn whether a mindfulness intervention works to decrease anxiety in patients before a first-time screening colonoscopy.


Clinical Trial Description

PRIMARY OBJECTIVE: I. To establish intervention feasibility and acceptability, and to collect preliminary efficacy data on a developed online mindfulness-based intervention (MBI) to reduce pre-procedural anxiety before a first-time screening colonoscopy compared to usual care. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients receive usual care prior to their scheduled screening colonoscopy. GROUP II: Patients receive an online mindfulness intervention including infographics and 5-minute meditations once daily (QD) for 5 days prior to their scheduled screening colonoscopy. After completion of study intervention, patients are followed up 1-2 days post-colonoscopy. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06233253
Study type Interventional
Source Ohio State University Comprehensive Cancer Center
Contact
Status Recruiting
Phase N/A
Start date September 29, 2023
Completion date December 31, 2024

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