NCT06233253

Online Mindfulness-Based Intervention to Decrease Pre-Procedural Anxiety Before a First-Time Screening Colonoscopy

A Brief Online Mindfulness-Based Intervention to Decrease Pre-Procedural Anxiety Before a First-Time Screening Colonoscopy: A Pilot Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Colorectal Carcinoma

Interventions

Type	Name	Description
OTHER	Best Practice	Receive usual care
OTHER	Medical Chart Review	Ancillary studies
BEHAVIORAL	Online Mindfulness Meditation	Receive an online mindfulness intervention
OTHER	Survey Administration	Ancillary studies

Timeline

• Start date: 2023-09-29
• Primary completion: 2024-07-12
• Completion: 2024-07-12
• First posted: 2024-01-31
• Last updated: 2025-02-24

Locations

1 site across 1 country: United States