Ignite Creation Date:
2024-05-06 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06233253
Status:
RECRUITING
Last Update Posted:
2024-01-31
First Post:
2024-01-08
Brief Title:
Online Mindfulness-Based Intervention to Decrease Pre-Procedural Anxiety Before a First-Time Screening Colonoscopy
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
Ohio State University Comprehensive Cancer Center
Study Overview
Official Title:
A Brief Online Mindfulness-Based Intervention to Decrease Pre-Procedural Anxiety Before a First-Time Screening Colonoscopy A Pilot Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2023-10496 | REGISTRY | CTRP Clinical Trial Reporting Program | None |