Brief Mindfulness Intervention for Patients at a Free Acute Care Clinic

Not Applicable

Recruiting

• Conditions: Pain

• Registration Number: NCT07025161
• Lead Sponsor: Florida State University

Brief Summary

This is a single-site, two-arm, parallel-group randomized clinical trial (RCT). The clinical effects of a 4-minute audio-recorded mindfulness intervention for 100 English-speaking patients and 100 Spanish-speaking patients at a free acute care clinic will be investigated relative to a 4-minute audio-recoding about pain psychoeducation.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-04-21
• Study First Submitted: 2025-04-23
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-16
• Last Update Submitted: 2025-06-16
• Study First Posted: 2025-06-17
• Last Update Posted: 2025-06-17
• Primary Completion: 2026-04-21
• Study Completion: 2026-04-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Age ≥18
• Seeking treatment at the Shepherd's Hope Downtown Clinic

Exclusion Criteria

• Cognitive impairment preventing completion of study procedures.
• Other unstable illness judged by medical staff to interfere with study involvement.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Pain Unpleasantness Numeric Rating Scale	Immediately before to after 4-minute audio recording	Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most unpleasant pain imaginable.

Secondary Outcome Measures

Name	Time	Method
Change in Pain Intensity Numeric Rating Scale	Immediately before to after 4-minute audio recording	Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most intense pain imaginable.
Change in Anxiety Numeric Rating Scale	Immediately before to after 4-minute audio recording	Single Likert scale item ranging from 0-10, with 0 indicating no anxiety and 10 representing severe anxiety.

Trial Locations

Locations (1)

Shepherd's Hope Downtown Clinic; 🇺🇸 Orlando, Florida, United States