Brief Mindfulness Intervention for Patients at a Free Acute Care Clinic

NCT07025161 | Recruiting

• 1 other identifier: STUDY00004916 Shepherd's Hope
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Change in Pain Unpleasantness Numeric Rating Scale

  Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most unpleasant pain imaginable.

  Immediately before to after 4-minute audio recording

Secondary Outcomes (2)

• Change in Pain Intensity Numeric Rating Scale

  Immediately before to after 4-minute audio recording

• Change in Anxiety Numeric Rating Scale

  Immediately before to after 4-minute audio recording

Study Arms (2)

Pain Coping Information

ACTIVE COMPARATOR

Participants will be randomized to listen to a 4-minute audio recording providing common pain coping techniques (e.g., ice, rest, medication, surgery).

Behavioral: Pain Coping Information

Mindful Pain Management

EXPERIMENTAL

Participants will be randomized to listen to a 4-minute audio recording consisting of a 1-minute introduction to mindfulness followed by a 1-minute and 30-second mindful breathing practice and a 1-minute and 30-second mindfulness of pain practice.

Behavioral: Mindful Pain Management

Interventions

Pain Coping Information BEHAVIORAL

A 4-minute audio recording providing common pain coping techniques (e.g., ice, rest, medication, surgery).

Pain Coping Information

Mindful Pain Management BEHAVIORAL

A 4-minute audio recording consisting of a 1-minute introduction to mindfulness followed by a 1-minute and 30-second mindful breathing practice and a 1-minute and 30-second mindfulness of pain practice.

Mindful Pain Management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

Shepherd's Hope Downtown Clinic

Orlando, Florida, 32805, United States

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Adam Hanley

CONTACT

850-645-9557; adam.hanley@fsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: June 17, 2025
• Study Start: April 21, 2025
• Primary Completion: April 21, 2026
• Study Completion: April 21, 2026
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)