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Brief Mindfulness Intervention for Patients at a Free Acute Care Clinic

Brief Behavioral Intervention for Pain (Shepherd's Hope)

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07025161
Enrollment
200
Registered
2025-06-17
Start date
2025-04-21
Completion date
2026-04-21
Last updated
2025-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

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.

Interventions

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

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.

Sponsors

Florida State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Pain Unpleasantness Numeric Rating ScaleImmediately before to after 4-minute audio recordingSingle Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most unpleasant pain imaginable.

Secondary

MeasureTime frameDescription
Change in Pain Intensity Numeric Rating ScaleImmediately before to after 4-minute audio recordingSingle 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 ScaleImmediately before to after 4-minute audio recordingSingle Likert scale item ranging from 0-10, with 0 indicating no anxiety and 10 representing severe anxiety.

Countries

United States

Contacts

Primary ContactAdam Hanley
adam.hanley@fsu.edu850-645-9557

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026