Brief Mindfulness Intervention for Patients at a Free Acute Care Clinic

NCT ID: NCT07025161

Last Updated: 2025-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-21

Study Completion Date

2026-04-21

Brief Summary

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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

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Pain Coping Information

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

Group Type ACTIVE_COMPARATOR

Pain Coping Information

Intervention Type BEHAVIORAL

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

Mindful Pain Management

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.

Group Type EXPERIMENTAL

Mindful Pain Management

Intervention Type 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.

Interventions

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Pain Coping Information

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

Intervention Type BEHAVIORAL

Mindful Pain Management

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Florida State University

OTHER

Sponsor Role lead

Responsible Party

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Adam Hanley

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shepherd's Hope Downtown Clinic

Orlando, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Adam Hanley

Role: CONTACT

850-645-9557

Other Identifiers

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STUDY00004916 Shepherd's Hope

Identifier Type: -

Identifier Source: org_study_id

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