Does Psychoeducation Improve the Pain Relief Derived From a Brief Intervention

NCT ID: NCT06952049

Last Updated: 2025-12-04

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

2025-04-10

Study Completion Date

2026-02-01

Brief Summary

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This project is a single-site, five-arm, randomized controlled trial investigating whether providing patients in an orthopedic clinic waiting room psychoeducation about mindfulness impacts the degree of pain relief they experience during a mindfulness-based intervention.

Detailed Description

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Conditions

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Pain Acute Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Pain Psychoeducation

In the pain psychoeducation intervention, participants will be randomized to listen to a three-minute recording about different pain management strategies (e.g., ice, rest) to promote overall well-being.

Group Type ACTIVE_COMPARATOR

Pain Psychoeducation

Intervention Type BEHAVIORAL

In the pain psychoeducation intervention, participants will be randomized to listen to a three-minute recording about different pain management strategies (e.g., ice, rest) to promote overall well-being.

Mindfulness without Psychoeducation

In the mindfulness without psychoeducation intervention, participants will be randomized to listen to a three-minute mindfulness practice consisting of 1 minute of mindful breathing, 1 minute of mindful mapping, and 1 minute of mindfulness of personal meaning.

Group Type EXPERIMENTAL

Mindfulness without Psychoeducation

Intervention Type BEHAVIORAL

In the mindfulness without psychoeducation intervention, participants will be randomized to listen to a three-minute mindfulness practice consisting of 1 minute of mindful breathing, 1 minute of mindful mapping, and 1 minute of mindfulness of personal meaning.

1 Minute Psychoeducation with 2 Minutes of Mindfulness (Pain Focus)

In the 1 Minute Psychoeducation with 2 minutes of Mindfulness (Pain Focus) intervention, participants will be randomized to listen to a 1 minute of psychoeducation about mindfulness, 1 minute of mindful breathing and 1 minute of mindful mapping.

Group Type EXPERIMENTAL

1 Minute Psychoeducation with 2 Minutes of Mindfulness (Pain Focus)

Intervention Type BEHAVIORAL

In the 1 Minute Psychoeducation with 2 minutes of Mindfulness (Pain Focus) intervention, participants will be randomized to listen to a 1 minute of psychoeducation about mindfulness, 1 minute of mindful breathing and 1 minute of mindful mapping.

1 Minute Psychoeducation with 2 Minutes of Mindfulness (Meaning Focus)

In the 1 Minute Psychoeducation with 2 minutes of Mindfulness (Meaning Focus) intervention, participants will be randomized to listen to a 1 minute of psychoeducation about mindfulness, 1 minute of mindful breathing and 1 minute of mindfulness of personal meaning.

Group Type EXPERIMENTAL

1 Minute Psychoeducation with 2 Minutes of Mindfulness (Meaning Focus)

Intervention Type BEHAVIORAL

In the 1 Minute Psychoeducation with 2 minutes of Mindfulness (Meaning Focus) intervention, participants will be randomized to listen to a 1 minute of psychoeducation about mindfulness, 1 minute of mindful breathing and 1 minute of mindfulness of personal meaning.

2 Minutes of Psychoeducation with 1 Minute of Mindfulness

In the 2 Minutes of Psychoeducation with 1 Minute of Mindfulness intervention, participants will be randomized to listen to a 2 minute of psychoeducation about mindfulness and 1 minute of mindful breathing.

Group Type EXPERIMENTAL

2 Minutes of Psychoeducation with 1 Minute of Mindfulness

Intervention Type BEHAVIORAL

In the 2 Minutes of Psychoeducation with 1 Minute of Mindfulness intervention, participants will be randomized to listen to a 2 minute of psychoeducation about mindfulness and 1 minute of mindful breathing.

Interventions

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Pain Psychoeducation

In the pain psychoeducation intervention, participants will be randomized to listen to a three-minute recording about different pain management strategies (e.g., ice, rest) to promote overall well-being.

Intervention Type BEHAVIORAL

Mindfulness without Psychoeducation

In the mindfulness without psychoeducation intervention, participants will be randomized to listen to a three-minute mindfulness practice consisting of 1 minute of mindful breathing, 1 minute of mindful mapping, and 1 minute of mindfulness of personal meaning.

Intervention Type BEHAVIORAL

1 Minute Psychoeducation with 2 Minutes of Mindfulness (Pain Focus)

In the 1 Minute Psychoeducation with 2 minutes of Mindfulness (Pain Focus) intervention, participants will be randomized to listen to a 1 minute of psychoeducation about mindfulness, 1 minute of mindful breathing and 1 minute of mindful mapping.

Intervention Type BEHAVIORAL

1 Minute Psychoeducation with 2 Minutes of Mindfulness (Meaning Focus)

In the 1 Minute Psychoeducation with 2 minutes of Mindfulness (Meaning Focus) intervention, participants will be randomized to listen to a 1 minute of psychoeducation about mindfulness, 1 minute of mindful breathing and 1 minute of mindfulness of personal meaning.

Intervention Type BEHAVIORAL

2 Minutes of Psychoeducation with 1 Minute of Mindfulness

In the 2 Minutes of Psychoeducation with 1 Minute of Mindfulness intervention, participants will be randomized to listen to a 2 minute of psychoeducation about mindfulness and 1 minute of mindful breathing.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Receiving pain treatment at Tallahassee Orthopedic Center
* Understanding English instructions fluently
* Being 18 years of age or older

Exclusion Criteria

* Unable to consent because of physical or mental incapacity.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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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Tallahassee Orthopedic Clinic (TOC)

Tallahassee, 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

Kennedi Childs

Role: CONTACT

Facility Contacts

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Emilie Miley

Role: primary

Other Identifiers

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STUDY00004916_PsychoedImpact

Identifier Type: -

Identifier Source: org_study_id

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