Brief Mindfulness Intervention for Orthopedic Patients: Mechanistic Investigation

NCT ID: NCT06171009

Last Updated: 2024-09-19

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

COMPLETED

Clinical Phase

NA

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-15

Study Completion Date

2024-06-18

Brief Summary

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This is a single-site, two-arm, parallel-group randomized clinical trial (RCT). The analgesic effects of a 4-minute audio-recorded mindfulness intervention for orthopedic patients will be investigated relative to a 4-minute audio-recoding about pain psychoeducation. Analgesic mechanisms of mindfulness will also be investigated.

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

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Pain Coping Information

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

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 Tallahassee Orthopedic Center

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

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tallahassee Orthopedic Clinic (TOC)

Tallahassee, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY00004419

Identifier Type: -

Identifier Source: org_study_id

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