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OpenTrials
Completed

NCT Number: NCT06171009

Brief Mindfulness Intervention for Orthopedic Patients: Mechanistic Investigation

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tallahassee Orthopedic Clinic (TOC)

Tallahassee, Florida, 32308, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pain Coping Information

Behavioral

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

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.

Primary outcomes

  1. Change in Pain Unpleasantness Numeric Rating Scale

    Time frame: Immediately before to after 4-minute audio recording

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

Secondary outcomes

  1. Change in Pain Intensity Numeric Rating Scale

    Time frame: Immediately before to after 4-minute audio recording

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

  2. Change in Decentering

    Time frame: Immediately before to after 4-minute audio recording

    Decentering will be measured by the single, decentering item from the state version of the validated Metacognitive Processes of Decentering Scale. This item will be scored with a Likert scale item ranging from 0-10, with higher scores representing greater decentering.

  3. Change in Self-Transcendent State

    Time frame: Immediately before to after 4-minute audio recording

    Self-transcendent state will be measured by the three-item, state version of the validated Nondual Awareness Dimensional Assessment. These three items will be scored with a Likert scale item ranging from 0-10, with higher scores representing greater self-transcendence.

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Registry information

Official study title

Brief Mindfulness Intervention for Orthopedic Patients in the Clinic Waiting Room: Mechanistic Investigation

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 14, 2023
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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