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Brief Mindfulness Intervention for Orthopedic Patients

Sponsor
Florida State University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06099964
Collaborator
(none)
80
Enrollment
2
Arms
14.3
Anticipated Duration (Months)

Study Details

Study Description

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 orthopedic patients will be investigated relative to a 4-minute audio-recoding about pain psychoeducation.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Pain Coping Information
  • Behavioral: Mindful Pain Management
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Brief Mindfulness Intervention for a Heterogenous Mix of Orthopedic Patients
Anticipated Study Start Date :
Oct 23, 2023
Anticipated Primary Completion Date :
Oct 23, 2024
Anticipated Study Completion Date :
Jan 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Pain Coping Information

Behavioral: Pain Coping Information
A 4-minute audio recording providing common pain coping techniques (e.g., ice, rest, medication, surgery).
Experimental: Mindful Pain Management

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.

Outcome Measures

Primary Outcome Measures

  1. Change in Pain Unpleasantness Numeric Rating Scale [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 Outcome Measures

  1. Change in Pain Intensity Numeric Rating Scale [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 Anxiety Numeric Rating Scale [Immediately before to after 4-minute audio recording]

    Single Likert scale item ranging from 0-10, with 0 indicating no anxiety and 10 representing severe anxiety.

  3. Change in Depression Numeric Rating Scale [Immediately before to after 4-minute audio recording]]

    Single Likert scale item ranging from 0-10, with 0 indicating no depression and 10 indicating severe depression.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Age ≥18

  • Seeking foot or ankle treatment at the Tallahassee Orthopedic Center

Exclusion Criteria:

  • • Cognitive impairment preventing completion of study procedures.

  • Current cancer diagnosis,

  • Other unstable illness judged by medical staff to interfere with study involvement.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Florida State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Adam Hanley, Principal Investigator, Florida State University
ClinicalTrials.gov Identifier:
NCT06099964
Other Study ID Numbers:
  • IRB_00085446 2
First Posted:
Oct 25, 2023
Last Update Posted:
Oct 25, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Oct 25, 2023