Dose-Response Effects of a Brief Audio-Guided Mindfulness Intervention for Acute Pain

Dose-Response Effects of a Brief Audio-Guided Mindfulness Intervention for Acute Pain While Awaiting Orthopedic Care

This project is a single-site, three-arm, randomized controlled trial investigating whether different length audio-recorded mindfulness practices differentially decrease pain among patients in a waiting room awaiting orthopedic care.

Study Overview

• Status: Not yet recruiting
• Conditions: Pain; Chronic Pain; Acute Pain; Pain Management; Mindfulness; Orthopedic
• Intervention / Treatment: Behavioral: 1-Minute Mindfulness Intervention; Behavioral: 2-Minute Mindfulness Intervention; Behavioral: 3-Minute Mindfulness Intervention

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adam Hanley; Phone Number: 850-645-9557; Email: adam.hanley@fsu.edu

Study Locations

• United States
  • Florida
    • Tallahassee, Florida, United States, 32310
      • Tallahassee Orthopedic Clinic
      • Contact: Emilie Miley; Phone Number: 850-877-8174; Email: research@teamtoc.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Receiving 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1-Minute Mindfulness Intervention	Behavioral: 1-Minute Mindfulness Intervention; Participants listen to a 1-minute audio recording delivering a brief, guided mindfulness exercise focused on breath awareness. The intervention instructs participants to attend to the sensations of inhalation and exhalation, use simple mental labels (e.g., "in," "out"), and gently return attention to the breath when distracted. Participants are also encouraged to notice discomfort without attempting to change it.
Active Comparator: 2-Minute Mindfulness Intervention	Behavioral: 2-Minute Mindfulness Intervention; Participants listen to a 2-minute audio recording delivering a brief, guided mindfulness exercise focused on breath awareness. The intervention instructs participants to attend to the sensations of inhalation and exhalation, use simple mental labels (e.g., "in," "out"), and gently return attention to the breath when distracted. Participants are also encouraged to notice discomfort without attempting to change it.
Experimental: 3-Minute Mindfulness Intervention	Behavioral: 3-Minute Mindfulness Intervention; Participants listen to a 3-minute audio recording delivering a brief, guided mindfulness exercise focused on breath awareness. The intervention instructs participants to attend to the sensations of inhalation and exhalation, use simple mental labels (e.g., "in," "out"), and gently return attention to the breath when distracted. Participants are also encouraged to notice discomfort without attempting to change it.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Unpleasantness Numeric Rating Scale	Change in acute pain unpleasantness will be measured with an individual item ("How unpleasant is your pain, right now?") rated on a numeric rating scale. Scores range from 0 to 10, with higher scores reflecting greater acute pain unpleasantness.	Immediately before to after the 1- to 3-minute audio recording

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Intensity Numeric Rating Scale	Change in acute pain intensity will be measured with an individual item ("How much pain do you have, right now?") rated on a numeric rating scale. Scores range from 0 to 10, with higher scores reflecting greater acute pain intensity.	Immediately before to after the 1- to 3-minute audio recording

Collaborators and Investigators

• Sponsor: Florida State University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: April 27, 2026
• First Submitted That Met QC Criteria: April 27, 2026
• First Posted (Actual): May 1, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Chronic Pain; Acute Pain; Agnosia
• Other Study ID Numbers: STUDY00004916_Dose

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No