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NCT Number: NCT07562412

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

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.

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Key information

Conditions

Pain Acute Pain Agnosia Chronic Pain Mindfulness Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Orthopedic Pain Management Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tallahassee Orthopedic Clinic

Tallahassee, Florida, 32310, United States

Location status: Recruiting

Location contact

Emilie Miley

CONTACT

[email protected]

850-877-8174

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

1-Minute Mindfulness Intervention

Behavioral

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.

2-Minute Mindfulness Intervention

Behavioral

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.

3-Minute Mindfulness Intervention

Behavioral

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.

Primary outcomes

  1. Change in Pain Unpleasantness Numeric Rating Scale

    Time frame: Immediately before to after the 1- to 3-minute audio recording

    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.

Secondary outcomes

  1. Change in Pain Intensity Numeric Rating Scale

    Time frame: Immediately before to after the 1- to 3-minute audio recording

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Adam Hanley

CONTACT

[email protected]

850-645-9557

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 1, 2026
Registry last updated
Jul 13, 2026

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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