Dose-Response Effects of a Brief Audio-Guided Mindfulness Intervention for Acute Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFlorida State University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Receiving treatment at Tallahassee Orthopedic Center
Understanding English instructions fluently
Being 18 years of age or older
Disqualifiers
Unable to consent because of physical or mental incapacity.
Trial design
Design model
Parallel
Treatments tested in this trial
1-Minute Mindfulness Intervention
BehavioralParticipants 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
BehavioralParticipants 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
BehavioralParticipants 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.
Treatment groups
300 Participants
are divided into 3 treatment groupsGroup A: 1-Minute Mindfulness InterventionActive comparator 1 intervention
Group B: 2-Minute Mindfulness InterventionActive comparator 1 intervention
Group C: 3-Minute Mindfulness InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Immediately before to after the 1- to 3-minute audio recordingSecondary outcomes
1
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.
Time frame
Immediately before to after the 1- to 3-minute audio recordingSponsors and contacts
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Source ClinicalTrials.gov