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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07562412
Enrollment
300
Registered
2026-05-01
Start date
2026-04-29
Completion date
2027-04-30
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pain, Chronic Pain, Mindfulness, Orthopedic, Pain, Pain Management

Brief summary

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.

Interventions

BEHAVIORAL1-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.

BEHAVIORAL2-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.

BEHAVIORAL3-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.

Sponsors

Florida State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Pain Unpleasantness Numeric Rating ScaleImmediately before to after the 1- to 3-minute audio recordingChange 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

MeasureTime frameDescription
Change in Pain Intensity Numeric Rating ScaleImmediately before to after the 1- to 3-minute audio recordingChange 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.

Countries

United States

Contacts

CONTACTAdam Hanley
adam.hanley@fsu.edu850-645-9557

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 14, 2026