PainNCT07562412
Dose-Response Effects of a Brief Audio-Guided Mindfulness Intervention for Acute Pain
A study testing 1-Minute Mindfulness Intervention, 2-Minute Mindfulness Intervention and 3-Minute Mindfulness Intervention in people with Pain and Pain Management, run by Florida State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Pain Management, Mindfulness
- What is being tested?
- 1-Minute Mindfulness Intervention, 2-Minute Mindfulness Intervention and 3-Minute Mindfulness Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2026to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Receiving treatment at Tallahassee Orthopedic Center
- Understanding English instructions fluently
- Being 18 years of age or older
Who cannot join
- Unable to consent because of physical or mental incapacity.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Tallahassee Orthopedic Clinic
Tallahassee, Florida, 32310
Emilie Miley, 850-877-8174, research@teamtoc.com
About this study
Official title: 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.
- Conditions
- Pain, Pain Management, Mindfulness, Orthopedic, Acute Pain, Chronic Pain
- Being tested
- 1-Minute Mindfulness Intervention, 2-Minute Mindfulness Intervention, 3-Minute Mindfulness Intervention
- Medical subject headings
- Pain, Agnosia, Acute Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1-Minute Mindfulness InterventionBehavioural
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 InterventionBehavioural
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 InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 1-Minute Mindfulness Intervention | Active comparator | Not described Receives: Behavioral: 1-Minute Mindfulness Intervention |
| 2-Minute Mindfulness Intervention | Active comparator | Not described Receives: Behavioral: 2-Minute Mindfulness Intervention |
| 3-Minute Mindfulness Intervention | Experimental | Not described Receives: Behavioral: 3-Minute Mindfulness Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately before to after the 1- to 3-minute audio recording
Secondary 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.
Measured: Immediately before to after the 1- to 3-minute audio recording
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start29 Apr 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Hanley, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07562412
- Sponsor's protocol ID
- STUDY00004916_Dose
- Status last verified
- Jul 2026
- First submitted
- 27 Apr 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-Response Effects of a Brief Audio-Guided Mindfulness Intervention for Acute Pain While Awaiting Orthopedic Care
- ClinicalTrials.gov ID
- NCT07562412
- Acronym / sponsor ID
- STUDY00004916_Dose
- Conditions
- Pain, Pain Management, Mindfulness, Orthopedic, Acute Pain, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 29 Apr 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1-Minute Mindfulness Intervention | Active comparator | Behavioral: 1-Minute Mindfulness Intervention |
| 2-Minute Mindfulness Intervention | Active comparator | Behavioral: 2-Minute Mindfulness Intervention |
| 3-Minute Mindfulness Intervention | Experimental | Behavioral: 3-Minute Mindfulness Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Receiving treatment at Tallahassee Orthopedic Center
- Understanding English instructions fluently
- Being 18 years of age or older
Key exclusion criteria (1 listed)
- Unable to consent because of physical or mental incapacity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1-Minute Mindfulness InterventionParticipants 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. | Behavioural | 1-Minute Mindfulness Intervention |
| 2-Minute Mindfulness InterventionParticipants 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. | Behavioural | 2-Minute Mindfulness Intervention |
| 3-Minute Mindfulness InterventionParticipants 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. | Behavioural | 3-Minute Mindfulness Intervention |
Primary outcome
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.
1 secondary outcome
Change in Pain Intensity Numeric Rating Scale
Time frame: Immediately before to after the 1- to 3-minute audio recording
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1-Minute Mindfulness Intervention, 2-Minute Mindfulness Intervention and 3-Minute Mindfulness Intervention in people with Pain and Pain Management, run by Florida State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adam Hanley (850-645-9557, adam.hanley@fsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Unpleasantness Numeric Rating Scale (time frame: Immediately before to after the 1- to 3-minute audio recording). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.