PainNCT06718218
A Combination Mindfulness and Music Intervention for Acute Pain
A study testing Mindfulness Pain Management, Mindfulness Recording With Sustained Tone and Mindfulness Recording with Binaural Beats in people with Pain and Acute Pain, run by Florida State University at 1 site in United States.
Trial summary
This project is a single-site, four-arm, randomized controlled trial evaluating a combination mindfulness + music intervention on acute pain among patients in an orthopedic clinic waiting room. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Acute Pain
- What is being tested?
- Mindfulness Pain Management, Mindfulness Recording With Sustained Tone and Mindfulness Recording with Binaural Beats
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2024to 9 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Being 18 years of age or older
- Receiving pain treatment at Tallahassee Orthopedic Center
- Understanding English instructions fluently
Who cannot join
- Unable to consent because of physical or mental incapacity.
Trial locations and contacts
1 site in 1 country.
United States1 site
Tallahassee Orthopedic Clinic (TOC)
Tallahassee, Florida, 32308
About this study
This project is a single-site, four-arm, randomized controlled trial evaluating a combination mindfulness + music intervention on acute pain among patients in an orthopedic clinic waiting room. Participants will be randomized to one of four conditions: 1) a 5-minute mindfulness recording, 2) a 5-minute mindfulness recording with an accompanying sustained tone at 65.41 Hertz, 3) a 5-minute mindfulness recording with an accompanying binaural beat set at 65.41 Hertz in the left ear and 69.41 Hertz in the right ear, or 4) a 5-minute mindfulness recording with an accompanying binaural beat set at 65.41 Hertz in the left ear and 69.41 Hertz in the right ear as well as instrumental, theta wave music.
- Conditions
- Pain, Acute Pain
- Being tested
- Mindfulness Pain Management, Mindfulness Recording With Sustained Tone, Mindfulness Recording with Binaural Beats, Mindfulness Recording with Binaural Beats and Theta Music
- Keywords
- Mindfulness
- Medical subject headings
- Pain, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Pain ManagementBehavioural
Participants will listen to a 5-minute audio recording of a mindfulness exercise consisting of a 1-minute introduction to mindful pain management and a 4-minute mindfulness practice.
Mindfulness Recording With Sustained ToneBehavioural
Participants will listen to a 5-minute audio recording of a mindfulness exercise consisting of a 1-minute introduction to mindful pain management and a 4-minute mindfulness practice, that is accompanied by a sustained low C tone at 65.41 Hertz.
Mindfulness Recording with Binaural BeatsBehavioural
Participants will listen to a 5-minute audio recording of a mindfulness exercise consisting of a 1-minute introduction to mindful pain management and a 4-minute mindfulness practice that is accompanied by binaural beats resulting from the delivery of a sustained 65.41 Hertz tone in the left ear and a sustained 69.41 Hertz tone in the right ear.
Mindfulness Recording with Binaural Beats and Theta MusicBehavioural
Participants will listen to a 5-minute audio recording of a mindfulness exercise consisting of a 1-minute introduction to mindful pain management and a 4-minute mindfulness practice that is accompanied by binaural beats resulting from the delivery of a sustained 65.41 Hertz tone in the left ear and a sustained 69.41 Hertz tone in the right ear as well as instrumental theta wave music.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Pain Management | Active comparator | Not described Receives: Behavioral: Mindfulness Pain Management |
| Mindfulness Recording With Sustained Tone | Experimental | Not described Receives: Behavioral: Mindfulness Recording With Sustained Tone |
| Mindfulness Recording with Binaural Beats | Experimental | Not described Receives: Behavioral: Mindfulness Recording with Binaural Beats |
| Mindfulness Recording with Binaural Beats and Theta Music | Experimental | Not described Receives: Behavioral: Mindfulness Recording with Binaural Beats and Theta Music |
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 and after 5-minute audio recording
Secondary outcomes (2)
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 and after 5-minute audio recording
Change in Anxiety Numeric Rating Scale
Change in anxiety from baseline will be assessed with an item adapted from the Generalized Anxiety Disorder 2-item. Scores range from 0 to 10, with higher scores reflecting greater anxiety.
Measured: Immediately before and after 5-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 posted5 Dec 2024
- Study start2 Dec 2024
- Primary completion9 Apr 2025
- Study completion9 Apr 2025
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 218 participants (actual)
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
- NCT06718218
- Sponsor's protocol ID
- STUDY00004916_BB
- Status last verified
- Aug 2025
- First submitted
- 2 Dec 2024
- Last updated
- 14 Aug 2025
- 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 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Combination Mindfulness and Music Intervention for Acute Pain
- ClinicalTrials.gov ID
- NCT06718218
- Acronym / sponsor ID
- STUDY00004916_BB
- Conditions
- Pain, Acute Pain
- Keywords
- Mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- 9 Apr 2025 (actual)
- Study completion
- 9 Apr 2025 (actual)
- First posted
- 5 Dec 2024 (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, four-arm, randomized controlled trial evaluating a combination mindfulness + music intervention on acute pain among patients in an orthopedic clinic waiting room. Participants will be randomized to one of four conditions: 1) a 5-minute mindfulness recording, 2) a 5-minute mindfulness recording with an accompanying sustained tone at 65.41 Hertz, 3) a 5-minute mindfulness recording with an accompanying binaural beat set at 65.41 Hertz in the left ear and 69.41 Hertz in the right ear, or 4) a 5-minute mindfulness recording with an accompanying binaural beat set at 65.41 Hertz in the left ear and 69.41 Hertz in the right ear as well as instrumental, theta wave music.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Pain Management | Active comparator | Behavioral: Mindfulness Pain Management |
| Mindfulness Recording With Sustained Tone | Experimental | Behavioral: Mindfulness Recording With Sustained Tone |
| Mindfulness Recording with Binaural Beats | Experimental | Behavioral: Mindfulness Recording with Binaural Beats |
| Mindfulness Recording with Binaural Beats and Theta Music | Experimental | Behavioral: Mindfulness Recording with Binaural Beats and Theta Music |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being 18 years of age or older
- Receiving pain treatment at Tallahassee Orthopedic Center
- Understanding English instructions fluently
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 |
|---|---|---|
| Mindfulness Pain ManagementParticipants will listen to a 5-minute audio recording of a mindfulness exercise consisting of a 1-minute introduction to mindful pain management and a 4-minute mindfulness practice. | Behavioural | Mindfulness Pain Management |
| Mindfulness Recording With Sustained ToneParticipants will listen to a 5-minute audio recording of a mindfulness exercise consisting of a 1-minute introduction to mindful pain management and a 4-minute mindfulness practice, that is accompanied by a sustained low C tone at 65.41 Hertz. | Behavioural | Mindfulness Recording With Sustained Tone |
| Mindfulness Recording with Binaural BeatsParticipants will listen to a 5-minute audio recording of a mindfulness exercise consisting of a 1-minute introduction to mindful pain management and a 4-minute mindfulness practice that is accompanied by binaural beats resulting from the delivery of a sustained 65.41 Hertz tone in the left ear and a sustained 69.41 Hertz tone in the right ear. | Behavioural | Mindfulness Recording with Binaural Beats |
| Mindfulness Recording with Binaural Beats and Theta MusicParticipants will listen to a 5-minute audio recording of a mindfulness exercise consisting of a 1-minute introduction to mindful pain management and a 4-minute mindfulness practice that is accompanied by binaural beats resulting from the delivery of a sustained 65.41 Hertz tone in the left ear and a sustained 69.41 Hertz tone in the right ear as well as instrumental theta wave music. | Behavioural | Mindfulness Recording with Binaural Beats and Theta Music |
Primary outcome
Change in Pain Unpleasantness Numeric Rating Scale
Time frame: Immediately before and after 5-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.
2 secondary outcomes
Change in Pain Intensity Numeric Rating Scale
Time frame: Immediately before and after 5-minute audio recording
Change in Anxiety Numeric Rating Scale
Time frame: Immediately before and after 5-minute audio recording
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Pain Management, Mindfulness Recording With Sustained Tone and Mindfulness Recording with Binaural Beats in people with Pain and Acute Pain, 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: finished, as of the sponsor's last update on 14 Aug 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 and after 5-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 14 Aug 2025.