PainNCT06455839
Breathwork for Chronic Musculoskeletal Pain
A study testing Guided Resipiration Mindfulness Therapy (GRMT) in people with Pain and Chronic Pain, run by Florida State University at 1 site in United States.
Trial summary
This project is a single-site, single-arm, clinical feasibility trial examining the impact of a single-session, 2-hour connected consciousness breathing with breath retention (CCBR) training for chronic musculoskeletal pain. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Chronic Pain, Pain, Chronic
- What is being tested?
- Guided Resipiration Mindfulness Therapy (GRMT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2024to 27 Jul 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- having received a professional diagnosis of clinical levels of chronic pain
- being able to not commit to another (new) treatment during the course of the study
- understanding English instructions fluently
- Being 18 and above
Who cannot join
- having learned to practice breathwork any time in the past
- being unable to perform most basic tasks due to pain or pain treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brian Science and Symptom Management Center
Tallahassee, Florida, 32310
About this study
Official title: Breathwork Intervention for Individuals With Chronic Musculoskeletal Pain
This project is a single-site, single-arm, clinical feasibility trial examining the impact of a single-session, 2-hour connected consciousness breathing with breath retention (CCBR) training for chronic musculoskeletal pain.
Read the detailed description
CCBR is a breathwork style that involves breathing with no pause between inhalation and exhalation (also known as circular breathing). This breathing pattern is maintained for a given period of time, ranging from 5 minutes to over 2 hours. In the proposed project, the CCBR training will begin with a 15-minute introduction to CCBR, followed by an hour and 15 minutes of therapist-guided CCBR practice. The final 30 minutes will be used to discuss participant experiences during the CCBR practice. CCBR training sessions will occur in-person and in a small group format (5 participants each).
- Conditions
- Pain, Chronic Pain, Pain, Chronic, Musculoskeletal Pain
- Being tested
- Guided Resipiration Mindfulness Therapy (GRMT)
- Medical subject headings
- Pain, Chronic Pain, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided Resipiration Mindfulness Therapy (GRMT)Behavioural
GRMT provides training in respiratory regulation, mindfulness and relaxation. The GRMT training will begin with a 15-minute introduction to the treatment model, followed by an hour of therapist-guided respiration (i.e., continuous rhythmic expansion of the chest, and relaxed exhalation involving release of all respiratory and peripheral musculature). The final 45 minutes will be used to discuss participant experiences during the GRMT training. GRMT training sessions will occur in-person and in a small group format (<5 participants each).
| Study group | Role | What they receive |
|---|---|---|
| Guided Respiration Mindfulness Therapy | Experimental | Not described Receives: Behavioral: Guided Resipiration Mindfulness Therapy (GRMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Chronic Pain Recruited
Examine recruitment rates during the 1 week of recruitment.
Measured: 1 week
Intervention Adherence
Examine the percentage of participants completing their 2-hour intervention session.
Measured: 2 Hours
Treatment Acceptability
Treatment acceptability will be assessed with a 12-item adaptation of the Treatment Framework of Acceptability questionnaire. Scores range from 5 to 45. Higher scores reflect greater acceptability.
Measured: Completed immediately after the 2-hour GRMT training
Secondary outcomes (1)
Global Impression of Change
Treatment related improvement will be assessed with the Patient Global Impression of Change scale. Scores range from 0 to 7, with higher scores reflecting greater treatment related improvement.
Measured: Completed at 2- and 6-week follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start29 May 2024
- Primary completion11 Jun 2024
- Study completion27 Jul 2024
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 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
- NCT06455839
- Sponsor's protocol ID
- 00005048
- Status last verified
- Mar 2025
- First submitted
- 7 Jun 2024
- Last updated
- 21 Mar 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 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breathwork Intervention for Individuals With Chronic Musculoskeletal Pain
- ClinicalTrials.gov ID
- NCT06455839
- Acronym / sponsor ID
- 00005048
- Conditions
- Pain, Chronic Pain, Pain, Chronic, Musculoskeletal Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 29 May 2024 (actual)
- Primary completion
- 11 Jun 2024 (actual)
- Study completion
- 27 Jul 2024 (actual)
- First posted
- 12 Jun 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, single-arm, clinical feasibility trial examining the impact of a single-session, 2-hour connected consciousness breathing with breath retention (CCBR) training for chronic musculoskeletal pain.
Detailed description
CCBR is a breathwork style that involves breathing with no pause between inhalation and exhalation (also known as circular breathing). This breathing pattern is maintained for a given period of time, ranging from 5 minutes to over 2 hours. In the proposed project, the CCBR training will begin with a 15-minute introduction to CCBR, followed by an hour and 15 minutes of therapist-guided CCBR practice. The final 30 minutes will be used to discuss participant experiences during the CCBR practice. CCBR training sessions will occur in-person and in a small group format (5 participants each).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Guided Respiration Mindfulness Therapy | Experimental | Behavioral: Guided Resipiration Mindfulness Therapy (GRMT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- having received a professional diagnosis of clinical levels of chronic pain
- being able to not commit to another (new) treatment during the course of the study
- understanding English instructions fluently
- Being 18 and above
Key exclusion criteria (2 listed)
- having learned to practice breathwork any time in the past
- being unable to perform most basic tasks due to pain or pain treatment.
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 |
|---|---|---|
| Guided Resipiration Mindfulness Therapy (GRMT)GRMT provides training in respiratory regulation, mindfulness and relaxation. The GRMT training will begin with a 15-minute introduction to the treatment model, followed by an hour of therapist-guided respiration (i.e., continuous rhythmic expansion of the chest, and relaxed exhalation involving release of all respiratory and peripheral musculature). The final 45 minutes will be used to discuss participant experiences during the GRMT training. GRMT training sessions will occur in-person and in a small group format (<5 participants each). | Behavioural | Guided Respiration Mindfulness Therapy |
Primary outcome
Number of Participants with Chronic Pain Recruited
Time frame: 1 week
Examine recruitment rates during the 1 week of recruitment.
Intervention Adherence
Time frame: 2 Hours
Examine the percentage of participants completing their 2-hour intervention session.
Treatment Acceptability
Time frame: Completed immediately after the 2-hour GRMT training
Treatment acceptability will be assessed with a 12-item adaptation of the Treatment Framework of Acceptability questionnaire. Scores range from 5 to 45. Higher scores reflect greater acceptability.
1 secondary outcome
Global Impression of Change
Time frame: Completed at 2- and 6-week follow-ups
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 21 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Pain
RecruitingPhase 4
Analgesic Efficacy and Obstetric Effects of Tramadol, Paracetamol and Placebo in Active Labor
Labor Pain
Recruiting
Effects of Pelvic Floor Muscle Training and a Modified Lumbopelvic Belt on Pain, Kinesiophobia, and Functional Status in Pregnant Women With Symphysis Pubis Pain
Symphysis Pubis Dysfunction, Pregnancy
Not yet recruiting
Pilot Study: Clinical Trial of Ultrasound Guiding Pharmacopuncture Therapy for Acute Low Back Pain
Low Back Pain (LBP)
Not yet recruiting
Efficacy of TECAR Therapy in Plantar Fasciitis
Plantar Fasciitis
Not yet recruiting
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
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 Guided Resipiration Mindfulness Therapy (GRMT) in people with Pain and Chronic 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 4 inclusion and 2 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 21 Mar 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?
Number of Participants with Chronic Pain Recruited (time frame: 1 week). The study lists 3 primary outcomes in all. 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 21 Mar 2025.