Chronic PainNCT06977984
Group Integrative Breathwork for Chronic Pain
A study testing Integrative Breathwork Intervention in people with Chronic Pain, run by University of Florida at 1 site in United States.
Trial summary
The aim of the proposed research is to iteratively develop, pilot test, and refine an integrative breathwork intervention that is suitable for group delivery to individuals with chronic pain. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Integrative Breathwork Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2025to 31 Mar 2026
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women 18-70 years of age.
- Chronic musculoskeletal pain lasting for at least 3 months as a symptom of axial pain (e.g., back, neck) or limb pain (e.g., shoulder, knee, hip, wrist).
- Average pain intensity of ≥ 4/10 for the past month.
- Access to internet with a valid email address
- Able to lay down and stay relatively still for one hour.
Who cannot join
- Any suspicion of a medical (orthopedic, rheumatic or neurological) disease, that can fully explain the current level of severity of pain.
- Chronic pain possibly due to specific conditions (e.g., cancer, infection).
- Ongoing legal action or disability claim related to chronic pain.
- Neurological disease (e.g. Parkinson's, multiple sclerosis, epilepsy, history of seizures) or moderate or severe symptoms from a previous brain injury, including stroke and traumatic brain injury.
- Respiratory disorder (e.g., chronic obstructive pulmonary disease) or moderate to severe asthma within the past 12 months.
- Activity limiting heart disease including cardiovascular or peripheral arterial disease.
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- Uncontrolled hypertension (i.e. SBP/DBP of > 160/95) or orthostatic hypotension (e.g., issues with fainting).
- Serious acute physical injuries or major surgery within the past 6 months.
- Serious psychiatric disorder (e.g., schizophrenia, panic disorder) or mental health issues requiring hospitalization within the past 12 months or currently on antipsychotic medications.
- History of hospitalization or treatment of substance use disorder within the past 12 months.
- Currently undergoing curative or palliative chemotherapy or radiation.
- Pregnant.
- Glaucoma or detached retina.
- Current participation or participation in the past 2 months of an interventional research study.
- Cognitive impairment or factors that would preclude comprehension of material and/or full participation in the study.
- Any significant comorbidities or other reasons that, in the opinion of the investigators, could interfere with the study or lead to deleterious effects for the participant.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida Clinical Research Center
Gainesville, Florida, 32603
About this study
Official title: Group Breathwork Intervention for Chronic Pain
The aim of the proposed research is to iteratively develop, pilot test, and refine an integrative breathwork intervention that is suitable for group delivery to individuals with chronic pain. The intervention will be evaluated for feasibility, acceptability, and plausibility for clinically significant effects in people with chronic musculoskeletal pain.
Read the detailed description
Multiple single-arm iterations of a group breathwork intervention will be conducted to refine and optimize the intervention and protocol. Upon completion of each iteration, quantitative and qualitative data will be gathered to identify possible modifications before proceeding with the next iteration. After achieving a satisfactory intervention, we will conduct a pilot randomized controlled trial compared to a waitlist control group. This work will provide initial evidence on the feasibility, acceptability, and plausibility of clinically significant effects of this type of multicomponent breathwork intervention for adults with chronic low back pain.
- Conditions
- Chronic Pain
- Being tested
- Integrative Breathwork Intervention
- Keywords
- Breathwork, Chronic Pain, Integrative Breathwork Intervention, Chronic Musculoskeletal Pain, Breathing Therapy, Intervention Development
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrative Breathwork InterventionBehavioural
The breathwork intervention involves a sustained conscious connected breathing pattern where there is no pause between inhale and exhale. During the breathing, a participant is guided to pay attention to the strongest sensation from moment-to-moment (e.g., mindfulness of somatic sensations) and relax unnecessary effort or tension. Participants lay supine throughout the 60 minute session. The session ends with spontaneous, relaxed breathing and an opportunity to briefly share one's experience.
| Study group | Role | What they receive |
|---|---|---|
| Integrative Breathwork Intervention | Experimental | The breathwork intervention will be delivered in groups of 2-5 participants with chronic musculoskeletal pain. A conscious connected breathing technique will be engaged in for 45-60 minutes. Receives: Behavioral: Integrative Breathwork Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Acceptability
Treatment acceptability and satisfaction of the breathwork intervention will be measured using several face-valid items rated on a 10-point scale (1-10) where higher scores represent greater treatment acceptability and satisfaction.
Measured: Day 1
Change in Pain Intensity and Interference
The Pain, Enjoyment, and General Activities (PEG-3) scale will be used to assess pain intensity and pain interference over the past week on average.
Measured: Change from Baseline to 1-week follow-up, 1-month follow-up
Secondary outcomes (15)
Patient's Global Impressions of Change
The Patient's Global Impression of Change single-item measure asks participants to describe any changes in activity limitations, symptoms, emotions, and overall quality of life, related to their pain since the beginning of the treatment. (Higher scores represent greater impressions of benefit from the intervention.)
Measured: 1-week follow-up, 1-month follow-up
Change in Pain Catastrophizing
Assessed using the 13-item Pain Catastrophizing Scale. (Scores range from 0-52; higher scores represent higher levels of pain catastrophizing).
Measured: Change from Baseline to 1-week follow-up, 1-month follow-up
Acute Treatment Effects
Assessed using face-valid items related to feelings and emotions immediately before and after the intervention session. Scores will be calculated by subtracting post-intervention to pre-intervention where higher scores represent greater acute subjective effects.
Measured: Day 1
Change in Pain Self-Efficacy
Assessed using the 10-item Pain Self-Efficacy Scale. (0-6; higher scores represent higher levels of pain self-efficacy).
Measured: Change from Baseline to 1-month follow-up
Change in Sleep Disturbances
Assessed using the PROMIS-Sleep Disturbance 8b scale. (1-5; higher scores represent higher levels of sleep disturbance).
Measured: Change from Baseline to 1-week follow-up, 1-month follow-up
Change in Sleep Related Impairment
Assessed using the PROMIS-Sleep Related Impairment 8a scale. (1-5; higher scores represent higher levels of sleep related impairment).
Measured: Change from Baseline to 1-week follow-up, 1-month follow-up
Change in Fatigue
Assessed using the PROMIS Fatigue-8a scale. (1-5; higher scores represent higher levels of fatigue over the past week).
Measured: Change from Baseline to 1-week follow-up, 1-month follow-up
Change in Whole Person Health
Assessed using the Whole Person Health Index. (1-5; lower scores represent better levels of self-assessed health ).
Measured: Change from Baseline to 1-month follow-up
Change in Stress
Assessed using the 4-item Perceived Stress Scale. (0-4; higher scores represent higher levels of subjective stress over the past month).
Measured: Change from Baseline to 1-week follow-up, 1-month follow-up
Change in Anxiety
Assessed using the Generalized Anxiety Disorder-2 Questionnaire. (0-3; higher scores represent higher levels of anxiety over the past 2 weeks).
Measured: Change from Baseline to 1-week follow-up, 1-month follow-up
Change in Depression
Assessed using the Patient Health Questionnaire-2.(0-3; higher scores represent higher levels of depression over the past 2 weeks).
Measured: Change from Baseline to 1-week follow-up, 1-month follow-up
Change in Fear Avoidance Beliefs
Assessed using the 5-item Fear-Avoidance Beliefs Questionnaire-physical activity subscale. (0-6; higher scores represent higher levels of physical activity-related fear-avoidance beliefs).
Measured: Change from Baseline to 1-week follow-up, 1-month follow-up
Change in Interoception
Assessed using the Multidimensional Assessment of Interoceptive Awareness-2. (0-5; higher scores represent higher levels of interoception).
Measured: Change from Baseline to 1-month follow-up
Change in Multisensory Sensitivity
Assessed using the Multisensory Amplification Scale will be used to assess symptoms of central nervous system hypersensitivity, or central sensitization. (1-5; higher scores represent higher levels of sensory sensitivity).
Measured: Change from Baseline to 1-month follow-up
Psychological Insight
Assessed using the Psychological Insight Questionnaire where higher scores represent greater levels of psychological insight arising from the breathwork intervention.
Measured: 1-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start18 Jun 2025
- Primary completion18 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Model description
- We will conduct multiple single-arm iterations testing and refining the group breathwork intervention prior to conducting a pilot randomized controlled trial comparing the refined version of the intervention to a waitlist control group.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06977984
- Sponsor's protocol ID
- IRB202500383
- Status last verified
- Apr 2026
- First submitted
- 6 May 2025
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Breathwork Intervention for Chronic Pain
- ClinicalTrials.gov ID
- NCT06977984
- Acronym / sponsor ID
- IRB202500383
- Conditions
- Chronic Pain
- Keywords
- Breathwork, Chronic Pain, Integrative Breathwork Intervention, Chronic Musculoskeletal Pain, Breathing Therapy, Intervention Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 18 Jun 2025 (actual)
- Primary completion
- 18 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 18 May 2025 (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.
The aim of the proposed research is to iteratively develop, pilot test, and refine an integrative breathwork intervention that is suitable for group delivery to individuals with chronic pain. The intervention will be evaluated for feasibility, acceptability, and plausibility for clinically significant effects in people with chronic musculoskeletal pain.
Detailed description
Multiple single-arm iterations of a group breathwork intervention will be conducted to refine and optimize the intervention and protocol. Upon completion of each iteration, quantitative and qualitative data will be gathered to identify possible modifications before proceeding with the next iteration. After achieving a satisfactory intervention, we will conduct a pilot randomized controlled trial compared to a waitlist control group. This work will provide initial evidence on the feasibility, acceptability, and plausibility of clinically significant effects of this type of multicomponent breathwork intervention for adults with chronic low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- We will conduct multiple single-arm iterations testing and refining the group breathwork intervention prior to conducting a pilot randomized controlled trial comparing the refined version of the intervention to a waitlist control group.
| Arm | Type | Receives |
|---|---|---|
| Integrative Breathwork Intervention | Experimental | Behavioral: Integrative Breathwork InterventionThe breathwork intervention will be delivered in groups of 2-5 participants with chronic musculoskeletal pain. A conscious connected breathing technique will be engaged in for 45-60 minutes. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women 18-70 years of age.
- Chronic musculoskeletal pain lasting for at least 3 months as a symptom of axial pain (e.g., back, neck) or limb pain (e.g., shoulder, knee, hip, wrist).
- Average pain intensity of ≥ 4/10 for the past month.
- Access to internet with a valid email address
- Able to lay down and stay relatively still for one hour.
Key exclusion criteria (16 listed)
- Any suspicion of a medical (orthopedic, rheumatic or neurological) disease, that can fully explain the current level of severity of pain.
- Chronic pain possibly due to specific conditions (e.g., cancer, infection).
- Ongoing legal action or disability claim related to chronic pain.
- Neurological disease (e.g. Parkinson's, multiple sclerosis, epilepsy, history of seizures) or moderate or severe symptoms from a previous brain injury, including stroke and traumatic brain injury.
- Respiratory disorder (e.g., chronic obstructive pulmonary disease) or moderate to severe asthma within the past 12 months.
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 |
|---|---|---|
| Integrative Breathwork InterventionThe breathwork intervention involves a sustained conscious connected breathing pattern where there is no pause between inhale and exhale. During the breathing, a participant is guided to pay attention to the strongest sensation from moment-to-moment (e.g., mindfulness of somatic sensations) and relax unnecessary effort or tension. Participants lay supine throughout the 60 minute session. The session ends with spontaneous, relaxed breathing and an opportunity to briefly share one's experience. | Behavioural | Integrative Breathwork Intervention |
Primary outcome
Treatment Acceptability
Time frame: Day 1
Treatment acceptability and satisfaction of the breathwork intervention will be measured using several face-valid items rated on a 10-point scale (1-10) where higher scores represent greater treatment acceptability and satisfaction.
Change in Pain Intensity and Interference
Time frame: Change from Baseline to 1-week follow-up, 1-month follow-up
The Pain, Enjoyment, and General Activities (PEG-3) scale will be used to assess pain intensity and pain interference over the past week on average.
15 secondary outcomes
Patient's Global Impressions of Change
Time frame: 1-week follow-up, 1-month follow-up
Change in Pain Catastrophizing
Time frame: Change from Baseline to 1-week follow-up, 1-month follow-up
Acute Treatment Effects
Time frame: Day 1
Change in Pain Self-Efficacy
Time frame: Change from Baseline to 1-month follow-up
Change in Sleep Disturbances
Time frame: Change from Baseline to 1-week follow-up, 1-month follow-up
Change in Sleep Related Impairment
Time frame: Change from Baseline to 1-week follow-up, 1-month follow-up
Change in Fatigue
Time frame: Change from Baseline to 1-week follow-up, 1-month follow-up
Change in Whole Person Health
Time frame: Change from Baseline to 1-month follow-up
Change in Stress
Time frame: Change from Baseline to 1-week follow-up, 1-month follow-up
Change in Anxiety
Time frame: Change from Baseline to 1-week follow-up, 1-month follow-up
Change in Depression
Time frame: Change from Baseline to 1-week follow-up, 1-month follow-up
Change in Fear Avoidance Beliefs
Time frame: Change from Baseline to 1-week follow-up, 1-month follow-up
Change in Interoception
Time frame: Change from Baseline to 1-month follow-up
Change in Multisensory Sensitivity
Time frame: Change from Baseline to 1-month follow-up
Psychological Insight
Time frame: 1-month follow-up
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 9 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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 Integrative Breathwork Intervention in people with Chronic Pain, run by University of Florida 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 5 inclusion and 16 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 9 Apr 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?
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?
Treatment Acceptability (time frame: Day 1). The study lists 2 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 9 Apr 2026.