University of Florida Clinical Research Center
Gainesville, Florida, 32603, United States
NCT Number: NCT06977984
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.
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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Gainesville, Florida, 32603, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Time frame: 1-week follow-up, 1-month follow-up
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.)
Time frame: Change from Baseline to 1-week follow-up, 1-month follow-up
Assessed using the 13-item Pain Catastrophizing Scale. (Scores range from 0-52; higher scores represent higher levels of pain catastrophizing).
Time frame: Day 1
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.
Time frame: Change from Baseline to 1-month follow-up
Assessed using the 10-item Pain Self-Efficacy Scale. (0-6; higher scores represent higher levels of pain self-efficacy).
Time frame: Change from Baseline to 1-week follow-up, 1-month follow-up
Assessed using the PROMIS-Sleep Disturbance 8b scale. (1-5; higher scores represent higher levels of sleep disturbance).
Time frame: Change from Baseline to 1-week follow-up, 1-month follow-up
Assessed using the PROMIS-Sleep Related Impairment 8a scale. (1-5; higher scores represent higher levels of sleep related impairment).
Time frame: Change from Baseline to 1-week follow-up, 1-month follow-up
Assessed using the PROMIS Fatigue-8a scale. (1-5; higher scores represent higher levels of fatigue over the past week).
Time frame: Change from Baseline to 1-month follow-up
Assessed using the Whole Person Health Index. (1-5; lower scores represent better levels of self-assessed health ).
Time frame: Change from Baseline to 1-week follow-up, 1-month follow-up
Assessed using the 4-item Perceived Stress Scale. (0-4; higher scores represent higher levels of subjective stress over the past month).
Time frame: Change from Baseline to 1-week follow-up, 1-month follow-up
Assessed using the Generalized Anxiety Disorder-2 Questionnaire. (0-3; higher scores represent higher levels of anxiety over the past 2 weeks).
Time frame: Change from Baseline to 1-week follow-up, 1-month follow-up
Assessed using the Patient Health Questionnaire-2.(0-3; higher scores represent higher levels of depression over the past 2 weeks).
Time frame: Change from Baseline to 1-week follow-up, 1-month follow-up
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).
Time frame: Change from Baseline to 1-month follow-up
Assessed using the Multidimensional Assessment of Interoceptive Awareness-2. (0-5; higher scores represent higher levels of interoception).
Time frame: Change from Baseline to 1-month follow-up
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).
Time frame: 1-month follow-up
Assessed using the Psychological Insight Questionnaire where higher scores represent greater levels of psychological insight arising from the breathwork intervention.
University of Florida
Other
Group Breathwork Intervention for Chronic Pain
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