RECRUITING

Integrative Breathwork Intervention for Chronic Pain

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The proposed research is to develop and refine a multicomponent breathwork intervention, Guided Respiration Mindfulness Therapy, and to iteratively evaluate its feasibility, acceptability, and plausibility for clinically significant effects in people with chronic low back pain. This integrative breathwork intervention involves a 60-minute breathing session where the focus is to maintain a conscious connected breathing pattern (no pause between inhale and exhale), apply mindful acceptance to somatic sensations, and relax any physical tension. Each breathwork session will be delivered 1-on-1 in person by a trained facilitator. The treatment consists of 8 breathwork sessions, once per week for 8 weeks.

Official Title

Developing and Testing a Multicomponent Breathwork Intervention for Adults With Chronic Pain

Quick Facts

Study Start:2024-10-24
Study Completion:2027-05-22
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06546956

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Men and women 18-70 years of age.
  2. * Chronic primary low back pain that has persisted for at least 3 months and on most days for the past 6 months.
  3. * Average pain intensity of ≥ 4/10 for the past month.
  4. * Fluent in English.
  5. * Access to internet with a valid email address.
  6. * Able to lay down and stay relatively still for one hour.
  1. * Leg pain, or any other chronic pain, that is greater than low back pain.
  2. * Back pain possibly due to specific conditions (e.g., cancer, infection).
  3. * Ongoing legal action or disability claim related to low back pain.
  4. * Neurological symptoms associated with low back pain, including loss of control or incontinence of bowel or bladder.
  5. * Systemic rheumatic disease/condition (e.g. rheumatoid arthritis, systemic lupus erythematosus, fibromyalgia).
  6. * Respiratory disorder (e.g., chronic obstructive pulmonary disease) or moderate to severe asthma within the past 12 months.
  7. * Activity limiting heart disease including cardiovascular or peripheral arterial disease.
  8. * Uncontrolled hypertension (i.e. SBP/DBP of \> 160/95) or orthostatic hypotension (e.g., issues with fainting).
  9. * Neurological disease (e.g. Parkinson's, multiple sclerosis, epilepsy, history of seizures) or evidence of previous brain injury, including stroke and traumatic brain injury.
  10. * Serious acute physical injuries or any surgery within the past 6 months.
  11. * Serious psychiatric disorder (e.g., schizophrenia) or mental health issues requiring hospitalization within the past 12 months or currently on anti-psychotic medications.
  12. * History of hospitalization or treatment of substance use disorder within the past 12 months.
  13. * Currently undergoing curative or palliative chemotherapy or radiation. Pregnant or plan to become pregnant during the study period.
  14. * Glaucoma or detached retina.
  15. * Current participation or participation in the past 2 months of an interventional research study.
  16. * Cognitive impairment or factors that would preclude comprehension of material and/or full participation in the study.

Contacts and Locations

Study Contact

Steven Pratscher, PhD
CONTACT
352-273-9510
Spratscher@ufl.edu

Principal Investigator

Steven Pratscher, PhD
PRINCIPAL_INVESTIGATOR
University of Florida

Study Locations (Sites)

University of Florida
Gainesville, Florida, 32610
United States

Collaborators and Investigators

Sponsor: University of Florida

  • Steven Pratscher, PhD, PRINCIPAL_INVESTIGATOR, University of Florida

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-24
Study Completion Date2027-05-22

Study Record Updates

Study Start Date2024-10-24
Study Completion Date2027-05-22

Terms related to this study

Keywords Provided by Researchers

  • Chronic pain
  • Breathwork
  • Mindfulness
  • Breathing

Additional Relevant MeSH Terms

  • Chronic Low-back Pain