Developing and Testing a Multicomponent Breathwork Intervention for Adults With Chronic Pain
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Treatment Acceptability
研究概览
简要总结
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.
详细描述
Multiple single-arm iterations of an 8-week 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. 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women 18-70 years of age.
- •Chronic primary low back pain that has persisted for at least 3 months and on most days for the past 6 months.
- •Average pain intensity of ≥ 4/10 for the past month.
- •Fluent in English.
- •Access to internet with a valid email address.
- •Able to lay down and stay relatively still for one hour.
排除标准
- •Leg pain, or any other chronic pain, that is greater than low back pain.
- •Back pain possibly due to specific conditions (e.g., cancer, infection).
- •Ongoing legal action or disability claim related to low back pain.
- •Neurological symptoms associated with low back pain, including loss of control or incontinence of bowel or bladder.
- •Systemic rheumatic disease/condition (e.g. rheumatoid arthritis, systemic lupus erythematosus, fibromyalgia).
- •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.
- •Uncontrolled hypertension (i.e. SBP/DBP of > 160/95) or orthostatic hypotension (e.g., issues with fainting).
- •Neurological disease (e.g. Parkinson's, multiple sclerosis, epilepsy, history of seizures) or evidence of previous brain injury, including stroke and traumatic brain injury.
- •Serious acute physical injuries or any surgery within the past 6 months.
- •Serious psychiatric disorder (e.g., schizophrenia) or mental health issues requiring hospitalization within the past 12 months or currently on anti-psychotic medications.
- •History of hospitalization or treatment of substance use disorder within the past 12 months.
- •Currently undergoing curative or palliative chemotherapy or radiation. Pregnant or plan to become pregnant during the study period.
- •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.
研究组 & 干预措施
Integrative Breathwork Intervention
The integrative, multicomponent breathwork intervention that will be tested in this study is called Guided Respiration Mindfulness Therapy. Participants will receive a 60 minute breathwork session once a week for 8 weeks.
干预措施: Integrative Breathwork Intervention (Behavioral)
结局指标
主要结局
Treatment Acceptability
时间窗: Post-treatment (after the 8-week intervention)
Treatment acceptability and participant satisfaction of the breathwork intervention will be measured using the Client Satisfaction Questionnaire and several face valid items. (0-10; higher values = greater treatment acceptability and satisfaction).
Participant Retention
时间窗: Post-treatment (Week 8)
Percentage of randomized participants who complete post-treatment assessment.
Intervention Adherence
时间窗: Post-treatment (Week 8)
Percentage of intervention sessions attended by participants.
Change in Pain Intensity
时间窗: Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.
The Pain, Enjoyment, and General Activities (PEG-3) scale will be used to assess pain intensity over the past week on average. (0-10; higher values = greater pain intensity).
Change in Pain Interference
时间窗: Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.
The Pain, Enjoyment, and General Activities (PEG-3) will be used assess pain interference over the past week. (0-10; higher values = greater pain interference).
次要结局
- Change in Fear Avoidance Beliefs(Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.)
- Change in Fatigue(Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.)
- Change in Stress(Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.)
- Change in Interoception(Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.)
- Change in Mindful Reappraisal of Pain Sensations(Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.)
- Treatment Credibility(After Intervention session 3)
- Change in Anxiety(Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.)
- Acute Treatment Effects(Before and after each intervention sessions (Weeks 1-8))
- Change in Physical Function(Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.)
- Change in Sleep Disturbance(Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.)
- Change in Multisensory Sensitivity(Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.)
- Change in Pain Catastrophizing(Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.)
- Change in Depression(Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.)
- Change in Pain Self-Efficacy(Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.)
- Change in Sleep Related Impairment(Change from Baseline (Week 0) to Post-treatment (Week 8), 1-month follow-up.)