Breathing Therapy for Patients With Medically Unexplained Physical Symptoms and Dysfunctional Breathing: A Pilot and Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Nijmegen Questionnaire
研究概览
简要总结
Medically unexplained physical symptoms (MUPS) capture conditions characterized by symptoms without corresponding objective findings, such as asthenia, low back pain, fibromyalgia, irritable bowel syndrome, or chronic fatigue syndrome. In order to establish the grounds for a RCT. this pilot study aims to investigate the effectiveness and feasibility of a 5-week breathing retraining programme on patients who meet the criteria for MUPS.
详细描述
Medically unexplained physical symptoms (MUPS) are symptoms without an identifiable organic cause that lead to functional impairment. MUPS is highly prevalent in general practice consultations. This pilot study aimed to investigate the effectiveness and feasibility of a 5-week breathing retraining program for patients meeting the criteria for MUPS. The study used a quantitative observational design with pre- and post-intervention measurements. Fifteen participants with MUPS and dysfunctional breathing (assessed by the Nijmegen Questionnaire) were recruited from two general practitioner offices. The intervention consisted of 5 weekly sessions including education on breathing physiology and weekly breathing exercises focused on nasal breathing and resonance breathing techniques. One week post intervention, improvements were observed in dysfunctional breathing scores, lower symptom severity, higher general well-being, and reduced musculoskeletal pain complaints. At 3 months post-intervention, sustained improvements were seen in dysfunctional breathing, general well-being, musculoskeletal pain, and additionally lower pseudoneurological, gastrointestinal, and allergy complaints, as well as lower overall symptom burden and improved end-tidal CO2 levels.
The study concluded that the 5-week breathing program showed promising results for improving multiple patient-reported outcomes in MUPS. Recruitment, adherence, and acceptability of the program were satisfactory. A randomized controlled trial is recommended to further evaluate the efficacy of this breathing intervention for MUPS patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
The principal investigator kept all records and collected data, which was blinded from the care provider, whose role was solely to perform lectures and exercises.,
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •dysfunctional breathing,
- •sufficient laguage skills to fill out forms
排除标准
- •Participants with asthma
- •Participants with,chronic obstructive pulmonary disease
- •Participants with respiratory allergy that is not optimally treated medically.
结局指标
主要结局
Nijmegen Questionnaire
时间窗: Base line, end of intervention, and 3 months post-interventions
To detect dysfunctional breathing (DB). The NQ consists of 16 questions ranked on a five-point Likert scale where "never" counts as 0 and "very often" counts as 4, giving a total DB score between 0-64. Healthy, asymptomatic individuals generally have a DB score between 7-12. A score above 19 is suggestive of DB.
Carbon dioxide levels
时间窗: Base line, end of intervention, and 3 months post-interventions
End-tidal CO2 (EtCO2) (Microstream™) is an objective measure of hyperventilation and is easily detected through a nasal cannula with a capnograph together with respiratory rate (RR). The normal values of EtCO2 are 4.7 kPa - 6 kPa (45). Values below 4.6 are regarded as hypocapnia.
Subjective Health Complaints Inventory
时间窗: Base line, end of intervention, and 3 months post-interventions
Measures 29 subjective health problems. The form lists 29 common somatic and psychological ailments, where the degree of complaints and duration must be stated for the last 30 days, graded on a four-point scale. The 29 individual health issues were grouped into five sub-issues \[musculoskeletal pain (8 items), pseudoneurology (7 items), gastrointestinal disorders (7 items), allergic disorders (5 items), colds (2 items)\], and a total score comprising all items. All scales were scored 0-100 (where 0 indicates no symptom pressure and 100 the highest possible symptom pressure).
Measure Yourself Medical Outcome Profile
时间窗: Base line, end of intervention, and 3 months post-interventions
Participants are asked to rate four items (symptom 1, symptom 2, well-being, and impact of symptoms on their daily activity status) on a scale of 0-6 where 0 is "As good as it could be" and 6 is "As bad as it could be". Participants report one or two symptoms (physical or mental) which bother them the most, consider how bad each symptom was during the last week, and score them accordingly. They also report how much these symptoms affected a particular activity, their well-being during the last week, use of medication, and any possible adverse effects or worsening of symptoms. The symptom pressure and general well-being (scales 0-6) are presented.
Heart rate variability
时间窗: Base line, end of intervention, and 3 months post-interventions
The registrations of HRV were performed using HeartMath with the participants in a sitting position, relaxed, and breathing regularly. In the 1990s, HeartMath Institute researchers identified a physiological state called heart coherence. Physiologically, the coherence state is marked by the development of a smooth, sine-wave-like pattern in the heart rate variability trace. This characteristic pattern, called heart rhythm coherence, is the primary indicator of the psychophysiological coherence state. The emWave Coherence score is a measure of the degree of coherence in the heart rhythm pattern. A coherent heart rhythm is a stable, regular, repeating rhythm resembling a sine wave at a single frequency between 0.04 - 0.24 Hz (3 - 15 cycles per minute). The more stable and regular the heart rhythm frequency, the higher the coherence score. Scores range from 0 - 16.
次要结局
- Patient adherence and attrition rates(Base line, end of intervention, and 3 months post-interventions)
研究者
Tor Ivar Karlsen
Professor
University of Agder