A Quick Relaxation Training for People With Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Differences in patients' state of dyspnea, before and after the treatment, as assessed by the Borg Scale (BORG)
研究概览
简要总结
People with Chronic Obstructive Pulmonary Disease (COPD) suffer from dyspnoea, which may be exacerbated by psychological outcomes including anxiety and depression. Previous studies suggest that relaxation techniques may have positive effects on pulmonary rehabilitation. The main aim of this study is to explore both the respiratory and psychological impact of a quick, one-session, relaxation training for people with Chronic Obstructive Pulmonary Disease (COPD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written Informed Consent;
- •Chronic Obstructive Pulmonary Disease (COPD) diagnosis confirmed by a specialized physician;
- •basal FEV1/FVC <70%, using the standards established by Global Initiative For Chronic Obstructive Lung Disease (GOLD);
- •Modified British Medical Research Council Questionnaire (mMRC) ≥ 2;
- •COPD Assessment Test (CAT) ≥ 10.
排除标准
- •Pregnancy;
- •psychiatric disturbances;
- •oncological diseases;
- •comorbid states that determine an immunosuppressive condition.
研究组 & 干预措施
Guided Relaxation Technique
Forced Vital Capacity (FVC), Forced Expiratory Volume in the First Second (FEV1), FEV1/FVC, Heart Rate Variability (HRV), airway resistance (kPa/l/s), before and after an 11 minutes, one-session, guided relaxation technique Following 30-40 minutes questionnaire, 5 minutes heart rate (HR) and oxygen saturation (SpO2) recording, 11 minutes relaxation technique (listening via headphone to audio recording. In the meanwhile, heart rate and saturation are recording) to be completed by second heart rate (HR) and oxygen saturation (SpO2) recording. Entire procedure 60-80 minutes.
干预措施: Guided Relaxation Technique (Behavioral)
Documentary movie
Forced Vital Capacity (FVC), Forced Expiratory Volume in the First Second (FEV1), FEV1/FVC, Heart Rate Variability (HRV), airway resistance (kPa/l/s), before and after an 11 minutes documentary movie.
Following 30-40 minutes questionnaire, 5 minutes heart rate (HR) and oxygen saturation (SpO2) recording, 11 minutes documentary movie (listening via headphone. In the meanwhile, heart rate and saturation are recording) to be completed by second heart rate (HR) and oxygen saturation (SpO2) recording. Entire procedure 60-80 minutes.
干预措施: Documentary Movie (Other)
结局指标
主要结局
Differences in patients' state of dyspnea, before and after the treatment, as assessed by the Borg Scale (BORG)
时间窗: Baseline and following filling in all the psychological tests and the session of relaxation technique/documentary movie (60-80 minutes elapsed time)
次要结局
- Differences in Forced Expiratory Volume in The First Second (FEV1), before and after the treatment(Baseline and following filling in all the psychological tests and the session of relaxation technique/documentary movie (60-80 minutes elapsed time))
- Changes in airway resistance (kPa/l/s) before and after the treatment(Baseline and following filling in all the psychological tests and the session of relaxation technique/documentary movie (60-80 minutes elapsed time))
- Presence and intensity of the possible subjective experience of engaging just-manageable challenges by tackling a series of goals, continuously processing feedback about progress, and adjusting action based on this feedback, after the treatment(After the session of relaxation training/documentary movie (60-80 minutes after the baseline))
- Changes in oxygen saturation (SpO2), before, during and after the treatment(It is recorded for 5 minutes before, during and after the session of relaxation technique/documentary movie (60-80 minutes elapsed time))
- Changes in the intensity of subjective feelings, before and after the treatment, as assessed by a Visual Analogue Scale (VAS)(Before the session of relaxation training/documentary movie and after it (60-80 minutes elapsed time))
- Differences in Forced Vital Capacity (FVC), before and after the treatment(Baseline and following filling in all the psychological tests and the session of relaxation technique/documentary movie (60-80 minutes elapsed time))
- Changes in Heart Rate Variability (HRV), before, during and after the treatment(It is recorded for 5 minutes before, during and after the session of relaxation technique/documentary movie (60-80 minutes elapsed time))
- Changes in subjective feelings of anxiety, before and after the treatment, as measured by the State Trait Anxiety Inventory (STAI-Y1)(Before the session of relaxation training/documentary movie and after it (60-80 minutes elapsed time))
- Changes in the intensity of positive and negative affects, before and after the treatment, as assessed by the Positive and Negative Affective Schedule (PANAS)(Before the session of relaxation training/documentary movie and after it (60-80 minutes elapsed time))