ISRCTN10029862
已完成
未知
Hypnosis for management of breathlessness and anxiety in severe and palliative-care COPD patients: a sham-controlled crossover trial
Bligny Hospital Center0 个研究点目标入组 21 人2020年1月7日
概览
- 阶段
- 未知
- 干预措施
- 未指定
- 疾病 / 适应症
- Dyspnea (breathlessness) in patients with severe chronic obstructive pulmonary disease (COPD)
- 发起方
- Bligny Hospital Center
- 入组人数
- 21
- 状态
- 已完成
- 最后更新
- 3年前
概览
简要总结
2020 Results article in https://doi.org/10.2147/COPD.S267019 results (added 23/10/2020) 2022 Protocol article in https://doi.org/10.1183/23120541.00565-2021 (added 28/02/2023)
研究者
入排标准
入选标准
- •1\. Aged 35\-80 years
- •2\. Affiliated to a Social Security scheme or beneficiary of such a scheme
- •3\. Absence of neurological disease interfering with the passing of tests
- •4\. Capable of giving free, informed consent.
- •5\. Severe COPD with dyspnea and distension
- •6\. Hospitalized, with or without a tracheotomy
- •7\. Non\-obese
- •8\. Predicted FEV1 \<60% and FEV/FVC \<70%, with distension evidenced by chest x\-ray or predicted TLC \>120% in pulmonary function tests
- •9\. Severity marked by ongoing hospitalization, with at least one prior instance of decompensation
- •10\. Dyspneic, with resting Borg Scale score \=3
排除标准
- •1\. Pregnancy
- •2\. Mechanical ventilation during the session
- •3\. Known severe cardiac insufficiency
- •4\. Known severe pulmonary arterial hypertension
- •5\. Cancer diagnosis
- •6\. Significant cognitive impairment, hypercapnic encephalopathy or confusional syndrome
- •7\. Deafness
- •8\. Anemia (hemoglobin \=8 g/dl)
- •9\. Psychotic pathology
- •10\. Anti\-epileptic treatment
结局指标
主要结局
未指定
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尚未招募
3 期
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