Messika Jonathan, Hajage David, Panneckoucke Nataly, Villard Serge, Martin Yolaine, Renard Emilie, Blivet Annie, Reignier Jean, Maquigneau Natacha, Stoclin Annabelle, Puechberty Christelle, Guétin Stéphane, Dechanet Aline, Fauquembergue Amandine, Gaudry Stéphane, Dreyfuss Didier, Ricard Jean-Damien
AP-HP, Hôpital Louis Mourier, Réanimation Médico-chirurgicale, 178 rue des Renouillers, F-92700, Colombes, France.
Université Paris Diderot, Sorbonne Paris Cité, IAME, UMRS 1137, F-75018, Paris, France.
Trials. 2016 Sep 13;17(1):450. doi: 10.1186/s13063-016-1574-z.
Non-invasive ventilation (NIV) tolerance is a key factor of NIV success. Hence, numerous sedative pharmacological or non-pharmacological strategies have been assessed to improve NIV tolerance. Music therapy in various health care settings has shown beneficial effects. In invasively ventilated critical care patients, encouraging results of music therapy on physiological parameters, anxiety, and agitation have been reported. We hypothesize that a musical intervention improves NIV tolerance in comparison to conventional care. We therefore question the potential benefit of a receptive music session administered to patients by trained caregivers ("musical intervention") to enhance acceptance and tolerance of NIV.
METHODS/DESIGN: We conduct a prospective, three-center, open-label, three-arm randomized trial involving patients in the intensive care unit (ICU) who require NIV, as assessed by the treating physician. Participants are allocated to a "musical intervention" arm ("musical intervention" applied during all NIV sessions), to a "sensory deprivation" arm (sight and hearing isolation during all NIV sessions), or to the control group. The primary endpoint is the change in respiratory comfort (measured with a digital visual scale) before the initiation and after 30 minutes of the first NIV session. The evaluation of the primary endpoint is performed blindly from the treatment group. Secondary endpoints include changes in respiratory and cardiovascular parameters during NIV sessions, the percentage of patients requiring endotracheal intubation, day-90 anxiety/depression and health-related quality of life, post-trauma stress induced by NIV, and the overall assessment of NIV. The follow-up for each participant is 90 days. We expect to randomize a total of 99 participants.
As music intervention is a simple and easy-to-implement non-pharmacological technique, efficacious in reducing anxiety in critically ill patients, it appeared logical to assess its efficacy in NIV, one of the most stressful techniques used in the ICU. Patient centeredness was crucial in choosing the outcomes assessed.
ClinicalTrials.gov: NCT02265458 . Registered on 25 August 2014.
无创通气（NIV）耐受性是NIV成功的关键因素。因此，人们评估了多种镇静药物或非药物策略来提高NIV耐受性。音乐疗法在各种医疗环境中均显示出有益效果。在接受有创通气的重症监护患者中，已有报道称音乐疗法对生理参数、焦虑和躁动有令人鼓舞的效果。我们假设与传统护理相比，音乐干预可提高NIV耐受性。因此，我们探讨由经过培训的护理人员为患者进行的接受性音乐治疗（“音乐干预”）对增强NIV接受度和耐受性的潜在益处。
方法/设计：我们开展一项前瞻性、三中心、开放标签、三臂随机试验，纳入重症监护病房（ICU）中经主治医生评估需要NIV的患者。参与者被分配至“音乐干预”组（在所有NIV治疗期间进行“音乐干预”）、“感觉剥夺”组（在所有NIV治疗期间进行视觉和听觉隔离）或对照组。主要终点是首次NIV治疗开始前和30分钟后呼吸舒适度的变化（用数字视觉量表测量）。对主要终点的评估在不知治疗组情况的条件下进行。次要终点包括NIV治疗期间呼吸和心血管参数的变化、需要气管插管的患者百分比、第90天的焦虑/抑郁及健康相关生活质量、NIV诱发的创伤后应激以及对NIV的总体评估。每位参与者的随访时间为90天。我们预计共随机分配99名参与者。
由于音乐干预是一种简单且易于实施的非药物技术，对降低重症患者的焦虑有效，因此评估其在NIV（ICU中使用的压力最大的技术之一）中的疗效似乎是合理的。以患者为中心对于选择评估的结局至关重要。
ClinicalTrials.gov：NCT02265458。于2014年8月25日注册。
