跳至主要内容
临床试验/NCT05219292
NCT05219292已完成不适用

Impact of a Multidisciplinary Protocol of Respiratory Kinesitherapy and Active Music Therapy on Anxiety, Depression and Pain in Lung Transplant Patients: PPKRMA

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2022年3月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
43
试验地点
1
主要终点
Evolution of anxiety

研究概览

简要总结

Transplantation remains the last resort to prolong life when the patient reaches the stage of terminal respiratory failure. Lung transplantation improves survival and quality of life compared to medical treatment, at acceptable costs. However, the burden of the lived reality and the direct consequences of the operation have considerable impact. The transplant patient faces extraordinary physical and psychological challenges.

While quality of life and long-term prognosis are significantly improved, psychopathological disorders are common, mainly anxiety disorders. A high prevalence of psychopathological disorders is reported in most retrospective and prospective studies. These are essentially adjustment disorders, with depressive mood and/or anxiety, reactive to the severity of the pre- and postoperative somatic reality.

The partial or total replacement of the respiratory "bellows" leads to more anxiety disorders than in other transplants. Quality of life is a multidimensional concept that encompasses medical, social, cultural, psychological and economic factors. It is based on four dimensions: physical state, somatic sensations, psychological state, social status. Regarding the quality of psychic evolution after transplantation, among the criteria that are usually analysed we find adaptation to body changes and anxiety management.

Meta-analyses of clinical trials have shown that music therapy, which is based on the use of the properties of music and sound for therapeutic purposes, has an impact on the human being, reducing anxiety, depression and pain. Two clinical trials have shown that pulmonary rehabilitation with active music therapy improves lung function and reduces dyspnoea. The concept of active music therapy, which emphasises sound production and improvisation, is a controlled technique of musical practice for therapeutic purposes. Playing a wind instrument, using vocal techniques and respiratory rhythm modulation techniques, would provide additional benefits for respiratory function.

The use of recorders as an oscillating exhalation resistance device will provide conditions similar to the treatment provided by a flutter, a device that creates exhalation resistance and improves secretion clearance.

Investigators hypothesize that the combination of Respiratory Kinesitherapy and active breath music therapy (PPKRMA) will address anxiety, depression, and pain in lung.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

入选标准

  • Patient aged at least 18 years and less than 70 years.
  • Patient who has had a lung transplant for less than 5 weeks and who has been transferred to the participating department that provides post-transplant follow-up.
  • Patient who has completed the pre-transplant assessment according to the practices of the receiving department.
  • Clinically stable as judged by the investigator (pulmonologist).
  • Patient who has been informed of the study and has given his agreement to participate.

排除标准

  • Impaired perception of music as judged by the investigator: musicogenic epilepsy (i.e. seizures provoked by music), hyperacusis (i.e. an abnormally low threshold of tolerance to noise), dysmusia (music is perceived as an annoying noise), amusia (rhythm, melody, chords of music are not perceived) .
  • Physical inability to perform the PPKRMA.
  • Neurocognitive disorders that do not allow the PPKRMA, the questionnaires required by the protocol or the functional explorations to be carried out.
  • Dependence on oxygen therapy with a flow rate of more than 5l of O
  • Persons deprived of liberty by judicial or administrative decision
  • Persons subject to psychiatric care
  • Persons admitted to a health or social institution for purposes other than research
  • Persons of full age subject to a legal protection measure (guardianship, curatorship).
  • Subjects participating in other interventional research with an exclusion period still in progress at pre-inclusion or which may interfere with the results of this research protocol.

结局指标

主要结局

Evolution of anxiety

时间窗: 28 days

Evolution of anxiety with the HAD (Hospital Anxiety and Depression) scale scores between the beginning and the end of the treatment in the rehabilitation service.

Evolution of pain

时间窗: 28 days

Evolution of pain with the visual analogue scale (VAS) scores between the beginning and the end of the treatment in the rehabilitation service

Evolution of depression

时间窗: 28 days

Evolution of depression with the HAD (Hospital Anxiety and Depression) scale) scores between the beginning and the end of the treatment in the rehabilitation service.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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