Trials / Completed
CompletedNCT05219292
Impact of a Multidisciplinary Protocol of Respiratory Kinesitherapy and Active Music Therapy on Anxiety, Depression and Pain in Lung Transplant Patients
Impact of a Multidisciplinary Protocol of Respiratory Kinesitherapy and Active Music Therapy on Anxiety, Depression and Pain in Lung Transplant Patients: PPKRMA
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 43 (actual)
- Sponsor
- Hospices Civils de Lyon · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Active music therapy | Active music therapy is not a musical learning process. The restrictive character of classical respiratory rehabilitation will be alleviated by the playful aspect and the pleasure generated by the sessions, which will facilitate the commitment of the patients in their post-transplant respiratory rehabilitation. The recorder was chosen among other wind instruments for several reasons: * Its use is simple, * It acts as an oscillating exhalation resistance device that generates a positive expiratory pressure (auto-PEP) produced by this wind instrument allows to obtain conditions similar to the treatment performed by a flutter (classical respiratory rehabilitation), a pressure on the expiratory flow with the obtaining of an oscillating effect during the trills, an increase of the respiratory capacities, * The characteristics of the sound it produces (duration, intensity, timbre and frequency) will generate auditory feedback allowing patients to become aware of their breathing patterns. |
| OTHER | Questionnaires | We chose the HAD (Hospital Anxiety and Depression Scale) to assess anxiety and depression. This test is a reference test, often used in studies of transplant patients. The results obtained in previous studies allowed us to create our hypotheses. To measure pain we chose the visual analogue scale (VAS). This reference test is often used in pain studies. It has the advantage of being simple to perform and easy to understand. Quality of life will be assessed using the SF-12 (Short Form 12 Health Survey Questionary). We consider it to be simple and easy for patients to understand. |
Timeline
- Start date
- 2022-03-22
- Primary completion
- 2024-06-20
- Completion
- 2024-08-20
- First posted
- 2022-02-02
- Last updated
- 2024-10-18
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT05219292. Inclusion in this directory is not an endorsement.