Clinical trial NCT05219292: Impact of a Multidisciplinary Protocol of Respiratory Kinesitherapy and Active Music Therapy on Anxiety, Depression and Pain in Lung Transplant Patients
Official title: Impact of a Multidisciplinary Protocol of Respiratory Kinesitherapy and Active Music Therapy on Anxiety, Depression and Pain in Lung Transplant Patients: PPKRMA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Transplant; Pain
Keywords: Lung transplantation
Respiratory kinesitherapy
Active music therapy
Anxiety
Depression
Pain
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2022-02-02
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited during the pre-transplant assessment by the physiotherapist, the pneumologist and/or the transplant nurse coordinator. The patient has the hospital stay of the pre-transplantation to give his answer. The protocol starts on arrival in the rehabilitation department.

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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 O2.
* 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.

Primary outcomes:
measure: Evolution of anxiety
timeFrame: 28 days
measure: Evolution of depression
timeFrame: 28 days
measure: Evolution of pain
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Pneumologie C Bât A4 Hôpital cardiologique Louis Pradel, Groupement Hospitalier Est Hospices Civils de Lyon
Study officials:
References: