NCT05219292: PPKRMA

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

Completed Last updated 18 October 2024

What this trial tests

trial testing Active music therapy in Lung Transplant; Pain in 43 participants. Completed in 20 August 2024.

Timeline

22 March 2022

Primary endpoint
20 June 2024

20 August 2024

Quick facts

Lead sponsor	Hospices Civils de Lyon
Status	Completed
Study type	OBSERVATIONAL
Enrollment	43
Start date	22 March 2022
Primary completion	20 June 2024
Estimated completion	20 August 2024
Sites	1 location across France

Drugs / interventions tested

• Active music therapy
• Questionnaires

Conditions studied

• Lung Transplant; Pain — all drugs for Lung Transplant; Pain →

Sponsor

Hospices Civils de Lyon — full company profile →

Who can join

Adults 18 to 70, any sex, with Lung Transplant; Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.