Lung Transplant; PainPPKRMANCT05219292
Impact of a Multidisciplinary Protocol of Respiratory Kinesitherapy and Active Music Therapy on Anxiety, Depression and Pain in Lung Transplant Patients
An observational study of Lung Transplant; Pain, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lung Transplant; Pain
- What is being tested?
- Active music therapy and Questionnaires
- How many people
- 43 participants
- Where
- 1 siteFrance
- Study dates
- 22 Mar 2022to 20 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Pneumologie C Bât A4 Hôpital cardiologique Louis Pradel, Groupement Hospitalier Est Hospices Civils de Lyon
Bron, 69500
About this study
Official title: Impact of a Multidisciplinary Protocol of Respiratory Kinesitherapy and Active Music Therapy on Anxiety, Depression and Pain in Lung Transplant Patients: PPKRMA
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.
Read more
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
- Lung Transplant; Pain
- Being tested
- Active music therapy, Questionnaires
- Keywords
- Lung transplantation, Respiratory kinesitherapy, Active music therapy, Anxiety, Depression, Pain
- Medical subject headings
- Pain, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active music therapyOther
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.
QuestionnairesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Adult patients followed for a recent lung transplant. | 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. Receives: Other: Active music therapy; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of anxiety
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.
Measured: 28 days
Evolution of depression
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.
Measured: 28 days
Evolution of pain
Evolution of pain with the visual analogue scale (VAS) scores between the beginning and the end of the treatment in the rehabilitation service
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start22 Mar 2022
- Primary completion20 Jun 2024
- Study completion20 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Transplant; PainStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05219292
- Sponsor's protocol ID
- 69HCL21_1061
- Other IDs
- 2022-A00056-37
- Acronym
- PPKRMA
- Status last verified
- Oct 2024
- First submitted
- 21 Jan 2022
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Multidisciplinary Protocol of Respiratory Kinesitherapy and Active Music Therapy on Anxiety, Depression and Pain in Lung Transplant Patients: PPKRMA
- ClinicalTrials.gov ID
- NCT05219292
- Acronym / sponsor ID
- PPKRMA / 69HCL21_1061
- Conditions
- Lung Transplant; Pain
- Keywords
- Lung transplantation, Respiratory kinesitherapy, Active music therapy, Anxiety, Depression, Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 20 Aug 2024 (actual)
- First posted
- 2 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients followed for a recent lung transplant. | – | Other: Active music therapy, Other: QuestionnairesPatients 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active music therapyActive 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 | Adult patients followed for a recent lung transplant. |
| QuestionnairesWe 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. | Other | Adult patients followed for a recent lung transplant. |
Primary outcome
Evolution of anxiety
Time frame: 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 depression
Time frame: 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.
Evolution of pain
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Transplant; Pain, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of anxiety (time frame: 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024; AzTrials last refreshed its copy on 7 Nov 2026.