The comparison between pulmonary rehabilitation with music therapy vs pulmonary rehabilitation alone in patients hospitalized because of asthma exacerbation
| ISRCTN | ISRCTN17240890 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17240890 |
| Secondary identifying numbers | K/ZDS/006156 |
- Submission date
- 08/01/2017
- Registration date
- 18/01/2017
- Last edited
- 17/06/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English Summary
Background and study aims
Asthma is a common long-term condition where the airways can become narrowed due to inflammation (swelling). Some of the symptoms are cough, wheezing and breathlessness. Studies on the quality of life in asthma patients have shown that symptoms depend not only on the severity and length of the disease, but also on the social and mental condition of the patient and their family. Strong emotions can be responsible for the worsening of asthma symptoms and therefore mental disorders like depression and stress can affect the patient’s treatment. Previous research shows the development of treatments accompanied by relaxation methods, including music therapy, can help improve mental wellbeing and physical symptoms in people with asthma. However, it can be difficult to measure how well these programs work. This study is looking at changes in cortisol (a hormone that is released when the body is under stress) levels after patients have taken part in a relaxing activity (music therapy). The aim of this study is to find out whether music therapy can help improve the physical symptoms and mental wellbeing of people suffering from asthma.
Who can participate?
Adult patients who are in hospital and have asthma.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive standard treatment. This involves working with a physiotherapist to help learn breathing techniques and how to clear their airways. Those in the second group receive standard treatment as well as music therapy. This involves listening to 30 minutes of relaxing music, prepared by music therapists, to help improve mental wellbeing once a day throughout their hospital stay. Treatment for all participants takes place until they are discharged from hospital (this may vary depending on the patient). From the start of the study until they are discharged from hospital, participants have their breathing assessed by the clinical team and the amount of oxygen in their blood measured using a finger probe. At the start of the study and then after the program has finished, participants provide blood samples which are tested for stress hormone levels and undergo assessments to see how well they are controlling their asthma.
What are the possible benefits and risks of participating?
Participants may benefit from receiving extra treatments and more in-depth monitoring of their condition. There are no major risks involved in participating but some participants may experience discomfort or bruising from blood tests.
Where is the study run from?
Jagiellonian University Medical College (Poland)
When is the study starting and how long is it expected to run for?
June 2016 to December 2019
Who is funding the study?
Jagiellonian University Medical College (Poland)
Who is the main contact?
Dr Agnieszka Sliwka
Contact information
Scientific
Ośrodek Alergii i Immunologii
Skawinska 8
Krakow
31-066
Poland
 ORCID ID |
0000-0002-1338-3819 |
|---|
Study information
| Study design | Double-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a participant information sheet (Polish only) |
| Scientific title | The comparison between pulmonary rehabilitation with music therapy vs pulmonary rehabilitation alone on respiratory drive, cortisol level and asthma control in patients hospitalized with asthma exacerbation |
| Study hypothesis | Music therapy as a complementary treatment with pulmonary rehabilitaion has a positive effect on respiratory drive, psychological state and asthma control in patients with asthma exacerbation. |
| Ethics approval(s) | Bioethics Committee of the Jagiellonian University, 28/04/2016, ref: 122.6120.75.2016 |
| Condition | Asthma |
| Intervention | Patients will be randomly assigned to two groups. Randomization will be done by one researcher using a computer program available at: www.randomizer.org. When new patient will be recruited a phone information about randomization's result will be given by the researcher. Experimental Group: Participants will achieve a standard pharmacological treatment together with respiratory physiotherapy and passive music therapy (30 minutes of relaxing music prepared by music therapists, emitted from mp3 via a headphones). Applied program of treatment and pulmonary rehabilitation will be carried out according to guidelines of GINA report and the American Association of Cardiovascular and Pulmonary Rehabilitation. Physiotherapy and music therapy will be delivered once daily during the hospitalization period. Physiotherapy will be adopted to the patient's condition and might include: airways clearance techniques, reeducation of breathing pattern, diaphragmatic breathing and techniques to reduce shortness of breath. Music therapy methodology is based on data available in the literature. The music repertoire was prepared on the base of results of the previous study examining music preferences of 80 patients with asthma. Control Group: The treatment program will be exactly the same with the exception of music therapy. Instead, music controls will be listening to radio broadcasts about popular-science and nature. In both groups the intervention takes place daily for the duration of their hospital stay. Participants in both groups are followed up before, during and after intervention. Before treatment the following are measured: respiratory drive, blood cortisol level, dyspnoe, asthma control using Asthma Control Test, Asthma Quality of Life Questionnaire, and Brief Music in Mood Regulation Scale. After treatment the respiratory drive, blood cortisol level, dyspnoe, asthma control are measured. During the participants entire hospital stay they will have their dyspnoe, mood and blood saturation level measured. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Respiratory drive will be measured using Spirometer Master Lab at baseline and post-intervention 2. Blood cortisol level will be measured by testing blood samples taken early in the morning at baseline and post-intervention 3. Dyspnoea will be measured using Modified 0–10 category-ratio Borg scale and Fifteen-Count Breathlessness Score daily until discharged; saturation will be measured using portable finger spirometer daily until discharge |
| Secondary outcome measures | 1. Asthma control will be measured using the Asthma Control Test at baseline and Asthma Quality of Life Questionnaire at baseline and post-intervention 2. General emotion regulation and musical engagement will be measured using the Brief Music in Mood Regulation Scale at baseline |
| Overall study start date | 01/06/2016 |
| Overall study end date | 31/12/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 80 |
| Total final enrolment | 65 |
| Participant inclusion criteria | 1. Hospitalized patients with asthma 2. Aged 18 years and over 3. Provision of informed consent |
| Participant exclusion criteria | 1. Contraindications to pulmonary rehabilitation 2. Severe phase of coronary heart disease 3. Severe pulmonary hypertension 4. Significant hepatic dysfunction 5. Severe cognitive impairment 6. Advanced cancer 7. Damage of auditory system 8. Other comorbidities |
| Recruitment start date | 01/10/2016 |
| Recruitment end date | 31/05/2019 |
Locations
Countries of recruitment
- Poland
Study participating centre
Skawinska 8
Krakow
31-066
Poland
Sponsor information
University/education
Świętej Anny 12
Kraków
31-008
Poland
"ROR" |
https://ror.org/03bqmcz70 |
|---|
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 31/12/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | A publication is planned in peer reviewed, indexed journal from area of allergology, asthma or complementary therapies at the end of 2019. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Magdalena Pieniazek (pieniazek.m@interia.pl) |
Editorial Notes
17/06/2019: The total final enrolment was added.
08/01/2019: The recruitment end date has been updated from 31/12/2018 to 31/05/2019.
07/03/2018: The following changes were made:
1. Recruitment end date changed from 01/12/2018 to 31/12/2018
2. Overall trial end date changed from 31/12/2018 to 31/12/2019
