Chronic Obstructive Pulmonary DiseaseCOPDNCT05168241
The Effect of Singing or Playing Melodica in COPD Patients
A study testing song/melodica group in people with Chronic Obstructive Pulmonary Disease, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted as a randomized controlled experimental study to determine the effect of singing or playing melodica activity applied to chronic obstructive pulmonary patients on symptoms, self-efficacy level, and exercise capacity of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- song/melodica group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2020to 31 Aug 2021
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years and older,
- Having been diagnosed with COPD by the physician based on the results of the pulmonary function test taken with spirometry according to the GOLD criteria, who are in the stable period of COPD,
- Applying to thoracic polyclinics,
- not bedridden,
- Does not have vision and hearing problems that do not interfere with communication,
- Patients who can complete the six-minute walk test,
- Willing to sing and/or play melodica
- Patients who agreed to participate in the study and who read and signed the informed consent form were included in the sample.
Who cannot join
- Those who do not agree to participate in the research,
- with asthma,
- with a diagnosis of cancer,
- with a diagnosis of Covid-19,
- Having unstable angina or myocardial infarction in the last 1 month,
- Having a resting heart rate >120/min,
- Patients with a resting systolic blood pressure of >180 mmHg and a diastolic blood pressure of >100 mmHg (183) were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Singing or Playing Melodica on Disease Symptoms, Self-Efficacy Level and Exercise Capacity in Chronic Obstructive Pulmonary Patients
This study was conducted as a randomized controlled experimental study to determine the effect of singing or playing melodica activity applied to chronic obstructive pulmonary patients on symptoms, self-efficacy level, and exercise capacity of patients.
Read the detailed description
The research was carried out in the chest diseases polyclinics of a hospital in Trabzon city center between September 2020 and August 2021 with 30 patients: 15 in the control group and 15 in the song/melodica group. Based on Pender's health promotion model, the control group received training and counseling for ten weeks, including face-toface training and telephone follow-up. According to Pender's health promotion model, patients in the song/melodica group were given face-to-face training once, singing/playing the melodica training twice, and counseling and follow-up over the phone twice, with 15- day intervals. The data were collected with a patient information form and scales examining disease symptoms, self-efficacy, and exercise capacity. To evaluate the data, ttest, Mann-Whitney U, ANOVA, Kruskal Wallis test were used for independent groups to evaluate changes over time, and paired two-sample t-test, Wilcoxon test, and ANOVA test were used in repetitive measurements for dependent groups.
.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- song/melodica group, control group
- Keywords
- COPD, health promotion, musical instrument, singing
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
song/melodica groupOther
Also called singing or playing melodica
The patients who were divided into groups according to their wishes to sing or play the melodica were given warm-up training before the song group (20 min. warm-up training including breathing exercises, 20 min. singing) and melodica group (20 min. breathing). warm-up training including exercises, playing melodica for 20 minutes) was given with the researcher under the leadership of an experienced music teacher.
For two weeks, a total of 40 minutes of song/melodica training was given per week. The singing group was given an assignment to sing for at least 20 minutes a day and the melodica playing group to play the melodica for at least 20 minutes a day. The patients were asked to do their song/melodica homework for at least 20-30 minutes a day, and then they were told about the follow-up papers.
Patients in the song/melody group were followed up by telephone twice a total of 15 days at the 5th and 7th weeks.
control groupOther
Also called Education according to Pender's health promotion model
In the first interview, the pre-tests were applied by the researcher with the face-to-face interview technique. Afterwards, nursing education was given through the training guide prepared according to Pender's health promotion model. The control group was followed up and counseled by phone, twice a day, twice a day, in the 5th and 7th weeks.
Post-tests were applied at week 10 to evaluate the effectiveness of the interventions.
| Study group | Role | What they receive |
|---|---|---|
| 1.the song/melodica group | Experimental | 15 patients in the song/melodica group. Pre-tests were applied to the song/melodica group in the first interview, and training was given according to Pender's Health Promotion Model. In addition to the trainings, the experimental group was given a total of 40 minutes twice a day, a total of 2 sessions, melodica training for the melodica group, and song activity for the singing group. In addition, the song/melodica group was encouraged to work at home for at least 20 minutes every day by providing the necessary motivation for singing or playing the melodica. The patient was asked to record his practices by keeping a diary.
Two follow-ups were made by phone every 15 days, and the final tests were done face-to-face after 15 days. It tooks 10 weeks in total. Receives: Other: song/melodica group |
| 2. the control group | Other | 15 patients in the control group. The control group was given pre-tests in the first interview, they were trained according to Pender's Health Promotion Model, they were followed up twice every 15 days by phone, and the post-tests were done face-to-face after 15 days, It tooks 10 weeks in total. Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modifiye Medical Research Council (mMMC) Dyspnea scale
Dyspnea scores of the patients were recorded in the pre-test and post-test.The Medical Research Council Scale (mMRC) consists of five items based on various physical activities that cause dyspnea.
On this scale, patients are asked to simply select the activity that produces the feeling of dyspnea. Scoring is between 0-4. Minimum, maximum, median and mean values were evaluated for each group and compared between groups.
Measured: 10 weeks
Secondary outcomes (1)
COPD Assessment Test (CAT)
The CAT scale, which rates the effects of chronic obstructive pulmonary disease on the patient and deterioration in health, consists of eight parameters that question "cough, sputum, chest symptoms, fatigue, and confidence in leaving home".
The score that can be obtained from the scale is a minimum of 0 and a maximum of 40 points. CAT scores of the patients were recorded in the pre-test and post-test. Minimum, maximum, median and mean values were evaluated for each group and compared between groups.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2021
- Study start1 Sep 2020
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Power analysis was used to calculate the sample size of the study. The power of the test was calculated with the G\*Power 3.1 program. The effect size was calculated as 1.24 according to the study of Canga et al., which was a similar study that was taken as a reference during the calculation process (28). The sample consisted of a total of 30 patients, 15 of whom were control and 15 were song/melodica, determined by power analysis at 95% confidence interval, 5% significance level and 1.24 effect size (df=28; t=1.701).
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ELİF OKUR, Karadeniz Technical University
- Investigators
- Elif OKUR, Principal investigator, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05168241
- Sponsor's protocol ID
- EOKUR
- Acronym
- COPD
- Status last verified
- Nov 2021
- First submitted
- 26 Nov 2021
- Last updated
- 23 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I don't want to share my individual participant data with other participants because I haven't published my work yet.
Publications
Canga B, Azoulay R, Raskin J, Loewy J. AIR: Advances in Respiration - Music therapy in the treatment of chronic pulmonary disease. Respir Med. 2015 Dec;109(12):1532-9. doi: 10.1016/j.rmed.2015.10.001. Epub 2015 Oct 19.
PubMed 26522499Jones PW, Adamek L, Nadeau G, Banik N. Comparisons of health status scores with MRC grades in COPD: implications for the GOLD 2011 classification. Eur Respir J. 2013 Sep;42(3):647-54. doi: 10.1183/09031936.00125612. Epub 2012 Dec 20.
PubMed 23258783ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.
PubMed 12091180Wigal JK, Creer TL, Kotses H. The COPD Self-Efficacy Scale. Chest. 1991 May;99(5):1193-6. doi: 10.1378/chest.99.5.1193.
PubMed 2019177
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Singing or Playing Melodica on Disease Symptoms, Self-Efficacy Level and Exercise Capacity in Chronic Obstructive Pulmonary Patients
- ClinicalTrials.gov ID
- NCT05168241
- Acronym / sponsor ID
- COPD / EOKUR
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, health promotion, musical instrument, singing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 23 Dec 2021 (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.
This study was conducted as a randomized controlled experimental study to determine the effect of singing or playing melodica activity applied to chronic obstructive pulmonary patients on symptoms, self-efficacy level, and exercise capacity of patients.
Detailed description
The research was carried out in the chest diseases polyclinics of a hospital in Trabzon city center between September 2020 and August 2021 with 30 patients: 15 in the control group and 15 in the song/melodica group. Based on Pender's health promotion model, the control group received training and counseling for ten weeks, including face-toface training and telephone follow-up. According to Pender's health promotion model, patients in the song/melodica group were given face-to-face training once, singing/playing the melodica training twice, and counseling and follow-up over the phone twice, with 15- day intervals. The data were collected with a patient information form and scales examining disease symptoms, self-efficacy, and exercise capacity. To evaluate the data, ttest, Mann-Whitney U, ANOVA, Kruskal Wallis test were used for independent groups to evaluate changes over time, and paired two-sample t-test, Wilcoxon test, and ANOVA test were used in repetitive measurements for dependent groups.
.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Power analysis was used to calculate the sample size of the study. The power of the test was calculated with the G*Power 3.1 program. The effect size was calculated as 1.24 according to the study of Canga et al., which was a similar study that was taken as a reference during the calculation process (28). The sample consisted of a total of 30 patients, 15 of whom were control and 15 were song/melodica, determined by power analysis at 95% confidence interval, 5% significance level and 1.24 effect size (df=28; t=1.701).
| Arm | Type | Receives |
|---|---|---|
| 1.the song/melodica group | Experimental | Other: song/melodica group15 patients in the song/melodica group. Pre-tests were applied to the song/melodica group in the first interview, and training was given according to Pender's Health Promotion Model. In addition to the trainings, the experimental group was given a total of 40 minutes twice a day, a total of 2 sessions, melodica training for the melodica group, and song activity for the singing group. In addition, the song/melodica group was encouraged to work at home for at least 20 minutes every day by providing the necessary motivation for singing or playing the melodica. The patient was asked to record his practices by keeping a diary. Two follow-ups were made by phone every 15 days, and the final tests were done face-to-face after 15 days. It tooks 10 weeks in total. |
| 2. the control group | Other | Other: control group15 patients in the control group. The control group was given pre-tests in the first interview, they were trained according to Pender's Health Promotion Model, they were followed up twice every 15 days by phone, and the post-tests were done face-to-face after 15 days, It tooks 10 weeks in total. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years and older,
- Having been diagnosed with COPD by the physician based on the results of the pulmonary function test taken with spirometry according to the GOLD criteria, who are in the stable period of COPD,
- Applying to thoracic polyclinics,
- not bedridden,
- Does not have vision and hearing problems that do not interfere with communication,
Key exclusion criteria (7 listed)
- Those who do not agree to participate in the research,
- with asthma,
- with a diagnosis of cancer,
- with a diagnosis of Covid-19,
- Having unstable angina or myocardial infarction in the last 1 month,
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 |
|---|---|---|
| song/melodica groupAlso: singing or playing melodicaThe patients who were divided into groups according to their wishes to sing or play the melodica were given warm-up training before the song group (20 min. warm-up training including breathing exercises, 20 min. singing) and melodica group (20 min. breathing). warm-up training including exercises, playing melodica for 20 minutes) was given with the researcher under the leadership of an experienced music teacher. For two weeks, a total of 40 minutes of song/melodica training was given per week. The singing group was given an assignment to sing for at least 20 minutes a day and the melodica playing group to play the melodica for at least 20 minutes a day. The patients were asked to do their song/melodica homework for at least 20-30 minutes a day, and then they were told about the follow-up papers. Patients in the song/melody group were followed up by telephone twice a total of 15 days at the 5th and 7th weeks. | Other | 1.the song/melodica group |
| control groupAlso: Education according to Pender's health promotion modelIn the first interview, the pre-tests were applied by the researcher with the face-to-face interview technique. Afterwards, nursing education was given through the training guide prepared according to Pender's health promotion model. The control group was followed up and counseled by phone, twice a day, twice a day, in the 5th and 7th weeks. Post-tests were applied at week 10 to evaluate the effectiveness of the interventions. | Other | 2. the control group |
Primary outcome
Modifiye Medical Research Council (mMMC) Dyspnea scale
Time frame: 10 weeks
Dyspnea scores of the patients were recorded in the pre-test and post-test.The Medical Research Council Scale (mMRC) consists of five items based on various physical activities that cause dyspnea. On this scale, patients are asked to simply select the activity that produces the feeling of dyspnea. Scoring is between 0-4. Minimum, maximum, median and mean values were evaluated for each group and compared between groups.
1 secondary outcome
COPD Assessment Test (CAT)
Time frame: 10 weeks
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 23 Dec 2021.
- Background: PubMed 26522499Canga B, Azoulay R, Raskin J, Loewy J. AIR: Advances in Respiration - Music therapy in the treatment of chronic pulmonary disease. Respir Med. 2015 Dec;109(12):1532-9. doi: 10.1016/j.rmed.2015.10.001. Epub 2015 Oct 19.
- Background: PubMed 23258783Jones PW, Adamek L, Nadeau G, Banik N. Comparisons of health status scores with MRC grades in COPD: implications for the GOLD 2011 classification. Eur Respir J. 2013 Sep;42(3):647-54. doi: 10.1183/09031936.00125612. Epub 2012 Dec 20.
- Background: PubMed 12091180ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.
- Background: PubMed 2019177Wigal JK, Creer TL, Kotses H. The COPD Self-Efficacy Scale. Chest. 1991 May;99(5):1193-6. doi: 10.1378/chest.99.5.1193.
- Individual participant dataSharing planned: No. I don't want to share my individual participant data with other participants because I haven't published my work yet.
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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.
Elif OKUR principal investigator
Karadeniz Technical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing song/melodica group in people with Chronic Obstructive Pulmonary Disease, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
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 8 inclusion and 7 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 23 Dec 2021. 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 Turkey (Türkiye). 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?
Modifiye Medical Research Council (mMMC) Dyspnea scale (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05168241, which also lists 4 linked publications.
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 23 Dec 2021; AzTrials last refreshed its copy on 7 Nov 2026.