Clinical trial NCT05168241: The Effect of Singing or Playing Melodica in COPD Patients
Official title: The Effect of Singing or Playing Melodica on Disease Symptoms, Self-Efficacy Level and Exercise Capacity in Chronic Obstructive Pulmonary Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
health promotion
musical instrument
singing
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
First posted: 2021-12-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

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Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:-

* 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.

Primary outcomes:
measure: Modifiye Medical Research Council (mMMC) Dyspnea scale
timeFrame: 10 weeks
Secondary outcomes:
measure: COPD Assessment Test (CAT)
timeFrame: 10 weeks
Other outcomes:
measure: six minutes walking tests
timeFrame: 10 weeks
measure: COPD Self-Efficacy Scale
timeFrame: 10 weeks
measure: Hospital Anxiety Depression (HAD) Scale
timeFrame: 10 weeks
Locations:
city: Trabzon
country: Turkey
facility: Karadeniz Technical University
Study officials:
affiliation: Karadeniz Technical University
name: Elif OKUR
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Jones 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.
citation: ATS 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.
citation: Wigal JK, Creer TL, Kotses H. The COPD Self-Efficacy Scale. Chest. 1991 May;99(5):1193-6. doi: 10.1378/chest.99.5.1193.