The Effect of Singing or Playing Melodica in COPD Patients (COPD)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Other: song/melodica group; Other: control group

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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• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Trabzon, Turkey, 61080
    • Karadeniz Technical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1.the song/melodica group; 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.	Other: song/melodica group; 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.; Other Names: singing or playing melodica
Other: 2. the control group; 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.	Other: control group; 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.; Other Names: Education according to Pender's health promotion model

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
six minutes walking tests	The 6-minute walking distances 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.	10 weeks
COPD Self-Efficacy Scale	COPD Self-Efficacy Scale scores were recorded in the pre-test and post-test. A minimum of 34 points and a maximum of 170 points can be obtained from the scale as a total score. Minimum, maximum, median and mean values were evaluated for each group and compared between groups.	10 weeks
Hospital Anxiety Depression (HAD) Scale	Hospital Anxiety Depression (HAD) Scale scores were recorded in the pre-test and post-test.The answers are evaluated in a four-point Likert format and are scored between zero and three. The lowest score that can be obtained from both subscales is 0, and the highest score is 21. Minimum, maximum, median and mean values were evaluated for each group and compared between groups.	10 weeks

Collaborators and Investigators

• Sponsor: Karadeniz Technical University
• Investigators: Principal Investigator: Elif OKUR, Karadeniz Technical University

Publications and helpful links

General Publications

• 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. Erratum In: Am J Respir Crit Care Med. 2016 May 15;193(10):1185.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): August 31, 2021
• Study Completion (Actual): August 31, 2021

Study Registration Dates

• First Submitted: November 26, 2021
• First Submitted That Met QC Criteria: December 22, 2021
• First Posted (Actual): December 23, 2021

Study Record Updates

• Last Update Posted (Actual): December 23, 2021
• Last Update Submitted That Met QC Criteria: December 22, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: COPD; health promotion; singing; musical instrument
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: EOKUR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: I don't want to share my individual participant data with other participants because I haven't published my work yet.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No