The Effect of Singing or Playing Melodica in COPD Patients

NCT05168241 | Completed

• 1 other identifier: EOKUR
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; health promotion; musical instrument; singing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• COPD Assessment Test (CAT)

  10 weeks

Other Outcomes (3)

• six minutes walking tests

  10 weeks

• COPD Self-Efficacy Scale

  10 weeks

• Hospital Anxiety Depression (HAD) Scale

  10 weeks

Study Arms (2)

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.

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.

Other: control group

Interventions

song/melodica group OTHER

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.

Also known as: singing or playing melodica

1.the song/melodica group

control group OTHER

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.

Also known as: Education according to Pender's health promotion model

2. the control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karadeniz Technical University: lead

Study Sites (1)

Karadeniz Technical University

Trabzon, 61080, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 26522499 BACKGROUND

• 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.

  PMID: 23258783 BACKGROUND

• 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.

  PMID: 12091180 BACKGROUND

• 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.

  PMID: 2019177 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Singing; Control Groups

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phonation; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Elif OKUR

  Karadeniz Technical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: While taking informed consent, the purpose and content of the study were explained to the participants.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: 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).

Study Record Dates

• First Submitted: November 26, 2021
• First Posted: December 23, 2021
• Study Start: September 1, 2020
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: December 23, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)