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Completed

NCT Number: NCT05168241

The Effect of Singing or Playing Melodica in COPD 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karadeniz Technical University

Trabzon, 61080, Turkey (Türkiye)

About this study

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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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: singing or playing melodica

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.

Other names: Education according to Pender's health promotion model

Primary outcomes

  1. 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.

Secondary outcomes

  1. COPD Assessment Test (CAT)

    Time frame: 10 weeks

    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.

Other outcomes

  1. six minutes walking tests

    Time frame: 10 weeks

    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.

  2. COPD Self-Efficacy Scale

    Time frame: 10 weeks

    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.

  3. Hospital Anxiety Depression (HAD) Scale

    Time frame: 10 weeks

    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.

Sponsors and collaborators

Lead sponsor

Karadeniz Technical University

Other

Registry information

Official study title

The Effect of Singing or Playing Melodica on Disease Symptoms, Self-Efficacy Level and Exercise Capacity in Chronic Obstructive Pulmonary Patients

Acronym: COPD

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 23, 2021
Registry last updated
Dec 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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