The Effect of Singing or Playing Melodica in COPD Patients

NCT ID: NCT05168241

Last Updated: 2021-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-08-31

Brief Summary

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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

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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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Conditions

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Chronic Obstructive Pulmonary Disease

Keywords

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COPD health promotion musical instrument singing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

While taking informed consent, the purpose and content of the study were explained to the participants.

Study Groups

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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.

Group Type EXPERIMENTAL

song/melodica group

Intervention Type 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.

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.

Group Type OTHER

control group

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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singing or playing melodica Education according to Pender's health promotion model

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karadeniz Technical University

OTHER

Sponsor Role lead

Responsible Party

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ELİF OKUR

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elif OKUR

Role: PRINCIPAL_INVESTIGATOR

Karadeniz Technical University

Locations

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Karadeniz Technical University

Trabzon, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 26522499 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23258783 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12091180 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2019177 (View on PubMed)

Other Identifiers

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EOKUR

Identifier Type: -

Identifier Source: org_study_id