Back to resultsThe Effect of Singing or Playing Melodica in COPD Patients (COPD)
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
song/melodica group
control group
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, health promotion, musical instrument, singing
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.
Sites / Locations
- Karadeniz Technical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
1.the song/melodica group
2. the control group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05168241
First Posted
November 26, 2021
Last Updated
December 22, 2021
Sponsor
Karadeniz Technical University
1. Study Identification
Unique Protocol Identification Number
NCT05168241
Brief Title
The Effect of Singing or Playing Melodica in COPD Patients
Acronym
COPD
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
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
August 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karadeniz Technical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, health promotion, musical instrument, singing
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
None (Open Label)
Masking Description
While taking informed consent, the purpose and content of the study were explained to the participants.
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1.the song/melodica group
Arm Type
Experimental
Arm Description
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.
Arm Title
2. the control group
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
song/melodica group
Other Intervention Name(s)
singing or playing melodica
Intervention Description
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
Intervention Name(s)
control group
Other Intervention Name(s)
Education according to Pender's health promotion model
Intervention Description
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.
Primary Outcome Measure Information:
Title
Modifiye Medical Research Council (mMMC) Dyspnea scale
Description
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.
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
COPD Assessment Test (CAT)
Description
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.
Time Frame
10 weeks
Other Pre-specified Outcome Measures:
Title
six minutes walking tests
Description
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.
Time Frame
10 weeks
Title
COPD Self-Efficacy Scale
Description
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.
Time Frame
10 weeks
Title
Hospital Anxiety Depression (HAD) Scale
Description
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.
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elif OKUR
Organizational Affiliation
Karadeniz Technical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karadeniz Technical University
City
Trabzon
ZIP/Postal Code
61080
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
I don't want to share my individual participant data with other participants because I haven't published my work yet.
Citations:
PubMed Identifier
26522499
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.
Results Reference
background
PubMed Identifier
23258783
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.
Results Reference
background
PubMed Identifier
12091180
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. Erratum In: Am J Respir Crit Care Med. 2016 May 15;193(10):1185.
Results Reference
background
PubMed Identifier
2019177
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.
Results Reference
background
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The Effect of Singing or Playing Melodica in COPD Patients
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