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临床试验/NCT05168241
NCT05168241已完成不适用

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

Karadeniz Technical University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Modifiye Medical Research Council (mMMC) Dyspnea scale

研究概览

简要总结

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.

详细描述

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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研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

盲法说明

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Modifiye Medical Research Council (mMMC) Dyspnea scale

时间窗: 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.

次要结局

  • COPD Assessment Test (CAT)(10 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

ELİF OKUR

PhD

Karadeniz Technical University

研究点 (2)

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