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临床试验/NCT06865729
NCT06865729已完成不适用

Effect of Music Therapy Applied to Hospitalized Chronically Ill Individuals on Hospital Anxiety, Depression and Comfort Levels: A Randomized Controlled Trial

Amasya University1 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2024年9月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
59
试验地点
1
主要终点
Hospital Anxiety and Depression Scale (HADS)

研究概览

简要总结

Aim: It has been determined that there are limited studies in our country where music is used as a nursing intervention and the effects of music therapy on the psychological symptoms and comfort levels of individuals with chronic diseases are evaluated. This study will be conducted to determine the effects of music therapy applied to hospitalized individuals with chronic diseases on hospital anxiety, depression and comfort levels.

The research will be conducted at the Urology Department of Merzifon Kara Mustafa Paşa State Hospital between September 2024 and May 2025. The research is a randomized controlled experimental type. The sample of the research will consist of 60 participants, 30 in the music therapy group and 30 in the control group, who are 18 years of age and older and diagnosed with chronic diseases.

Data in the research: The research data will be collected using the Personal Information Form, Hospital Anxiety and Depression Scale and General Comfort Scale Short Form.

In this study, music therapy will be performed by the researchers for 4 days (the average length of stay of inpatients is 4 days), starting from the first day the participants start their inpatient treatment in the hospital. The data collection forms will be applied twice in total, at the first interview (pre-test) and on the morning of the 5th day (post-test).

详细描述

It has been determined that anxiety and depression in individuals with chronic diseases are strongly and independently associated with mental health and physical symptom burden, and depression also has an important relationship with quality of life areas. Anxiety and depression negatively affect the continuation of treatment, its effectiveness and the quality of life of individuals in chronic diseases. All these negative situations experienced by patients also cause a decrease in comfort. Elimination or reduction of situations that disturb patients is only possible by increasing comfort. It is known that patients with a high level of comfort recover more quickly and can cope with the disease process more easily.

Various pharmacological treatments are applied to alleviate the anxiety and depression levels in individuals with chronic diseases, and these treatments have important side effects that affect the body and mind. For this reason, the use of non-pharmacological treatments such as cognitive behavioral therapy, physical activity, group therapies, relaxation and dreaming methods, aromatherapy, laughter therapy and hypnosis has become privileged in overcoming depression and anxiety in individuals with chronic diseases. Music therapy is another non-pharmacological treatment frequently used to relieve depression and anxiety.

Data analysis: The data obtained from the research will be analyzed in the Statistical Package for Social Science (SPSS) 21 statistical program. Variables covering the introductory characteristics of individuals with chronic diseases will be expressed as numbers and percentages. The Shapiro-Wilk test will determine whether the data show a normal distribution and parametric and/or non-parametric tests will be used according to the results obtained. Statistical significance will be accepted as p<.05.

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

入排标准

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

入选标准

  • •Being over 18 years of age
  • •Being hospitalized due to a chronic disease
  • •Speaking and understanding Turkish
  • •Not using any medication that would affect anxiety and depression
  • •Giving consent to participate in the study

排除标准

  • •Having been diagnosed with any psychiatric/neurological disease
  • •Having problems with sensory perception and communication skills

研究组 & 干预措施

Participant Group

Experimental

Music Therapy

干预措施: Music therapy (Behavioral)

Control Group

No Intervention

Control Group

结局指标

主要结局

Hospital Anxiety and Depression Scale (HADS)

时间窗: A pre-test will be applied after the patients are admitted to the clinic. The post-test will be applied on the 5th day of the patients' hospitalization.

The scale was developed by Zigmond and Snaith (1983).The adaptation of the scale to Turkish and its validity and reliability analyses were conducted by Aydemir et al. in 1997.The scale consists of 14 items. Odd-numbered items investigate anxiety and even-numbered items investigate depression.The scale is a four-point Likert-type assessment tool and the scores of the items range from 0 to 3.However, each item is scored differently; items 1, 3, 5, 6, 8, 10, 11 and 13 show decreasing severity and are scored as 3, 2, 1, 0. On the other hand, items 2, 4, 7, 9, 12 and 14 are scored as 0, 1, 2, 3.The total scores of the subscales are obtained by summing the scores of these items.For the anxiety subscale, items 1, 3, 5, 7, 9, 11 and 13 are added; for the depression subscale, items 2, 4, 6, 8, 10, 12 and 14 are added.The cut-off point for the anxiety subscale of the Turkish form of the Hospital Anxiety and Depression Scale was found to be 10, and the cut-off point for the depression subscale.

Shortened General Comfort Questionnaire (SGCQ)

时间窗: A pre-test will be applied after the patients are admitted to the clinic. The post-test will be applied on the 5th day of the patients' hospitalization.

The scale was developed by Kolcaba in 2006. The Turkish validity and reliability study of the scale was conducted by Çıtlık Sarıtaş et al. (2018). The scale consists of 28 items and the items of the scale are scored between 28-168. The lowest possible value, 1, indicates low comfort, and the highest value, 6, indicates high comfort. The General Comfort Scale Short Form includes the sub-dimensions of Relief (9 items), Relaxation (9 items), and Superiority (10 items). The total score obtained is divided by the number of scale items to find the mean value. The Cronbach alpha reliability coefficient of the Turkish form of the scale was found to be 0.82. The Cronbach alpha reliability coefficients of the scale sub-dimensions (relief, relaxation, and superiority) were found to be 0.81, 0.81, and 0.76, respectively.

次要结局

未报告次要终点

研究者

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

Kübras

Master Student

Amasya University

研究点 (1)

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