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临床试验/NCT07087899
NCT07087899已完成不适用

Romatoid Artritli Hastalarda Müziğin Semptom Yönetimi ve Yaşam Kalitesi Üzerine Etkisi

Irem Yildiz Cilengiroglu2 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2023年10月23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
发起方
入组人数
88
试验地点
2
主要终点
quality of life score

研究概览

简要总结

This randomized controlled study was designed to determine the effects of music on symptom management and quality of life in patients with rheumatoid arthritis.

The study was conducted between October 2023 and August 2024 with 88 patients diagnosed with rheumatoid arthritis (41 experimental, 47 control) at the Rheumatology clinic and outpatient clinic of a university hospital in Edirne. Within the scope of this study, the Turkish validity and reliability of the Patient Symptom Thermometer scale were tested. Data were collected using the "Patient Information Form" including sociodemographic and disease-related characteristics, the "EQ-5D General Quality of Life Scale," the "Patient Symptom Thermometer," and the "DAS-28 Disease Activity Score."

详细描述

Background and Aim: Rheumatoid arthritis is a chronic disease that significantly reduces quality of life due to both physical and psychosocial symptoms. Complementary methods such as music therapy are thought to be effective in alleviating symptoms and improving quality of life in patients with rheumatoid arthritis. This randomized controlled study was designed to determine the effects of music on symptom management and quality of life in patients with rheumatoid arthritis.

Material and Methods

The study was conducted between October 2023 and August 2024 with 88 patients diagnosed with rheumatoid arthritis (41 experimental, 47 control) at the Rheumatology clinic and outpatient clinic of a university hospital in Edirne. Within the scope of this study, the Turkish validity and reliability of the Patient Symptom Thermometer scale were tested. Data were collected using the "Patient Information Form" including sociodemographic and disease-related characteristics, the "EQ-5D General Quality of Life Scale," the "Patient Symptom Thermometer," and the "DAS-28 Disease Activity Score." During the first interview, the relevant scales and questionnaire were applied to patients in both the experimental and control groups. Patients in the experimental group were provided with music players and headphones to listen to music twice a day-once during the day and once at night-for one month. On the 15th and 30th days of the study, the EQ-5D General Quality of Life Scale and the Patient Symptom Thermometer were administered to the experimental group. The same scales were also applied to the control group, who did not listen to music, on the 15th and 30th days.

Financial Support: The present study was supported by the Research Fund of Trakya University. Project No: 2023/73

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients diagnosed with RA by a physician according to the American College of Rheumatology - The European Alliance of Associations for Rheumatology (ACR-EULAR) 2010 criteria
  • •Patients diagnosed with Rheumatoid Arthritis at least 6 months ago
  • •Patients with Rheumatoid Arthritis who volunteer to participate in the study

排除标准

  • •Patients with hearing problems
  • •Rheumatoid Arthritis patients who do not volunteer to participate in the study

研究组 & 干预措施

music

Experimental

The participants were informed about the research process during the first meeting. Participants were told that, if they agreed to participate in the study, they would need to listen to music twice a day-once during the day and once at night-for a period of one month. It was explained that each participant would be provided with a music player and headphones for one month, and that these items would need to be returned after the study ended. Participants were also given information on how to listen to the music. Participants were instructed on how to use the music player, informed that there were two playlists-one for daytime and one for nighttime-and advised to listen to each playlist for a maximum of 30 minutes.

干预措施: music (Other)

control

No Intervention

In the first interview, participants were informed about the research process. Patient information forms and scales (EQ-5D General Quality of Life Scale, DAS-28 Disease Activity Score and Patient Symptom Thermometer) that would be used in data collection were explained to the participants. Participants were informed about how often and how these forms and scales would be applied. No intervention was applied to the participants in the control group in the study.

结局指标

主要结局

quality of life score

时间窗: one month

Change in the mean scores of the EQ-5D General Quality of Life Scale of the patients at the first interview, on the 15th day and on the 30th day

Patient Symptom Thermometer scores

时间窗: one month

Change in mean Patient Symptom Thermometer scores of patients at the first visit, on the 15th day, and on the 30th day

quality of life score

时间窗: one month

Change in the mean scores of the EQ-5D General Quality of Life Scale of the patients at the first interview, on the 15th day and on the 30th day

Patient Symptom Thermometer scores

时间窗: one month

Change in mean Patient Symptom Thermometer scores of patients at the first visit, on the 15th day, and on the 30th day

次要结局

未报告次要终点

研究者

发起方
Irem Yildiz Cilengiroglu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Irem Yildiz Cilengiroglu

Research assistant

Trakya University

研究点 (2)

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