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临床试验/NCT05980845
NCT05980845已完成不适用

The Effect of Nature Sounds and Music on Vital Signs and Anxiety Levels of Hemodialysis Patients

Mehmet Akif Ersoy University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年9月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
2
主要终点
State Anxiety Scale (SAS)

研究概览

简要总结

The study was conducted as a randomized controlled experimental research to examine the effect of nature sounds and music on vital signs and anxiety levels of hemodialysis patients.

The study was conducted between September 6, 2019 and March 21, 2020 with 75 patients who received treatment in the hemodialysis units of three hospitals, one university, one education research and one state hospital in Antalya province, met the inclusion criteria and consented to participate in the study. Patients were homogenously divided into intervention (nature sound group n=25 and music group n=25) and control (n=25) groups on the basis of age, gender and hemodialysis duration. Patients in the intervention group were subjected to nature sounds/music during the hemodialysis procedure, while patients in the control group were not subjected to any intervention during the procedure. The data were collected by face-to-face interview technique using the "Descriptive Characteristics Form", "Vital Signs Monitoring Form", "State Anxiety Inventory" and "Trait Anxiety Inventory". Ethics committee approval, institutional permissions and written consent of the patients were obtained for the implementation of the study. Number, percentage, mean, standard deviation, minimum and maximum, the the Shapiro Wilk normality test, One-Way Analysis of Variance, Chi-Square tests, the Kruskal Wallis test, Dunn-Bonferroni test, Tukey HSD, Three-Way Analysis of Variance and Bonferroni Corrected Two Ratio Z test were employed in the evaluation of the data.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Volunteering to participate in the study
  • Age range between 18 and 79,
  • Receiving HD treatment for at least six months,
  • Receiving three sessions of HD treatment per week on a regular outpatient basis at the same institution.

排除标准

  • Any problem that prevents cognitive, affective and verbal communication,
  • Having any psychiatric condition,
  • Use of anxiolytic medication,
  • Out of the criteria for inclusion in the study,

结局指标

主要结局

State Anxiety Scale (SAS)

时间窗: Change in anxiety score during Nature Sounds and Music, an average of 10 minutes

State Anxiety Scale (SAS) is used to determine how an individual feels at a certain moment and under certain conditions. According to the degree of severity of the emotions, thoughts or behaviors expressed by the items, "not at all" (1), "a little" (2), "a lot" (3), "completely" (4) in the scale. Some of the items in the scale are direct statements and some of them are reversed statements.

The Trait Anxiety Scale (TAS)

时间窗: Change in anxiety score during Nature Sounds and Music, an average of 10 minutes

The Trait Anxiety Scale (TAS) is used to determine how the individual usually perceives themselves. The items are scored as "almost never" (1), "sometimes" (2), "very often" (3) and "almost always" (4) according to the frequency of the feelings, thoughts or behaviors expressed by the items. The items in the scale are in the form of direct and inverted statements.

次要结局

未报告次要终点

研究者

发起方
Mehmet Akif Ersoy University
申办方类型
Other
责任方
Principal Investigator
主要研究者

IMarasli

Principal Investigator

Mehmet Akif Ersoy University

研究点 (2)

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