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临床试验/NCT06953011
NCT06953011已完成不适用

The Effect of Preferred Music on Anxiety and Comfort Levels in Thyroidectomy Surgery: A Randomized Controlled Trial (RCT)

Dicle University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年3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
100
试验地点
1
主要终点
State-Trait Anxiety Scale

研究概览

简要总结

This study was conducted to investigate the effect preoperative music interventions on anxiety and postoperative comfort level in patients.

详细描述

Objective

This study was conducted to investigate the effect of preoperative music interventions on anxiety and postoperative comfort levels in patients.

Design: A randomized controlled quasi-experimental design was used. Methods: This study was conducted in the general surgery clinic of a university hospital in Diyarbakır, Turkey. A total of 100 patients (47 in the intervention and 53 in the control group) participated in the study by randomization. Personal Information Form, hemodynamic parameters, and State-Trait Anxiety Inventory were used for data collection. The State part of the State-Trait Anxiety Inventory was re-administered to the intervention group after the music intervention. In the postoperative period, hemodynamic parameters of all patients in both groups were monitoredş and the Perianesthesia Comfort Questionnaire was administered. SPSS 25.0 software was used for data analysis.

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 (Investigator)

盲法说明

Randomization was performed to ensure that patients who met the inclusion criteria among those admitted to the clinic for thyroidectomy surgery had an equal chance of being selected for the study. In order to perform randomized sampling, a table of random numbers was obtained over the internet in the computer environment by specifying the number of samples. A lottery method was then used to assign patients to either the intervention or control groups. To prevent mutual influence, patients were hospitalized in separate rooms.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Ages of 18-65,
  • •Hospitalized for 24 hours after surgery,
  • •without cognitive impairment
  • •consenting to participate

排除标准

  • •Individuals under the age of 18 and over the age of 65
  • •Individuals with cognitive impairment
  • •Individuals who declined to participate in the study

研究组 & 干预措施

music group

Experimental

Patients were met within 1 hour preoperatively. Vital signs, pain scores, and blood glucose levels were checked, and the state anxiety scale was administered. Music was played through headphones and speakers for at least 20 minutes, according to the patient's preference for both type and metod of listening. The state anxiety scale was then applied again. Patients' questions were answered and they were encouraged to share any concerns. Patient's questions were answered, and they were encouraged to share any concerns. They were prepared for surgery and transferred to the operating room. On the day after surgery, patients were visited again. Vital signs, pain scores, and blood glucose levels were checked and the perianesthesia comfort questionnaire (PCQ) was administered.

干预措施: music application (Other)

control group

No Intervention

Patients were met within 1 hour preoperatively. Vital signs, pain score, and blood glucose were checked, and state anxiety scale was administered. Patients' questions were answered, and they were encouraged to share any concerns. They were then prepared for surgery and transferred to the operating room. On the day after surgery, patients were visited again. Vital signs, pain scores, and blood glucose levels were checked, and the perianesthesia comfort questionnaire (PCQ) was administered.

结局指标

主要结局

State-Trait Anxiety Scale

时间窗: six months

This scale is grounded in the two-factor theory of anxiety and comprises two sections with a total of 40 items. The items include both direct statements, which reflect negative emotional states, and reverse statements, which reflect positive emotional states. The total score ranges from 20 to 80, with higher scores indicating greater levels of anxiety. The first section (Items 1-20) assesses state anxiety, evaluating how the individual feels at a given moment. Respondents are asked to select one of the following options: Not at all, A little, A lot, or Completely. The second section (Items 21-40) measures trait anxiety, reflecting how the individual generally feels over time. For each item, respondents choose from: Almost never, Sometimes, Very often, or Almost always. The scale is intended to measure anxiety experienced over the past six months.

次要结局

  • Perianesthesia Comfort Questionnaire (PCQ)(six months)

研究者

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

Çiçek SARUHAN

Lecturer

Dicle University

研究点 (1)

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