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临床试验/NCT05329519
NCT05329519已完成不适用

The Effects of Listening Music During Breathing Exercises on Vital Sings and Pulmonary Functions After Video-assisted Thoracoscopic Surgery:A Randomized-controlled Study

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年6月15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
30
试验地点
1
主要终点
systolic blood pressure

研究概览

简要总结

Background and purpose : This study aims to analyze the effects of listening to music during deep breathing and coughing exercises on vital sings and pulmonary functions in patients, who underwent video assisted thoracoscopic surgery with wedge resection.

Materials and methods: This randomized and single-blinded study was conducted on 30 patients, including 15 patients in the music and the control groups. The patients were randomized into the music group, which listened to music during deep breathing and coughing exercises and the control group that only performed the exercises. Data were collected preoperatively and postoperatively. Patient information form, observation form and the visual analog scale were used for data collection.

详细描述

  1. Methods 2.1. Study design and setting This randomized trial was conducted at a research and training hospital in Ankara province of Turkey between June 2016 and January 2017.

2.2. Sample size Sample size was calculated with reference to the change in pain scores in a study of (music group: 29.7 ± 19.8, control group: 50.7±19.2). A total of 22 patients with 11 in each group were needed for Type I error of 0.05 and Type II error of 0.20. Given the possibility of withdrawals, study was intended to reach 30 patients with 15 in each group.

Since the patients in the control and intervention (music) groups could share their experiences before the surgery, randomized the patients weekly. With this aim, 'R Studio' software was used for block randomization to determine the groups that would receive the intervention on each week. The patients were single-blinded so that they were unaware of which group they had been assigned to.

Study included the voluntary patients age of 18 years and above the age of 18 years, who would undergo a video assisted thoracoscopic surgery with wedge resection, could read and write in Turkish, had no visual and auditory problems, and were categorized as ASA I, ASA II or ASA III patients according to the American Society of Anesthesiologists (ASA) physical status classification system. Patients with visual and auditory problems, who could not read or write in Turkish and priorly underwent a video assisted thoracoscopic surgery with wedge resection were excluded.

2.3. Tools Patient information form, observation from and the visual analog scale were used for data collection, which took place before the surgery and days 1, 2 and 3 postoperatively.

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 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Voluntary patients
  • •Age of 18 years and above the age of 18 years, who would undergo a video assisted thoracoscopic surgery with wedge resection,
  • •Patient could read and write in Turkish,
  • •Patient had no visual and auditory problems,
  • •Patient were categorized as ASA I, ASA II or ASA III patients according to the American Society of Anesthesiologists (ASA) physical status classification system.

排除标准

  • •Non-voluntary patients
  • •Under the age of 18 years
  • •Patients with visual and auditory problems, who could not read or write in Turkish
  • •Patients priorly underwent a VATS with wedge resection.

研究组 & 干预措施

Music group

Experimental

Patients in this groups underwent VATS with wedge recession, performed deep breathing and coughing exercises while listening to music for thirty minutes a day with a MP3 player and head phones on postoperative three days.

干预措施: Listening music (Behavioral)

Controlled group

No Intervention

Patients in this groups underwent VATS with wedge recession, performed deep breathing and coughing exercises for postoperative three days without music

结局指标

主要结局

systolic blood pressure

时间窗: through study completion, an average of 6 months

mm Hg (millimeters of mercury)

diastolic blood pressure

时间窗: through study completion, an average of 6 months

mm Hg (millimeters of mercury)

次要结局

  • forced expiratory volume in one second (FEV1)(through study completion, an average of 6 months)
  • forced vital capacity (FVC)(through study completion, an average of 6 months)

研究者

发起方
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ozgu Bakcek

Lecturer, RN, MSc

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

研究点 (1)

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