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临床试验/NCT06889935
NCT06889935已完成不适用

The Effect of Respiratory Exercise Diary Use on Postoperative Pain in Patients Undergoing Cardiovascular Surgery

Marmara University1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2024年7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
74
试验地点
1
主要终点
Visual analogue scale (VAS)

研究概览

简要总结

The study was carried out to evaluate the effect of respiratory exercise diary use on postoperative pain in patients undergoing elective cardiovascular surgery in a training and research hospital in Istanbul.

详细描述

The randomised controlled experimental study was conducted between 11 July 2024 and 11 January 2025 in the cardiovascular surgery inpatient wards of a training and research hospital in Istanbul. The study was conducted with a total of 74 patients, 37 in the control group and 37 in the intervention group. Data were collected by the researcher through face-to-face interviews with the patients. 'Patient Identification Form', "Visual Analogue Scale (VAS)", "Respiratory Exercise Diary" were used.

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
Double (Participant, Outcomes Assessor)

盲法说明

In order to avoid bias in the people included in the study, randomisation was performed. The randomisation table was created by using the address 'https://www.calculatorsoup.com'.

In this study, full (double) blinding was not possible because the researcher was the one who implemented the intervention. However, since the participants did not know which group they were included in, blinding was provided at the level of the participants. Blinding was performed while obtaining 'Informed Voluntary Consent'. In this study, in which single blinding method was used, an external biostatistician was assigned during the statistical analysis process and thus blinding was also performed at the analysis stage.

入排标准

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

入选标准

  • •No barriers to verbal communication (mental, physiological and psychological)
  • •Patients undergoing elective cardiovascular surgery,
  • •Individuals who agreed to participate in the study,
  • •Patients whose haemodynamics are suitable for respiratory exercise

排除标准

  • •Being in the intensive care unit after surgical intervention,
  • •Patients undergoing re-operation after surgical intervention,
  • •Those who do not accept the study or who want to leave during the study.

研究组 & 干预措施

Group using a respiratory exercise diary (intervention group)

Active Comparator

All of the patients included in the group were asked to fill in the 'Patient Identification Form' and pain assessment was performed with 'Visual Analogue Scale (VAS)'. Information was given about respiratory exercises and spirometry, which is routinely used in the postoperative period in patients undergoing cardiovascular surgery in the hospital where the study was conducted. Respiratory Exercise Diary was introduced to this group and its use was demonstrated practically. They were asked to record the exercises performed in this diary. Pain assessment was performed with Visual Analogue Scale for the first 3 days after surgery. On the 1st postoperative day, this group was informed again about respiratory exercises, spirometer and its daily use, and the first exercises and records were made together with the researcher. They were asked to continue the exercises and recordings themselves for the first 3 days.

干预措施: Exercise diary (Other)

Group not using a respiratory exercise diary (control group)

No Intervention

'Patient Identification Form' was filled out for all patients and pain assessment was performed with 'Visual Analogue Scale (VAS)'. Information was given about respiratory exercises and spirometry, which is routinely used in the postoperative period in patients undergoing cardiovascular surgery in the hospital where the study was conducted. This group was asked to note the exercises on a piece of paper. Pain assessment was performed with Visual Analogue Scale in the first 3 days postoperatively. On the 1st postoperative day, the information about breathing exercises and recording procedures was repeated and the practices continued in the routine functioning of the clinic.

结局指标

主要结局

Visual analogue scale (VAS)

时间窗: four days

VAS is a very common scale used for pain assessment in daily practice and in this assessment, pain averages ranging from 0 to 10 are given on a 10 cm straight line in a horizontal or vertical plane. In the scale used to determine the pain intensity of patients, pain is graded between 0 (no pain) and 10 (unbearable pain). Accordingly, while '0' indicates no pain, an average VAS value of less than 3 indicates mild pain, 3-6 indicates mild-moderate pain, and greater than 6 indicates moderate-severe pain. VAS is an accepted scale in the world literature that visually describes pain intensity, provides ease of use and consists of a single question.

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

Melisa Köse

Principal Investigator

Marmara University

研究点 (1)

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