跳至主要内容
临床试验/NCT04755114
NCT04755114已完成不适用

İnönü University Faculty of Nursing Lecturer

Inonu University2 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2021年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
138
试验地点
2
主要终点
Numerical Pain Rating Scale (NPRS)

研究概览

简要总结

The aim of this thesis is; It was planned to determine the effect of Turkish music and comedy films on pain, vital signs and cortisol levels of patients who had orthopedic surgery.

The research is a randomized controlled study. 132 patients who meet the research conditions will be included in the study. Patient Information Form, Numerical Pain Rating Scale, Physiological Parameter Form developed by the researcher will be used for data collection.

详细描述

Turkish Music and Comedy Film Group Data Collection After the patient introduction form is filled, pain level, blood pressure, pulse and respiratory rate will be evaluated, saliva sample will be taken to determine the cortisol level and pre-test data will be collected (0 min). Immediately after the pre-test evaluations, the music group will be played to the music desired by the patient for 30 minutes, and the comedy film group will be shown a comedy movie video. Immediately after the interventions, pain level, vital signs will be evaluated and saliva sample will be taken as a final test (30 minutes). The same procedures will be repeated in the 60th minute after the intervention to determine the duration of the interventions applied.

Control group Data Collection After the patient introduction form is filled, pain level, blood pressure, pulse and respiratory rate will be evaluated, saliva sample will be taken to determine the cortisol level and pre-test data will be collected (0 min).

Pain level and vital signs will be evaluated and saliva sample will be taken for the final test (30th minute) and follow-up (60th minute) simultaneously with the administration group without any intervention.

Collection of Saliva Samples Salivary cortisol is free cortisol not bound to plasma proteins. Considering that the active cortisol is free cortisol, many studies have used the measurement of cortisol in saliva. In addition, salivary cortisol measurement is considered to be a reliable method for measuring stress, since it can be easily obtained, it does not cause stress because it is not invasive, and it shows strong correlation between plasma cortisol levels.

The concentration of cortisol is at its maximum shortly after waking up in the morning, depending on the circadian rhythm. It then declines gradually throughout the day and reaches its lowest level at night. Salivary cortisol also matches the 24-hour rhythm of plasma cortisol.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Supportive Care
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

入选标准

  • Does not have any communication problem that will prevent him from understanding the information given, listening to music, watching movies and expressing the pain level correctly,
  • Expressing that he experienced "moderate" or "severe" (4 and above according to the Numerical Rating Scale-SDS) pain after the operation,
  • Having been operated under general anesthesia and 24 hours after surgery,
  • No complications (severe bleeding, nausea, vomiting, etc.) developed in the early postoperative period,
  • Without a chronic cardiovascular and respiratory system disease and hormonal problems
  • Patients not receiving steroid therapy will be included in the study.

排除标准

  • Those with pain score below 4
  • Those who have recently used analgesic medication
  • Those who have recently consumed any food or drink

结局指标

主要结局

Numerical Pain Rating Scale (NPRS)

时间窗: 5 months

Each participant has 60 minutes between pretest and posttest. The first follow-up will be done at the first meeting, the second follow-up in the 30th minute, and the last follow-up at the 60th minute. There are 11 points on this scale with numbers between 0-10. The "0" point on the left indicates "no pain", "the point" 10 "on the right indicates" the worst pain imaginable ".

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

Hatice OLTULUOĞLU

Director

Inonu University

研究点 (2)

Loading locations...

相似试验