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临床试验/NCT06820788
NCT06820788已完成不适用

Principal Investigator, Assistant Professor Şerafettin OKUTAN, Surgical Nursing, Faculty of Health Sciences, Bitlis Eren University

Bitlis Eren University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年3月1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
120
试验地点
1
主要终点
pain level

研究概览

简要总结

It is planned to examine the effects of local music on pain and comfort levels in patients undergoing laparoscopic abdominal surgery and to make a comparison between Turkey and Iran with the results obtained.

The hypotheses of the study are as follows:

H1-0: Music has no effect on reducing pain in patients undergoing laparoscopic abdominal surgery.

H1-1: Music has an effect on reducing pain in patients undergoing laparoscopic abdominal surgery.

H2-0: Music has no effect on increasing comfort in patients undergoing laparoscopic abdominal surgery.

H2-1: Music has an effect on increasing comfort in patients undergoing laparoscopic abdominal surgery.

详细描述

As part of the pre-test, the patient introduction form, comfort and pain scales will be applied to the experimental group patients. Music will be played in the patient room 2 hours after the patients are transferred from the post-operative care unit to the clinic, which is the most appropriate time after surgery, when vital signs are stable and clinical compliance is achieved. Music will be played for 20 minutes. As part of the post-test, the comfort and pain scales will be applied to the experimental group patients again.

As part of the pre-test, the patient introduction form, comfort and pain scales will be applied to the control group patients. No intervention will be applied to the control group patients and the clinic's routine practices will continue. As part of the post-test, the comfort and pain scales will be applied to the control group patients again.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

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

  • •Must be over 18 years old
  • •Must not have communication problems

排除标准

  • •Having any hearing or mental problems
  • •Laparoscopic surgery converted to open surgery

研究组 & 干预措施

Intervention Group

Experimental

As part of the pre-test, the patient introduction form, comfort and pain scales will be applied to the experimental group patients. Music will be played in the patient room 2 hours after the patients are transferred from the post-operative care unit to the clinic, which is the most appropriate time after surgery, when vital signs are stable and clinical compliance is achieved. Music will be played for 20 minutes. As part of the post-test, the comfort and pain scales will be applied to the experimental group patients again.

干预措施: music therapy (Other)

Control Group

No Intervention

As part of the pre-test, the patient introduction form, comfort and pain scales will be applied to the control group patients. No intervention will be applied to the control group patients and the clinic's routine practices will continue. As part of the post-test, the comfort and pain scales will be applied to the control group patients again.

结局指标

主要结局

pain level

时间窗: The patients will be given the scale in the patient room 2 hours after the surgery. The scale will be given again as a final test immediately after the music listening is over.

Numerical Rating Scale: This scale, which is intended to determine the severity of pain, aims to have the patient describe their pain with numbers. In the form, 0 points are evaluated as "no pain", 1-3 points as "mild pain", 4-6 points as "moderate pain", and 7 and above points as "severe pain"

comfort level

时间窗: The patients will be given the scale in the patient room 2 hours after the surgery. The scale will be given again as a final test immediately after the music listening is over.

General Comfort Scale Short Form: General Comfort Scale Short Form is the Turkish adaptation of the General Comfort Scale developed by Kolcaba to measure the individual's comfort level in a more understandable way and in a shorter time. The scale consists of 28 items and the items of the scale are scored between 28-168. High scores indicate a high level of comfort.

次要结局

未报告次要终点

研究者

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

Serafettin Okutan

Principal Investigator, Assistant Professor Şerafettin OKUTAN, Surgical Nursing, Faculty of Health Sciences, Bitlis Eren University

Bitlis Eren University

研究点 (1)

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