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临床试验/NCT06117202
NCT06117202Enrolling By Invitation不适用

The Effect of Interactive Music Therapy Applied for Women During the Perioperative Period for In Vitro Fertilization(IVF) on Their Stress Levels

Uludag University2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2023年8月17日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
240
试验地点
2
主要终点
stress,anxiety levels

研究概览

简要总结

The purpose of this study is to investigate the effect of music therapy on stress levels in female patients applying for in vitro fertilization.

详细描述

If the patients participate in the study, when they apply to the in vitro fertilization center, they will meet with their anesthesiologist, anesthesia assessment will be done face to face and asked some questions about the diseases that may affect the procedure. . If patients are included in the study, their blood pressure, blood oxygen value and heart rate will be measured and recorded, as in every patient. Subsequently, a test will be administered to assess stress and anxiety levels of the patients. The patients involved in the study will be randomly divided into two groups. One group will be provided with a set of headphones that completely cover the ears and will be played their selected music from a predetermined album for 20 minutes before the procedure. The music will continue to be played through the headphones during the procedure. The other group will be taken to the operating room without any procedure, and this process will be applied to both groups. When patients are brought to the operating room, blood pressure, blood oxygen levels, and heart rate will be measured and recorded once again. Routine anesthesia procedures, applicable to all, will be carried out. After patients are fully awake, their pain condition will be assessed using a visual test.

研究设计

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

入排标准

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

入选标准

  • 18 years and older,
  • American Society of Anesthesiologists (ASA) scores I-III.

排除标准

  • Patients who did not provide informed consent,
  • Used anxiolytics, alcohol, or drugs before the procedure,
  • Refused to participate in the study,
  • Lost their hearing ability for any reason.

结局指标

主要结局

stress,anxiety levels

时间窗: 30 minutes

The stress levels of the participants will be assessed using the State-Trait Anxiety Inventory scale. The obtained scores theoretically range between 20 and 80. A high score represents a high level of anxiety, while a low score indicates a low level of anxiety.

次要结局

  • Postoperative pain level(30 minutes)

研究者

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

Gizem Nur BAYRAM

research assistant doctor

Uludag University

研究点 (2)

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