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临床试验/NCT03346031
NCT03346031已完成不适用

Assessment of the Effect of Music Therapy on Analgesia and Oxidative Stress Parameters in Anesthetized Oocyt Pickup Patients

Kahramanmaras Sutcu Imam University1 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2017年10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
93
试验地点
1
主要终点
Oxidative stress markers with the music therapy

研究概览

简要总结

Music has been used in the treatment of patient since the time Plato, Hippocrates and Alpharabius were alive. It is used by music therapists to help patients' social, physical, emotional, psychological and spiritual needs. In a study conducted, it was seen that music has a positive effect on pain, anxiety, depression, shortness of breath, mood, face expression and speech. Our aim is to evaluate the analgesic consumption of music therapy during egg collection applications and to compare the parameters of oxidative stress in blood and follicular fluid.

详细描述

Patients were randomly allocated into 3 groups. Group 1 is control group. Group 2 is Classical Turkish Music group. Group 3 will be organized as a group listening continuously (Preoperative and peroperative) Classical Turkish Music (Acemaşiran Makam). Voluntary patients, patients without hearing problems, patients between the ages of 18 and 40, and patients without music phobia will be included in the study. Patients who do not want to participate in the study, patients with hearing problems, and patients outside the 18-40 age range will not be included in the study. Once the Control group has been taken to the patient's room, the vessel way will be prepared for operation and will be kept waiting for one hour. Then blood will be taken to evaluate the oxidative stress parameters (Superoxide Dysmotase, Catalase, Glutathione Peroxidase, Myeloperoxidase, Malondialdehyde, Nitric Oxide, Thiol Disulfide levels) and taken to the operation room. Group 2 patients will be taken to the patient's rest room and will listen to music with an MP3 headset for 1 hour. Patient's blood will be taken to assess the oxidative stress parameters and taken to the operation room. Group 3 will listen Turkish Classical Music for 1 hour in patient room, vein path will be opened, Patient's blood will be taken with the aim of evaluating oxidative stress parameters and taken to the operation room. The patients will listen to music throughout the operation. All patients included in the study (Gr.1, Gr.2, Gr.3 patients) will use remifentanil 0.5 mcg / kg, propofol 1 mg / kg on induction after taken to the operating table. Hemodynamics (Systolic Blood Pressure, Diastolic Blood Pressure, Heart Rate, Oxygen Saturation, Mean arterial pressure) and body movements of all patients included in the study will be recorded. Additional anesthesia and analgesia needs will be recorded during the operation at 1,3,5,7,10,15 minutes. Blood and follicle fluid will be taken with the aim of comparing the values of Oxidative Stress Parameters in blood and follicular fluid at the end of the operation of all the patients in the three groups included in the study. Hemodynamics follow-up and pain follow-ups will be recorded at 1,5,15,30, and 60 minutes in the postoperative resting rooms of the patients after the operation. VAS will be used for pain recording. The analgesic needs of the patients will be met. Non-steroidal anti-inflammatory drugs will be administered to patients for postoperative analgesia. The pre-and post-operative oxidative stress parameters in patients blood will be compared and the oxidative stress parameter values of the follicular fluid of the patients after the operation will be compared in the three groups.

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)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •1.Voluntary patients
  • •patients without hearing problems
  • •patients between the ages of 18 and 40
  • •patients without music phobia

排除标准

  • •Patients with hearing problems.
  • •Patients older than 18 years and older than 40 years
  • •Patients who do not want to participate in the trial
  • •Patients with music phobia

研究组 & 干预措施

Group 1

No Intervention

Group 1 is control group that does not listen to music

Music Therapy Group 2

Active Comparator

Group 2 is the group listening to preoperative music

干预措施: music therapy (Procedure)

Music Therapy Group 3

Active Comparator

Group 3 is the preoperative and peroperative music listening group (continuous)

干预措施: music therapy (Procedure)

结局指标

主要结局

Oxidative stress markers with the music therapy

时间窗: Change from baseline at 1 hour

To evaluate the impact on the circulating levels of Catalase ü/ml,Glutathione Peroxidase ü/ml, Myeloperoxidase ü/ml, Malondialdehyde nmol/ ml, Nitric Oxide umol/ L, Thiol Disulfide

次要结局

  • Hemodynamics and oxygen follow-up(after the operation in 1 minute, 5 minutes, 15 minutes, 30 minutes, 60 minutes.Each unit will be evaluated separately within itself)
  • Pain Scores(1 minute,5 minute,15 minute,30 minute, 60 minute of pain level after operation)
  • Hemodynamics and oxygen follow-up(During the operation, 1 minute, 3 minutes, 5 minutes, 7 minutes, 10 minutes, 15 minutes.Each unit will be evaluated separately within itself)

研究者

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

Yavuz Orak

Assistant Professor

Kahramanmaras Sutcu Imam University

研究点 (1)

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