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临床试验/NCT04175873
NCT04175873已完成不适用

Effects of Music Therapy on Glutathione Peroxidase, Malondialdehyde and Pain in Oocyt Pick Up Patients: A Prospective, Randomized, Controlled Clinical Study)

Kahramanmaras Sutcu Imam University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年11月25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
60
试验地点
2
主要终点
Pain Score

研究概览

简要总结

It is used by music therapists to help the social, physical, emotional, psychological and psychological needs of patients. In a study, music has a positive effect on pain, anxiety, depression, shortness of breath, mood, facial expression and speech . The aim of this study was to investigate analgesia consumption during egg collection and postoperative period of music therapy and to compare and evaluate oxidative stress parameters in blood and follicle fluids.

详细描述

Patients will be divided into 2 groups. Group C (n = 30): Control group. Group M (n = 30): Music group. Preoperative 1 hour and during the operation of Classical Turkish Music (Acemaşiran makam) will listen to the group. After the patient is taken to the resting room, blood will be prepared for the operation (for malondialdehyde and glutathione peroxidase). Then STAI 1-2 anxiety form will be filled in under the supervision of the nurse. In Group M patients, blood will be taken to the patient resting room (for malondialdehyde, glutathione peroxidase). You will then play music with the MP3 headset for 1 hour. Then STAI 1-2 anxiety form will be filled in under the supervision of the nurse.Operation room will be taken. Remifentanil 0.5 mcg / kg and propofol 2 mg / kg will be administered for induction after all patients included in the study (Group C and Group M). Patients will be given BIS. Anesthetize BIS between 40-50. Hemodynamics follow-up (Systolic blood pressure, Diastolic blood pressure, Heart rate, Oxygen saturation) during the operation and the need for additional analgesia and anesthesia during the operation will be recorded. At the end of the operation, blood will be taken to compare the values of Oxidative Stress Parameters in the blood and follicle fluids. In the rest rooms, hemodynamics and pain follow-ups will be recorded at 1,5,15, 30, and 60 minutes. NRS (Numeric Rating Scale) will be used for pain monitoring. Analgesic needs of patients with pain will be met. Non-steroid anti-inflammatory (Naproxen Na) drug will be used for postoperative analgesia. At the end of the study, analgesia / anesthetic consumption, preoperative and postoperative blood oxidative stress parameters Glutathione peroxidase and Malondialdehyde will be compared in patients receiving music therapy and in patients without music therapy (control group). After the blood is drawn to both groups in the postoperative period, the STAI 1-2 questionnaire will be filled in under the supervision of the nurse and preoperative and postoperative comparisons will be made. The results will be correlated with the results.

Bispectral Index (BIS) monitoring is a new advanced electroencephalogram (EEG) based method for monitoring anesthetic depth (4). The monitor uses BIS analysis to obtain an index of anesthesia depth (5). BIS is a dimensionless number scaled from 100 to 0, and decreasing values show more sedation and hypnosis. A BIS value of 100 represents normal cortical electrical activity (an awake EEG), and a value of zero indicates a cortical electrical silence (cortical suppression).

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
Single (Care Provider)

盲法说明

The patients will be listening to music with MP3 headphones for 1 hour preoperatively and throughout the operation.

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Patients with ASA 1
  • •Conscious patients
  • •Voluntary patients
  • •Patients without hearing problems
  • •Patients in the 18-35 age range
  • •Patients without music phobia will be included in the study
  • •Non-metabolic disease
  • •Patients without liver and kidney disease
  • •Patients without bleeding disorders

排除标准

  • •Non-volunteer
  • •Non-18-35 age range
  • •Patients without ASA 1
  • •Liver, Kidney and Metabolic Disease
  • •Unconscious
  • •Patients with hearing problems

研究组 & 干预措施

Group C

No Intervention

Control group.

Group M

Experimental

Music group.Preoperative 1 hour and during the operation of Classical Turkish Music (Acemaşiran makam) listening group

干预措施: music (Other)

结局指标

主要结局

Pain Score

时间窗: after operation changing of pain level at 1 minute,5 minute,15 minute,30 minute, 60 minute

VAS (Visual analog scale) Score. from 1 to 10 , 0: No pain, 10: 10 pain that can not be tolerated

Glutathione Peroxidase markers with the music therapy

时间窗: Change from baseline in one hour before operation and about 1st hour after operation

To evaluate the impact on the circulating levels of Glutathione Peroxidase ü/ml,

Malondialdehyde markers with the music therapy

时间窗: Change from baseline in one hour before operation and about 1st hour after operation

To evaluate the impact on the circulating levels of Malondialdehyde nmol/ ml

次要结局

  • STAI(Change from baseline in one hour before operation and about 1st hour after operation)
  • Hemodynamics(Changing after the operation in 1 minute, 5 minutes, 15 minutes, 30 minutes, 60 minutes.Each unit will be evaluated separately within itself)
  • Heart rate(Changing after the operation in 1 minute, 5 minutes, 15 minutes, 30 minutes, 60 minutes.Each unit will be evaluated separately within itself)
  • Hemodynamics(Changing 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 (2)

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