Clinical trial NCT04175873: The Effect of Music Therapy on Glutathione Peroxidase, Malondialdehyde and Pain in Oocyt Pick Up Patients.
Official title: Effects of Music Therapy on Glutathione Peroxidase, Malondialdehyde and Pain in Oocyt Pick Up Patients: A Prospective, Randomized, Controlled Clinical Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Anesthesia
Oxidative Stress
Pain, Postoperative
Keywords: music therapy
pain
oxidative stress
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
First posted: 2019-11-25
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients will be listening to music with MP3 headphones for 1 hour preoperatively and throughout the operation.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Glutathione Peroxidase markers with the music therapy
timeFrame: Change from baseline in one hour before operation and about 1st hour after operation
measure: Malondialdehyde markers with the music therapy
timeFrame: Change from baseline in one hour before operation and about 1st hour after operation
measure: Pain Score
timeFrame: after operation changing of pain level at 1 minute,5 minute,15 minute,30 minute, 60 minute
Secondary outcomes:
measure: Hemodynamics
timeFrame: Changing during the operation, 1 minute, 3 minutes, 5 minutes, 7 minutes, 10 minutes, 15 minutes.Each unit will be evaluated separately within itself
measure: Hemodynamics
timeFrame: Changing after the operation in 1 minute, 5 minutes, 15 minutes, 30 minutes, 60 minutes.Each unit will be evaluated separately within itself
measure: Heart rate
timeFrame: Changing after the operation in 1 minute, 5 minutes, 15 minutes, 30 minutes, 60 minutes.Each unit will be evaluated separately within itself
measure: STAI
timeFrame: Change from baseline in one hour before operation and about 1st hour after operation
Other outcomes:
Locations:
city: Kahramanmaraş
country: Turkey
facility: Kahramanmaras Sutcu Imam Univercity Faculty of edicine
state: Onikişubat
city: Kahramanmaraş
country: Turkey
facility: Kahramanmaras Sutcu Imam University Faculty of Medicine
state: Onikişubat
Study officials:
affiliation: Kahramanmaraş Sutcu Imam University Faculty of Medicine
name: yavuz orak
role: PRINCIPAL_INVESTIGATOR
References: