Skip to main content
OpenTrials
Completed

NCT Number: NCT04175873

The Effect of Music Therapy on Glutathione Peroxidase, Malondialdehyde and Pain in Oocyt Pick Up Patients.

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kahramanmaras Sutcu Imam Univercity Faculty of edicine, Kahramanmaraş, Onikişubat, Turkey (Türkiye)

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Music

Other

Patients will listen to music with MP3 headphones for 1 hour preoperatively and throughout the operation.

Primary outcomes

  1. Glutathione Peroxidase markers with the music therapy

    Time frame: 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,

  2. Malondialdehyde markers with the music therapy

    Time frame: 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

  3. Pain Score

    Time frame: 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

Secondary outcomes

  1. Hemodynamics

    Time frame: Changing during the operation, 1 minute, 3 minutes, 5 minutes, 7 minutes, 10 minutes, 15 minutes.Each unit will be evaluated separately within itself

    Systolic blood pressure (mmHg), diastolic blood pressure (mm Hg), mean arterial pressure (mmHg),

  2. Hemodynamics

    Time frame: Changing after the operation in 1 minute, 5 minutes, 15 minutes, 30 minutes, 60 minutes.Each unit will be evaluated separately within itself

    Systolic blood pressure (mmHg), diastolic blood pressure (mmHg), mean arterial pressure (mmHg), heart rate,

  3. Heart rate

    Time frame: 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

  4. STAI

    Time frame: Change from baseline in one hour before operation and about 1st hour after operation

    State-Trait Anxiety Inventory Score

Sponsors and collaborators

Lead sponsor

Kahramanmaras Sutcu Imam University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 25, 2019
Registry last updated
May 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.