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NCT Number: NCT03346031

The Effect of Music Therapy on Analgesia and Oxidative Stress Parameters

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kahramanmaras Sutcu Imam University Faculty of Medicine

Kahramanmaraş, Onikişubat, 251/A 46040, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

1.Voluntary patients

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

Exclusion criteria

  • 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

Treatment and study plan

Music Therapy

Procedure

patients will listen to music with an MP3 headset

Primary outcomes

  1. Oxidative stress markers with the music therapy

    Time frame: 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

Secondary outcomes

  1. Pain Scores

    Time frame: 1 minute,5 minute,15 minute,30 minute, 60 minute of pain level after operation

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

  2. Hemodynamics and oxygen follow-up

    Time frame: 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, diastolic blood pressure, mean arterial pressure, heart rate,

  3. Hemodynamics and oxygen follow-up

    Time frame: 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, diastolic blood pressure, mean arterial pressure, heart rate,

Sponsors and collaborators

Lead sponsor

Kahramanmaras Sutcu Imam University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 17, 2017
Registry last updated
Mar 11, 2019

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.

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