Clinical trial NCT03346031: The Effect of Music Therapy on Analgesia and Oxidative Stress Parameters
Official title: Assessment of the Effect of Music Therapy on Analgesia and Oxidative Stress Parameters in Anesthetized Oocyt Pickup Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Anesthesia
Keywords: music therapy, pain, oxidative stress parameters
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 93
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1.Voluntary patients

1. patients without hearing problems
2. patients between the ages of 18 and 40
3. patients without music phobia

Exclusion Criteria:

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

Primary outcomes:
measure: Oxidative stress markers with the music therapy
timeFrame: Change from baseline at 1 hour
Secondary outcomes:
measure: Pain Scores
timeFrame: 1 minute,5 minute,15 minute,30 minute, 60 minute of pain level after operation
measure: Hemodynamics and oxygen follow-up
timeFrame: 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 and oxygen follow-up
timeFrame: after the operation in 1 minute, 5 minutes, 15 minutes, 30 minutes, 60 minutes.Each unit will be evaluated separately within itself
Other outcomes:
Locations:
city: Kahramanmaraş
country: Turkey
facility: Kahramanmaras Sutcu Imam University Faculty of Medicine
state: Onikişubat
Study officials:
affiliation: Kahramanmaras Sutcu Imam University
name: yavuz orak, md
role: PRINCIPAL_INVESTIGATOR
References: