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The Effect of Music Therapy on Analgesia and Oxidative Stress Parameters

Primary Purpose

Infertility, Anesthesia

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
music therapy
Sponsored by
Kahramanmaras Sutcu Imam University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Infertility focused on measuring music therapy, pain, oxidative stress parameters

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Kahramanmaras Sutcu Imam University Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

Group 1

Music Therapy Group 2

Music Therapy Group 3

Arm Description

Group 1 is control group that does not listen to music

Group 2 is the group listening to preoperative music

Group 3 is the preoperative and peroperative music listening group (continuous)

Outcomes

Primary Outcome Measures

Oxidative stress markers with the music therapy
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 Outcome Measures

Pain Scores
VAS (Visual analog scale) Score. from 1 to 10 , 0: No pain, 10: 10 pain that can not be tolerated
Hemodynamics and oxygen follow-up
Systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate,
Hemodynamics and oxygen follow-up
Systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate,

Full Information

First Posted
November 7, 2017
Last Updated
March 8, 2019
Sponsor
Kahramanmaras Sutcu Imam University
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1. Study Identification

Unique Protocol Identification Number
NCT03346031
Brief Title
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

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
October 15, 2017 (Actual)
Primary Completion Date
April 1, 2018 (Actual)
Study Completion Date
June 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kahramanmaras Sutcu Imam University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Anesthesia
Keywords
music therapy, pain, oxidative stress parameters

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
No Intervention
Arm Description
Group 1 is control group that does not listen to music
Arm Title
Music Therapy Group 2
Arm Type
Active Comparator
Arm Description
Group 2 is the group listening to preoperative music
Arm Title
Music Therapy Group 3
Arm Type
Active Comparator
Arm Description
Group 3 is the preoperative and peroperative music listening group (continuous)
Intervention Type
Procedure
Intervention Name(s)
music therapy
Intervention Description
patients will listen to music with an MP3 headset
Primary Outcome Measure Information:
Title
Oxidative stress markers with the music therapy
Description
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
Time Frame
Change from baseline at 1 hour
Secondary Outcome Measure Information:
Title
Pain Scores
Description
VAS (Visual analog scale) Score. from 1 to 10 , 0: No pain, 10: 10 pain that can not be tolerated
Time Frame
1 minute,5 minute,15 minute,30 minute, 60 minute of pain level after operation
Title
Hemodynamics and oxygen follow-up
Description
Systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate,
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
Title
Hemodynamics and oxygen follow-up
Description
Systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate,
Time Frame
after the operation in 1 minute, 5 minutes, 15 minutes, 30 minutes, 60 minutes.Each unit will be evaluated separately within itself

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
yavuz orak, md
Organizational Affiliation
Kahramanmaraş Sutcu Imam University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kahramanmaras Sutcu Imam University Faculty of Medicine
City
Kahramanmaraş
State/Province
Onikişubat
ZIP/Postal Code
251/A 46040
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Music Therapy on Analgesia and Oxidative Stress Parameters

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