NCT04175873

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2019

Completed
26 days until next milestone

First Posted

Study publicly available on registry

November 25, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

November 25, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2020

Completed
Last Updated

May 24, 2022

Status Verified

May 1, 2022

Enrollment Period

4 months

First QC Date

October 30, 2019

Last Update Submit

May 17, 2022

Conditions

Keywords

music therapypainoxidative stress

Outcome Measures

Primary Outcomes (3)

  • Glutathione Peroxidase markers with the music therapy

    To evaluate the impact on the circulating levels of Glutathione Peroxidase ü/ml,

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

  • Malondialdehyde markers with the music therapy

    To evaluate the impact on the circulating levels of Malondialdehyde nmol/ ml

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

  • Pain Score

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

    after operation changing of pain level at 1 minute,5 minute,15 minute,30 minute, 60 minute

Secondary Outcomes (4)

  • Hemodynamics

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

  • Hemodynamics

    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

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

  • STAI

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

Study Arms (2)

Group C

NO INTERVENTION

Control group.

Group M

EXPERIMENTAL

Music group.Preoperative 1 hour and during the operation of Classical Turkish Music (Acemaşiran makam) listening group

Other: music

Interventions

musicOTHER

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

Group M

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kahramanmaras Sutcu Imam Univercity Faculty of edicine

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

Location

Kahramanmaras Sutcu Imam University Faculty of Medicine

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

Location

MeSH Terms

Conditions

InfertilityPain, PostoperativePain

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • yavuz orak

    Kahramanmaraş Sutcu Imam University Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
The patients will be listening to music with MP3 headphones for 1 hour preoperatively and throughout the operation.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The patients will be listening to music with MP3 headphones for 1 hour preoperatively and throughout the operation.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 30, 2019

First Posted

November 25, 2019

Study Start

November 25, 2019

Primary Completion

April 1, 2020

Study Completion

May 15, 2020

Last Updated

May 24, 2022

Record last verified: 2022-05

Locations