NCT03346031

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2017

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

March 11, 2019

Status Verified

July 1, 2018

Enrollment Period

6 months

First QC Date

November 7, 2017

Last Update Submit

March 8, 2019

Conditions

Keywords

music therapy, pain, oxidative stress parameters

Outcome Measures

Primary Outcomes (1)

  • 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

    Change from baseline at 1 hour

Secondary Outcomes (3)

  • Pain Scores

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

  • Hemodynamics and oxygen follow-up

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

  • Hemodynamics and oxygen follow-up

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

Study Arms (3)

Group 1

NO INTERVENTION

Group 1 is control group that does not listen to music

Music Therapy Group 2

ACTIVE COMPARATOR

Group 2 is the group listening to preoperative music

Procedure: music therapy

Music Therapy Group 3

ACTIVE COMPARATOR

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

Procedure: music therapy

Interventions

music therapyPROCEDURE

patients will listen to music with an MP3 headset

Music Therapy Group 2Music Therapy Group 3

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kahramanmaras Sutcu Imam University Faculty of Medicine

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

Location

MeSH Terms

Conditions

InfertilityPain

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • yavuz orak, md

    Kahramanmaras Sutcu Imam University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 7, 2017

First Posted

November 17, 2017

Study Start

October 15, 2017

Primary Completion

April 1, 2018

Study Completion

June 1, 2018

Last Updated

March 11, 2019

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations