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The Effect of Interactive Music Therapy Applied for Women During the Perioperative Period for IVF on Their Stress Levels

NCT ID: NCT06117202

Last Updated: 2023-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-17

Study Completion Date

2025-05-18

Brief Summary

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The purpose of this study is to investigate the effect of music therapy on stress levels in female patients applying for in vitro fertilization.

Detailed Description

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If the patients participate in the study, when they apply to the in vitro fertilization center, they will meet with their anesthesiologist, anesthesia assessment will be done face to face and asked some questions about the diseases that may affect the procedure. . If patients are included in the study, their blood pressure, blood oxygen value and heart rate will be measured and recorded, as in every patient. Subsequently, a test will be administered to assess stress and anxiety levels of the patients. The patients involved in the study will be randomly divided into two groups. One group will be provided with a set of headphones that completely cover the ears and will be played their selected music from a predetermined album for 20 minutes before the procedure. The music will continue to be played through the headphones during the procedure. The other group will be taken to the operating room without any procedure, and this process will be applied to both groups. When patients are brought to the operating room, blood pressure, blood oxygen levels, and heart rate will be measured and recorded once again. Routine anesthesia procedures, applicable to all, will be carried out. After patients are fully awake, their pain condition will be assessed using a visual test.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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music therapy

The patients involved in the study will be randomly divided into two groups. One group will be provided with a set of headphones that completely cover the ears and will be played their selected music from a predetermined album for 20 minutes before the procedure. The music will continue to be played through the headphones during the procedure.

Group Type EXPERIMENTAL

music therapy

Intervention Type OTHER

The research is a thesis study aimed at determining the stress and anxiety levels of patients seeking in vitro fertilization, investigating influencing factors, and revealing the impact of pre-procedural music listening on these stress and anxiety levels.

control group

The control group will be taken to the operating room with standard anesthesia care protocol.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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music therapy

The research is a thesis study aimed at determining the stress and anxiety levels of patients seeking in vitro fertilization, investigating influencing factors, and revealing the impact of pre-procedural music listening on these stress and anxiety levels.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 18 years and older,
* American Society of Anesthesiologists (ASA) scores I-III.

Exclusion Criteria

* Patients who did not provide informed consent,
* Used anxiolytics, alcohol, or drugs before the procedure,
* Refused to participate in the study,
* Lost their hearing ability for any reason.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Uludag University

OTHER

Sponsor Role lead

Responsible Party

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Gizem Nur BAYRAM

research assistant doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Selcan AKESEN

Role: STUDY_DIRECTOR

Uludag University

Locations

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Uludag University

Bursa, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Uludag University1

Identifier Type: -

Identifier Source: org_study_id