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Clinical Trials/NCT06117202
NCT06117202
Enrolling By Invitation
Not Applicable

The Effect of Interactive Music Therapy Applied for Women During the Perioperative Period for In Vitro Fertilization(IVF) on Their Stress Levels

Uludag University1 site in 1 country240 target enrollmentAugust 17, 2023
ConditionsInfertility

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Infertility
Sponsor
Uludag University
Enrollment
240
Locations
1
Primary Endpoint
stress,anxiety levels
Status
Enrolling By Invitation
Last Updated
2 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
August 17, 2023
End Date
May 18, 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Crossover
Sex
Female

Investigators

Sponsor
Uludag University
Responsible Party
Principal Investigator
Principal Investigator

Gizem Nur BAYRAM

research assistant doctor

Uludag University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

stress,anxiety levels

Time Frame: 30 minutes

The stress levels of the participants will be assessed using the State-Trait Anxiety Inventory scale. The obtained scores theoretically range between 20 and 80. A high score represents a high level of anxiety, while a low score indicates a low level of anxiety.

Secondary Outcomes

  • Postoperative pain level(30 minutes)

Study Sites (1)

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