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

Not Applicable

• Conditions: Infertility
• Interventions: Other: music therapy

• Registration Number: NCT06117202
• Lead Sponsor: Uludag University

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.

Study Timeline

• Study Start: 2023-08-17
• Study First Submitted: 2023-10-30
• Study First Submitted QC: 2023-11-02
• Study First Posted: 2023-11-03
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-18
• Last Update Posted: 2023-12-22
• Primary Completion: 2025-03-18
• Study Completion: 2025-05-18

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 240

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
music therapy	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.

Primary Outcome Measures

Name	Time	Method
stress,anxiety levels	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 Outcome Measures

Name	Time	Method
Postoperative pain level	30 minutes	The participants' pain levels will be assessed using the Visual Analog Scale (0-10 point). A score of zero on this scale represents a pain-free condition for the patient, while the highest score reflects the most severe pain they have experienced in their life.

Trial Locations

Locations (1)

Uludag University; 🇹🇷 Bursa, Turkey