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

Infertility Clinical Trial

— IVF  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06117202
• Other study ID #: Uludag University1
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 17, 2023
• Est. completion date: May 18, 2025

Study information

• Verified date: December 2023
• Source: Uludag University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 240
• Est. completion date: May 18, 2025
• Est. primary completion date: March 18, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Infertility

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Turkey	Uludag University	Bursa

Sponsors (1)

Lead Sponsor	Collaborator
Uludag University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	stress,anxiety levels	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.	30 minutes
Secondary	Postoperative pain level	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.	30 minutes