The Effect of Interactive Music Therapy Applied for Women During the Perioperative Period for IVF on Their Stress Levels
IVF
1 other identifier
interventional
240
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 17, 2023
CompletedFirst Submitted
Initial submission to the registry
October 30, 2023
CompletedFirst Posted
Study publicly available on registry
November 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 18, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 18, 2025
CompletedDecember 22, 2023
December 1, 2023
1.6 years
October 30, 2023
December 18, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Postoperative pain level
30 minutes
Study Arms (2)
music therapy
EXPERIMENTALThe 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.
control group
NO INTERVENTIONThe control group will be taken to the operating room with standard anesthesia care protocol.
Interventions
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.
Eligibility Criteria
You may qualify if:
- years and older,
- American Society of Anesthesiologists (ASA) scores I-III.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Uludag University
Bursa, 16059, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Selcan AKESEN
Uludag University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- research assistant doctor
Study Record Dates
First Submitted
October 30, 2023
First Posted
November 3, 2023
Study Start
August 17, 2023
Primary Completion
March 18, 2025
Study Completion
May 18, 2025
Last Updated
December 22, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share