- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07370857
The Effect of Music Medicine on Anxiety and Pain Levels in Women Undergoing Embryo Transfer: A Randomized Controlled Trial
This study was designed to investigate the effects of music medicine on anxiety, pain, and vital signs in women undergoing embryo transfer. The study followed a randomized controlled design and was conducted at the IVF unit of a university hospital. The sample consisted of women who met the specified inclusion criteria, and participants were assigned to the intervention and control groups using randomization.
Data collection tools included a socio-demographic characteristics form, a vital signs recording form (blood pressure, pulse, respiratory rate, and oxygen saturation), the State-Trait Anxiety Inventory (STAI-I and II), and the Visual Analogue Scale (VAS). The intervention group listened to patient-selected music during the embryo transfer process, while the control group received standard care. Measurements were taken before, during, and after the embryo transfer.
The obtained data were analyzed using appropriate statistical methods to evaluate the effects of music on anxiety, pain levels, and vital signs. This study aims to improve women's embryo transfer experiences by contributing to nursing care and reproductive health practices.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Şanlıurfa
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Sanliurfa, Şanlıurfa, Turkey (Türkiye), 63000
- Harran University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Women undergoing embryo transfer.
Ages 18 to 45 years (or your specific age range).
Literacy in Turkish to complete the inventories.
Voluntarily agreeing to participate in the study.
Exclusion Criteria:
Patients with hearing impairment.
Patients with cognitive or psychiatric disorders that prevent completion of the inventory.
Patients who have taken analgesic or anxiolytic medication within the last 24 hours.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Music Medicine Group
Patients in this group receive music medicine intervention in addition to standard care during the embryo transfer process.
|
Participants in the intervention group listen to their pre-selected music through high-quality, over-ear active noise-canceling headphones to ensure acoustic isolation.
The music intervention begins immediately before the embryo transfer, continues throughout the procedure, and extends for 15 minutes in the recovery room.
The volume is adjusted by the patient to a comfortable level, and disposable covers are used on the headphones for hygiene.
|
|
No Intervention: Control Group
Participants receive only the standard clinical procedures and routine care for embryo transfer without any music intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
State Anxiety Score
Time Frame: Measured at two time points: baseline (pre-test, upon admission to the room) and 15 minutes after the embryo transfer procedure (post-test).
|
Measured using the Spielberger State-Trait Anxiety Inventory (STAI).
Only the "State" subscale is used to assess the current level of anxiety related to the embryo transfer procedure.
The score ranges from 20 to 80, where higher scores indicate higher levels of anxiety.
|
Measured at two time points: baseline (pre-test, upon admission to the room) and 15 minutes after the embryo transfer procedure (post-test).
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Hasan Kalyoncu
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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