Anxiety, Infertility (IVF Patients), Pain Management
Conditions
Brief summary
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.
Detailed description
The study evaluates the effect of music medicine on anxiety and pain levels during embryo transfer. Participants in the intervention group listen to patient-selected music via noise-canceling headphones. The process includes baseline assessments of vital signs and anxiety, followed by post-intervention measurements 15 minutes after the procedure.
Interventions
BEHAVIORAL"Patient-Selected Music Medicine
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.
Sponsors
Hasan Kalyoncu University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
Randomization was performed using the sealed envelope method to ensure allocation concealment; therefore, the investigator did not know the group assignments until the point of intervention. Due to the nature of the music medicine intervention, the participants and the investigator collecting the data could not be masked during the procedure. However, to minimize bias, the statistical analysis will be conducted by a researcher blinded to the group allocations.
Intervention model description
1. Music Medicine Group (Arm 1) Label: Music Medicine Group Arm Type: Experimental Description: Participants listen to patient-selected music via noise-canceling headphones throughout the embryo transfer procedure and for 15 minutes post-procedure, in addition to standard care. 2. Control Group (Arm 2) Label: Control Group Arm Type: No Intervention Description: Participants receive standard clinical care for the embryo transfer procedure without any music medicine intervention.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| State Anxiety Score | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed