The Effect of Music Medicine on Anxiety and Pain Levels in Women Undergoing Embryo Transfer: A Randomized Controlled Trial

NCT07370857 | Completed DMC

• 1 other identifier: Hasan Kalyoncu
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Management; Infertility (IVF Patients); Anxiety

Outcome Measures

Primary Outcomes (1)

• State Anxiety Score

  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).

Study Arms (2)

Music Medicine Group

EXPERIMENTAL

Patients in this group receive music medicine intervention in addition to standard care during the embryo transfer process.

Behavioral: "Patient-Selected Music Medicine

Control Group

NO INTERVENTION

Participants receive only the standard clinical procedures and routine care for embryo transfer without any music intervention.

Interventions

"Patient-Selected Music Medicine BEHAVIORAL

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.

Music Medicine Group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hasan Kalyoncu University: lead

Study Sites (1)

Harran University

Sanliurfa, Şanlıurfa, 63000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia; Infertility; Anxiety Disorders

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Diseases; Urogenital Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Model Details: 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.

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: January 27, 2026
• Study Start: May 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: December 17, 2025
• Last Updated: January 27, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)