Pain ManagementNCT07370857
The Effect of Music Medicine on Anxiety and Pain Levels in Women Undergoing Embryo Transfer: A Randomized Controlled Trial
A study testing "Patient-Selected Music Medicine in people with Pain Management and Infertility (IVF Patients), run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain Management, Infertility (IVF Patients), Anxiety
- What is being tested?
- "Patient-Selected Music Medicine
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2025to 17 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Pain Management, Infertility (IVF Patients), Anxiety
- Being tested
- "Patient-Selected Music Medicine
- Medical subject headings
- Agnosia, Infertility, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Patient-Selected Music MedicineBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Music Medicine Group | Experimental | Patients in this group receive music medicine intervention in addition to standard care during the embryo transfer process. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at two time points: baseline (pre-test, upon admission to the room) and 15 minutes after the embryo transfer procedure (post-test).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start1 May 2025
- Primary completion1 Oct 2025
- Study completion17 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, helin kalır, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07370857
- Sponsor's protocol ID
- Hasan Kalyoncu
- Status last verified
- May 2025
- First submitted
- 17 Dec 2025
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared to protect participant privacy and because the data are currently being used as part of a doctoral dissertation. Results will be disseminated through publication in peer-reviewed journals.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music Medicine on Anxiety and Pain Levels in Women Undergoing Embryo Transfer: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07370857
- Acronym / sponsor ID
- Hasan Kalyoncu
- Conditions
- Pain Management, Infertility (IVF Patients), Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 17 Dec 2025 (actual)
- First posted
- 27 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Music Medicine Group | Experimental | Behavioral: "Patient-Selected Music MedicinePatients in this group receive music medicine intervention in addition to standard care during the embryo transfer process. |
| Control Group | No intervention | –Participants receive only the standard clinical procedures and routine care for embryo transfer without any music intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "Patient-Selected Music MedicineParticipants 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. | Behavioural | Music Medicine Group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared to protect participant privacy and because the data are currently being used as part of a doctoral dissertation. Results will be disseminated through publication in peer-reviewed journals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Patient-Selected Music Medicine in people with Pain Management and Infertility (IVF Patients), run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.