ANXIETYNCT07898358
Music Therapy and Sedation for Pain and Anxiety During Oocyte Retrieval
An observational study of ANXIETY, run by Samsun University at 1 site in Turkey (Türkiye).
Trial summary
This study is a prospective observational investigation aimed at examining the effect of music intervention on anxiety and pain levels in patients undergoing the ovum pick-up (OPU) procedure under sedation at an IVF center. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- ANXIETY
- How many people
- 146 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Female patients undergoing the IVF procedure
Who may be able to join
- Female patients aged 18-45,
- Scheduled for an OPU procedure,
- Candidates for sedation (ASA I-II).
Who cannot join
- Individuals with hearing impairment,
- Individuals with psychiatric disorders or chronic analgesic use,
- Individuals with contraindications to the sedation protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Samsun Universitesi
Samsun
GOKCE ULTAN OZGEN, SPECIALIST, +90506 7750245, gokceozgen55@gmail.com
About this study
Official title: THE EFFECT OF MUSIC THERAPY COMBINED WITH SEDATION ON ANXIETY AND PAIN DURING THE OOCYTE PİCK-UP (OPU) PROCEDURE IN IVF TREATMENT: A PROSPECTIVE OBSERVATIONAL STUDY
This study is a prospective observational investigation aimed at examining the effect of music intervention on anxiety and pain levels in patients undergoing the ovum pick-up (OPU) procedure under sedation at an IVF center.
The ovum pick-up procedure is a process that is both psychologically stressful and performed under sedation. High levels of anxiety and pain experienced before and during the procedure can reduce patient comfort and increase the need for sedative or analgesic medications. The aim of this study is to evaluate whether listening to music during sedation reduces patients' anxiety levels and to assess its impact on pain perception.
Read more
The results obtained may demonstrate the potential of music, as a non-pharmacological method, to enhance patient comfort during procedures performed under sedation.
The study includes female patients scheduled for the OPU procedure under sedation at an IVF center. Participants will listen to music via headphones during the procedure without undergoing any additional pharmacological or interventional measures. Participation will be voluntary, and written informed consent will be obtained.
- Conditions
- ANXIETY
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MUSIC | Patients whose anxiety levels were measured while listening to music | |
| CONTROL | Patients whose anxiety was measured without exposure to music |
What is being measured
The primary outcome is the main question the study is designed to answer.
ANXIETY
Anxiety levels in these patients will be assessed using the State-Trait Anxiety Inventory (STAI). This widely established 40-item psychological instrument measures anxiety across two distinct dimensions. Total scores range between 20 and 80, where higher scores reflect greater anxiety severity.
Measured: 1 YEAR
Measuring Anxiety Through Music Listening
Anxiety levels in these patients will be assessed using the State-Trait Anxiety Inventory (STAI). This widely established 40-item psychological instrument measures anxiety across two distinct dimensions. Total scores range between 20 and 80, where higher scores reflect greater anxiety severity.
Measured: 1 YEAR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ANXIETYStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hatice Bahadır Altun, SPECIALIST, Principal investigator, SAMSUN UNIVERSITESI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07898358
- Sponsor's protocol ID
- GOKAEK 2025/22/12
- Status last verified
- Sep 2026
- First submitted
- 28 Sep 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: WILL NOT BE SHARED IN ORDER TO PROTECT PATIENTS' PERSONAL DATA
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF MUSIC THERAPY COMBINED WITH SEDATION ON ANXIETY AND PAIN DURING THE OOCYTE PİCK-UP (OPU) PROCEDURE IN IVF TREATMENT: A PROSPECTIVE OBSERVATIONAL STUDY
- ClinicalTrials.gov ID
- NCT07898358
- Acronym / sponsor ID
- GOKAEK 2025/22/12
- Conditions
- ANXIETY
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Oct 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 is a prospective observational investigation aimed at examining the effect of music intervention on anxiety and pain levels in patients undergoing the ovum pick-up (OPU) procedure under sedation at an IVF center.
The ovum pick-up procedure is a process that is both psychologically stressful and performed under sedation. High levels of anxiety and pain experienced before and during the procedure can reduce patient comfort and increase the need for sedative or analgesic medications. The aim of this study is to evaluate whether listening to music during sedation reduces patients' anxiety levels and to assess its impact on pain perception.
The results obtained may demonstrate the potential of music, as a non-pharmacological method, to enhance patient comfort during procedures performed under sedation.
The study includes female patients scheduled for the OPU procedure under sedation at an IVF center. Participants will listen to music via headphones during the procedure without undergoing any additional pharmacological or interventional measures. Participation will be voluntary, and written informed consent will be obtained.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MUSIC | – | –Patients whose anxiety levels were measured while listening to music |
| CONTROL | – | –Patients whose anxiety was measured without exposure to music |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Female patients undergoing the IVF procedure
Key inclusion criteria (3 listed)
- Female patients aged 18-45,
- Scheduled for an OPU procedure,
- Candidates for sedation (ASA I-II).
Key exclusion criteria (3 listed)
- Individuals with hearing impairment,
- Individuals with psychiatric disorders or chronic analgesic use,
- Individuals with contraindications to the sedation protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ANXIETY
Time frame: 1 YEAR
Anxiety levels in these patients will be assessed using the State-Trait Anxiety Inventory (STAI). This widely established 40-item psychological instrument measures anxiety across two distinct dimensions. Total scores range between 20 and 80, where higher scores reflect greater anxiety severity.
Measuring Anxiety Through Music Listening
Time frame: 1 YEAR
Anxiety levels in these patients will be assessed using the State-Trait Anxiety Inventory (STAI). This widely established 40-item psychological instrument measures anxiety across two distinct dimensions. Total scores range between 20 and 80, where higher scores reflect greater anxiety severity.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No. WILL NOT BE SHARED IN ORDER TO PROTECT PATIENTS' PERSONAL DATA
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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.
Hatice Bahadır Altun, SPECIALIST principal investigator
SAMSUN UNIVERSITESI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ANXIETY, run by Samsun 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 3 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: opening soon, as of the sponsor's last update on 27 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hatice Bahadır Altun, SPECIALIST (+905075775727, haticebahadirmd@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ANXIETY (time frame: 1 YEAR). The study lists 2 primary outcomes in all. 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 Oct 2026.