Intrauterine InseminationNCT05492331
A Study of Music Therapy to Support Intrauterine Insemination
A study testing Music Therapy in people with Intrauterine Insemination, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research is to learn if playing music in the room during an intrauterine insemination procedure decreases anxiety and pain for patients at the time of the procedure. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intrauterine Insemination
- What is being tested?
- Music Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2022to 29 Sep 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- IUI must be performed in the Reproductive Endocrinology and Infertility offices at Mayo Clinic in Rochester.
- IUI procedure must be on a weekday.
- IUI procedure is scheduled to be completed by a nurse in the REI Department.
Who cannot join
- Not English speaking.
- IUI procedure on a weekend day.
- IUI procedure is scheduled with an MD provider (known or expected to be difficult).
- Planned IUI procedure is cancelled prior to undergoing the procedure.
- The patient has a documented diagnosis of complete hearing loss or significant hearing impairment in both ears.
- The patient has previous participated or declined enrollment in the study during a prior IUI procedure.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: A Randomized Controlled Trial to Assess the Effect of Music Therapy on the Anxiety of Patients Undergoing Intrauterine Insemination
The purpose of this research is to learn if playing music in the room during an intrauterine insemination procedure decreases anxiety and pain for patients at the time of the procedure.
- Conditions
- Intrauterine Insemination
- Being tested
- Music Therapy
- Keywords
- Music Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music TherapyOther
Patient preferred artist or music genre to be playing from an iPad
| Study group | Role | What they receive |
|---|---|---|
| Music Therapy during the IUI procedure | Experimental | Subjects undergoing an intrauterine insemination (IUI) procedure will experience music therapy during the procedure. Receives: Other: Music Therapy |
| Standard of Care | No intervention | Subjects will receive standard of care for intrauterine insemination (IUI) procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in anxiety
Assessed using the 100-mm Visual Analogue Scale (VAS). The VAS line will be 100 mm long with no intermediate delineations. Each end will be marked with "No anxiety" on the left, and "Worst anxiety" on the right. Participants will identify their anxiety level by indicating a point on the line between each end. That point will be measured from the "No anxiety" end, and the number of millimeters will be reported as the pain score.
Measured: Baseline, during IUI procedure (approximately 20 minutes), after IUI procedure (approximately 5 minutes)
Secondary outcomes (2)
Change in pain score
Assessed using the Wong Baker Pain Rating. Subjects will place a mark on the face that best describes their pain level. Uses a 0-10 scale, where 0 represents "No pain" on the left, and 10 represents "Worst possible pain" on the right.
Measured: Baseline, during IUI procedure (approximately 20 minutes), after IUI procedure (approximately 5 minutes)
Pregnancy rate
Number of subjects to become pregnant
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 posted8 Aug 2022
- Study start3 Aug 2022
- Primary completion29 Sep 2023
- Study completion29 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intrauterine InseminationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandra (Ali) J. Ainsworth, Mayo Clinic
- Investigators
- Alessandra Ainsworth, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05492331
- Sponsor's protocol ID
- 22-006147
- Status last verified
- Nov 2023
- First submitted
- 5 Aug 2022
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baumgarten SC, Chen V, Ogle AJ, Fought AJ, Li Y, Ainsworth AJ. Effect of music on anxiety during intrauterine insemination: a randomized controlled trial. F S Rep. 2025 May 22;6(3):381-387. doi: 10.1016/j.xfre.2025.05.008. eCollection 2025 Sep.
PubMed 41054719
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Assess the Effect of Music Therapy on the Anxiety of Patients Undergoing Intrauterine Insemination
- ClinicalTrials.gov ID
- NCT05492331
- Acronym / sponsor ID
- 22-006147
- Conditions
- Intrauterine Insemination
- Keywords
- Music Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 3 Aug 2022 (actual)
- Primary completion
- 29 Sep 2023 (actual)
- Study completion
- 29 Sep 2023 (actual)
- First posted
- 8 Aug 2022 (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.
The purpose of this research is to learn if playing music in the room during an intrauterine insemination procedure decreases anxiety and pain for patients at the time of the procedure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music Therapy during the IUI procedure | Experimental | Other: Music TherapySubjects undergoing an intrauterine insemination (IUI) procedure will experience music therapy during the procedure. |
| Standard of Care | No intervention | –Subjects will receive standard of care for intrauterine insemination (IUI) procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- IUI must be performed in the Reproductive Endocrinology and Infertility offices at Mayo Clinic in Rochester.
- IUI procedure must be on a weekday.
- IUI procedure is scheduled to be completed by a nurse in the REI Department.
Key exclusion criteria (6 listed)
- Not English speaking.
- IUI procedure on a weekend day.
- IUI procedure is scheduled with an MD provider (known or expected to be difficult).
- Planned IUI procedure is cancelled prior to undergoing the procedure.
- The patient has a documented diagnosis of complete hearing loss or significant hearing impairment in both ears.
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 |
|---|---|---|
| Music TherapyPatient preferred artist or music genre to be playing from an iPad | Other | Music Therapy during the IUI procedure |
Primary outcome
Change in anxiety
Time frame: Baseline, during IUI procedure (approximately 20 minutes), after IUI procedure (approximately 5 minutes)
Assessed using the 100-mm Visual Analogue Scale (VAS). The VAS line will be 100 mm long with no intermediate delineations. Each end will be marked with "No anxiety" on the left, and "Worst anxiety" on the right. Participants will identify their anxiety level by indicating a point on the line between each end. That point will be measured from the "No anxiety" end, and the number of millimeters will be reported as the pain score.
2 secondary outcomes
Change in pain score
Time frame: Baseline, during IUI procedure (approximately 20 minutes), after IUI procedure (approximately 5 minutes)
Pregnancy rate
Time frame: 1 year
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 29 Nov 2023.
- Derived from this study: PubMed 41054719Baumgarten SC, Chen V, Ogle AJ, Fought AJ, Li Y, Ainsworth AJ. Effect of music on anxiety during intrauterine insemination: a randomized controlled trial. F S Rep. 2025 May 22;6(3):381-387. doi: 10.1016/j.xfre.2025.05.008. eCollection 2025 Sep.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Alessandra Ainsworth, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Therapy in people with Intrauterine Insemination, run by Mayo Clinic at 1 site in United States.
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 6 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 29 Nov 2023. 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 United States. 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?
Change in anxiety (time frame: Baseline, during IUI procedure (approximately 20 minutes), after IUI procedure (approximately 5 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05492331, which also lists 1 linked publication.
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 29 Nov 2023.