A Study of Music Therapy to Support Intrauterine Insemination

NCT ID: NCT05492331

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-03

Study Completion Date

2023-09-29

Brief Summary

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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.

Detailed Description

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Conditions

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Intrauterine Insemination

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Music Therapy during the IUI procedure

Subjects undergoing an intrauterine insemination (IUI) procedure will experience music therapy during the procedure.

Group Type EXPERIMENTAL

Music Therapy

Intervention Type OTHER

Patient preferred artist or music genre to be playing from an iPad

Standard of Care

Subjects will receive standard of care for intrauterine insemination (IUI) procedure.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Music Therapy

Patient preferred artist or music genre to be playing from an iPad

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Alessandra (Ali) J. Ainsworth

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alessandra Ainsworth, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 41054719 (View on PubMed)

Related Links

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Other Identifiers

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22-006147

Identifier Type: -

Identifier Source: org_study_id