A Study of Music Therapy to Support Intrauterine Insemination

Not Applicable

Completed

• Conditions: Intrauterine Insemination
• Interventions: Other: Music Therapy

• Registration Number: NCT05492331
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2022-08-03
• Study First Submitted: 2022-08-05
• Study First Submitted QC: 2022-08-05
• Study First Posted: 2022-08-08
• Primary Completion: 2023-09-29
• Study Completion: 2023-09-29
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Music Therapy during the IUI procedure	Music Therapy	Subjects undergoing an intrauterine insemination (IUI) procedure will experience music therapy during the procedure.

Primary Outcome Measures

Name	Time	Method
Change in anxiety	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.

Secondary Outcome Measures

Name	Time	Method
Change in pain score	Baseline, during IUI procedure (approximately 20 minutes), after IUI procedure (approximately 5 minutes)	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.
Pregnancy rate	1 year	Number of subjects to become pregnant

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States