A Study of Music Therapy to Support Intrauterine Insemination

Study Overview
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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.

Official Title
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A Randomized Controlled Trial to Assess the Effect of Music Therapy on the Anxiety of Patients Undergoing Intrauterine Insemination

Conditions
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Intrauterine Insemination

Intervention / Treatment
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* Other: Music Therapy


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music Therapy during the IUI procedure<br>Subjects undergoing an intrauterine insemination (IUI) procedure will experience music therapy during the procedure. | Other: Music Therapy<br>* Patient preferred artist or music genre to be playing from an iPad<br>|
| No Intervention: Standard of Care<br>Subjects will receive standard of care for intrauterine insemination (IUI) procedure. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, during IUI procedure (approximately 20 minutes), after IUI procedure (approximately 5 minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, during IUI procedure (approximately 20 minutes), after IUI procedure (approximately 5 minutes) | 
| Pregnancy rate | Number of subjects to become pregnant | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Music Therapy