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

Mayo Clinic1 site in 1 country100 target enrollmentAugust 3, 2022

ConditionsIntrauterine Insemination

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Intrauterine Insemination
Sponsor: Mayo Clinic
Enrollment: 100
Locations: 1
Primary Endpoint: Change in anxiety
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 3, 2022

End Date

September 29, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Mayo Clinic

Responsible Party

Principal Investigator

Alessandra (Ali) J. Ainsworth

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.