A Study of Music Therapy to Support Intrauterine Insemination

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.

Study Overview

• Status: Completed
• Conditions: Intrauterine Insemination
• Intervention / Treatment: Other: Music Therapy

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah Baumgarten, MD, PhD; Phone Number: 507-284-9792; Email: baumgarten.sarah@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Alessandra Ainsworth, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2022
• Primary Completion (Actual): September 29, 2023
• Study Completion (Actual): September 29, 2023

Study Registration Dates

• First Submitted: August 5, 2022
• First Submitted That Met QC Criteria: August 5, 2022
• First Posted (Actual): August 8, 2022

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Music Therapy
• Other Study ID Numbers: 22-006147

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No