A Study of Music Therapy to Support Intrauterine Insemination

Intrauterine Insemination Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05492331
• Other study ID #: 22-006147
• Status: Completed
• Phase: N/A
• Start date: August 3, 2022
• Est. completion date: September 29, 2023

Study information

• Verified date: November 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 29, 2023
• Est. primary completion date: September 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Intrauterine Insemination

Intervention

Other:
• Music Therapy
Patient preferred artist or music genre to be playing from an iPad

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Pregnancy rate	Number of subjects to become pregnant	1 year

External Links

•   Mayo Clinic Clinical Trials