A Study of Music Therapy to Support Intrauterine Insemination

Sponsor

Mayo Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT05492331

Collaborator

(none)

Enrollment

Location

Arms

8.9

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intrauterine Insemination	Other: Music Therapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

62 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Aug 3, 2022

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator: Alessandra Ainsworth, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

Alessandra (Ali) J. Ainsworth, Principal Investigator, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT05492331

Other Study ID Numbers:

22-006147

First Posted:

Aug 8, 2022

Last Update Posted:

Aug 8, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Alessandra (Ali) J. Ainsworth, Principal Investigator, Mayo Clinic

Music Therapy

Study Results

No Results Posted as of Aug 8, 2022