A Study of Music Therapy to Support Intrauterine Insemination

NCT05492331 | Completed

• 1 other identifier: 22-006147
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Intrauterine Insemination

Keywords

Music Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in pain score

  Baseline, during IUI procedure (approximately 20 minutes), after IUI procedure (approximately 5 minutes)

• Pregnancy rate

  1 year

Study Arms (2)

Music Therapy during the IUI procedure

EXPERIMENTAL

Subjects undergoing an intrauterine insemination (IUI) procedure will experience music therapy during the procedure.

Other: Music Therapy

Standard of Care

NO INTERVENTION

Subjects will receive standard of care for intrauterine insemination (IUI) procedure.

Interventions

Music Therapy OTHER

Patient preferred artist or music genre to be playing from an iPad

Music Therapy during the IUI procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Baumgarten SC, Chen V, Ogle AJ, Fought AJ, Li Y, Ainsworth AJ. Effect of music on anxiety during intrauterine insemination: a randomized controlled trial. F S Rep. 2025 May 22;6(3):381-387. doi: 10.1016/j.xfre.2025.05.008. eCollection 2025 Sep.

  PMID: 41054719 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Music Therapy

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Alessandra Ainsworth, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 5, 2022
• First Posted: August 8, 2022
• Study Start: August 3, 2022
• Primary Completion: September 29, 2023
• Study Completion: September 29, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)