Skip to main content
OpenTrials
Completed

NCT Number: NCT05492331

A Study of Music Therapy to Support 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Intrauterine Insemination

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Music Therapy

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in pain score

    Time frame: 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.

  2. Pregnancy rate

    Time frame: 1 year

    Number of subjects to become pregnant

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 8, 2022
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.