A Randomized Controlled Trial to Assess the Effect of Music Therapy on the Anxiety of Patients Undergoing Intrauterine Insemination
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Intrauterine Insemination
- Sponsor
- Mayo Clinic
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Change in anxiety
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Alessandra (Ali) J. Ainsworth
Principal Investigator
Mayo Clinic
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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
- Change in pain score(Baseline, during IUI procedure (approximately 20 minutes), after IUI procedure (approximately 5 minutes))
- Pregnancy rate(1 year)