Intrauterine Insemination
Conditions
Keywords
Music Therapy
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.
Interventions
OTHERMusic Therapy
Patient preferred artist or music genre to be playing from an iPad
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed