Intrauterine Device Placement
Conditions
Keywords
intrauterine device
Brief summary
The goal of this randomized controlled trial is to learn if placing a vibrating device at the umbilicus during insertion of intrauterine device (IUD) decreases perceived pain during the procedure. The main question it aims to answer is: Does applying a vibrating device to the umbilicus during IUD insertion significantly reduce perceived pain compared to standard of care? Researchers will compare pain scores during IUD insertion among patients who received the vibrating device at the umbilicus and those who did not. Participants will be randomly assigned to receive a vibrating device placed on the umbilicus during IUD insertion or not. All participants will be able to use standard of care pain control measures during the IUD insertion procedure as desired, even if randomized to receive the vibrating device. Participants will complete a pre-procedure survey and will report their pain on a scale of 1-100 at various points during the IUD insertion procedure. Participants who received the vibrating device will also complete a post-procedure survey.
Interventions
DEVICEPeriumbilical Vibration during Intrauterine Device Placement
Participants will be randomly assigned to receive a vibrating device placed on the belly button during IUD insertion or not. All participants will be able to use standard of care pain control measures during the IUD insertion procedure as desired, even if randomized to receive the vibrating device.
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older * Capable of providing informed consent * Scheduled for IUD insertion at either Duke 1J gynecology clinic or Family Planning clinic * English-speaking
Exclusion criteria
* Currently pregnant * Planned use of IV sedation during IUD placement * Inability to provide informed consent due to disability or language barrier
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain score | Pain will be assessed using a 100-point Visual Analog Scale (VAS) at multiple time points during and after the procedure (pre-procedure, with speculum placement, with tenaculum placement, immediately after uterine sound, immediately after IUD placement, | Perceived pain will be assessed using a 100-point visual analog scale (VAS). The VAS ranges from 0 to 100 with the lower score indicating less pain and the higher score indicating greater pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction of Vibration Therapy | 15 minutes post-procedure | Participants in the intervention arm will complete a post-procedure questionnaire evaluating satisfaction with the vibration therapy. |
| Acceptability of Vibration Therapy | 15 minutes post-procedure | Participants in the intervention arm will complete a post-procedure questionnaire evaluating acceptability of the vibration therapy. |
Countries
United States
Contacts
CONTACTMadeline Thornton, MD, MPH
PRINCIPAL_INVESTIGATORBeverly Gray, MD
Duke Health
Outcome results
None listed