Weighted Blankets for IUD Insertion
Part of paid clinical trials in Kansas City, Missouri.
- Sponsor
- Saint Luke's Health System
- Study ID
- NCT06969365
- Phase
- PHASE1
- Status
- Enrolling By Invitation
Conditions
- Intra-uterine Device Placement
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- 10-pound weighted lap-pad — OTHER10-pound weighted lap pad will be placed over the patient's chest and shoulders
- blanket — OTHERA simple, unweighted blanket will be applied to patients during IUD insertion
Study Details
When having an intrauterine device placed in an outpatient clinic, patients frequently feel anxiety related to the procedure. This study is designed to determine if the use of a small, weighted blanket, placed over the patient's chest and shoulders, would help decrease that anxiety, as well as pain related to the procedure.
Key Dates
- Start date
- Mar 1, 2025
- Status verified
- May 2025
- Primary completion
- Aug 31, 2025
- Completion
- Oct 1, 2025
Study Design
- Enrollment
- 54 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: Weighted blanketA weighted blanket will be applied to the patient during IUD placement
- Sham Comparator: Non-weighted blanketA non-weighted light blanket will be applied to patient during IUD insertion
Primary Outcome Measure
Visual Analog Scale - Anxiety [ Time Frame: At the conclusion of the procedure ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Saint Luke's Hospital | Kansas City | Missouri | 64111 | - |
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