NCT06969365

Weighted Blankets for IUD Insertion

Do Weighted Blankets Reduce Pain and Anxiety Associated With Gynecological Procedures?

• Status: Enrolling By Invitation
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Saint Luke's Health System · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

Patients scheduled for an IUD placement in this specific outpatient clinic will be approached by the study nurse to gauge interest in participating. Consented patients will be randomized to either receive a weighted blanket or a non-weighted blanket. Patients will rate their anxiety on a 100 mm visual-analog scale and pain on a 0-10 verbal scale.

Conditions

• Intra-uterine Device Placement

Interventions

Type	Name	Description
OTHER	10-pound weighted lap-pad	10-pound weighted lap pad will be placed over the patient's chest and shoulders
OTHER	blanket	A simple, unweighted blanket will be applied to patients during IUD insertion

Timeline

• Start date: 2025-03-01
• Primary completion: 2025-08-31
• Completion: 2025-10-01
• First posted: 2025-05-13
• Last updated: 2025-05-13

Locations

1 site across 1 country: United States