Weighted Blankets for IUD Insertion

Phase 1

• Conditions: Intra-uterine Device Placement

• Registration Number: NCT06969365
• Lead Sponsor: Saint Luke's Health System

Brief 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.

Study Timeline

• Study Start: 2025-03-01
• Study First Submitted: 2025-04-23
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-07
• Last Update Submitted: 2025-05-07
• Study First Posted: 2025-05-13
• Last Update Posted: 2025-05-13
• Primary Completion: 2025-08-31
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 54

Inclusion Criteria

• scheduled for IUD placement
• age 18 years or older
• able to read and understand English and use a pen

Exclusion Criteria

• inability to consent
• inability to remove weighted blanket

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale - Anxiety	At the conclusion of the procedure	Patients will make a mark on a 100 mm line to indicate level of anxiety

Trial Locations

Locations (1)

Saint Luke's Hospital; 🇺🇸 Kansas City, Missouri, United States