Weighted Blankets for IUD Insertion

Phase 1Enrolling By InvitationNCT06969365

Saint Luke's Health System54 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Intra-uterine Device Placement

Interventions

10-pound weighted lap-padOTHER

10-pound weighted lap pad will be placed over the patient's chest and shoulders

blanketOTHER

A simple, unweighted blanket will be applied to patients during IUD insertion

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Saint Luke's Hospital

Kansas City, Missouri, United States

Outcomes

Primary Outcomes

Visual Analog Scale - Anxiety

Patients will make a mark on a 100 mm line to indicate level of anxiety

Time frame: At the conclusion of the procedure

Data from ClinicalTrials.gov

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