Weighted Blankets for IUD Insertion

Saint Luke's Health System

Status and phase: Invitation-only; Phase 1

Conditions: Intra-uterine Device Placement

Treatments: Other: 10-pound weighted lap-pad; Other: blanket

Study type: Interventional

Funder types: Other

Identifiers

NCT06969365

SLHS-24-088

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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54 participants in 2 patient groups

Weighted blanket

Experimental group

Description:

A weighted blanket will be applied to the patient during IUD placement

Treatment:

Other: 10-pound weighted lap-pad

Non-weighted blanket

Sham Comparator group

Description:

A non-weighted light blanket will be applied to patient during IUD insertion

Treatment:

Other: blanket