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Weighted Blankets for IUD Insertion

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

Status
Enrolling by invitation
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06969365
Enrollment
54
Registered
2025-05-13
Start date
2025-03-01
Completion date
2025-10-01
Last updated
2025-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intra-uterine Device Placement

Keywords

weighted blanket, gynecological procedure, IUD, anxiety

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.

Interventions

OTHER10-pound weighted lap-pad

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

OTHERblanket

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

Sponsors

Saint Luke's Health System
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Visual Analog Scale - AnxietyAt the conclusion of the procedurePatients will make a mark on a 100 mm line to indicate level of anxiety

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026