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OpenTrials
Enrolling by Invitation

NCT Number: NCT06969365

Weighted Blankets for IUD Insertion

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.

Enrolling by Invitation

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Key information

Conditions

Intra-uterine Device Placement Anxiety Disorders Mental Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Saint Luke's Hospital

Kansas City, Missouri, 64111, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

10-pound weighted lap-pad

Other

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

blanket

Other

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

Primary outcomes

  1. Visual Analog Scale - Anxiety

    Time frame: At the conclusion of the procedure

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

Sponsors and collaborators

Lead sponsor

Saint Luke's Health System

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 13, 2025
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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