Weighted Blankets for IUD Insertion

Part of paid clinical trials in Kansas City, Missouri.

Sponsor
Saint Luke's Health System
Study ID
NCT06969365
Phase
PHASE1
Status
Enrolling By Invitation

Conditions

  • Intra-uterine Device Placement

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Mar 1, 2025
Status verified
May 2025
Primary completion
Aug 31, 2025
Completion
Oct 1, 2025

Study Design

Enrollment
54 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Weighted blanket
    A weighted blanket will be applied to the patient during IUD placement
  • Sham Comparator: Non-weighted blanket
    A non-weighted light blanket will be applied to patient during IUD insertion

Primary Outcome Measure

Visual Analog Scale - Anxiety [ Time Frame: At the conclusion of the procedure ]

Locations (1)

FacilityCityStateZIPSite coordinators
Saint Luke's HospitalKansas CityMissouri64111-

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