Weighted Blankets for IUD Placement

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: Saint Luke's Health System

Disqualifiers: Inability to consent, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

54 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Anna Guastello, BSN

Principal Investigator

Saint Luke's Health System

Eligibility Criteria

This trial is for individuals undergoing IUD placement who may experience anxiety or pain during the procedure. Specific eligibility criteria are not provided, but typically participants would need to be of reproductive age and seeking an IUD insertion.

Inclusion Criteria

Able to read and understand English and use a pen

I am scheduled to have an IUD placed.

Exclusion Criteria

I cannot remove a weighted blanket by myself.

I am unable to give consent by myself.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants undergo IUD placement with either a weighted or non-weighted blanket

1 day

1 visit (in-person)

Follow-up

Participants are monitored for anxiety and pain levels immediately after the procedure

1 day

1 visit (in-person)

Treatment Details

Interventions

• Weighted Blankets

Trial Overview The study is testing whether a 10-pound weighted blanket placed over the chest and shoulders can reduce anxiety and pain in patients having an IUD inserted at an outpatient clinic.

Participant Groups

Group I: Weighted blanket Experimental Treatment 1 Intervention

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

Group II: Non-weighted blanket Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Saint Luke's Health System

Lead Sponsor

Trials

42

Recruited

12,600+