Weighted Blankets for IUD Placement
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether a small, weighted blanket can reduce anxiety and pain during the placement of an intrauterine device (IUD) in a clinic setting. Participants will have either a weighted blanket or a non-weighted light blanket placed over them during the procedure. This trial suits individuals scheduled for an IUD placement who can read and understand English. The aim is to determine if the weighted blanket makes the procedure more comfortable. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to experience this innovative approach.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications.
What prior data suggests that using weighted blankets is safe for anxiety reduction during IUD placement?
Research has shown that weighted blankets are generally safe for use and often help with anxiety and sleep problems. No major reports of harm have emerged, and most people find them comfortable. In this trial, the weighted blanket is placed on the chest and shoulders, similar to home use for comfort.
This trial is in an early phase, marking the first step in studying this specific use. Early phase trials focus on safety, carefully monitoring for any issues. Since weighted blankets are already used in everyday life, this study aims to confirm their safety in this new setting.12345Why are researchers excited about this trial?
Researchers are excited about using weighted blankets during IUD placement because they offer a novel, non-pharmacological way to potentially reduce anxiety and discomfort. Unlike typical pain management methods that rely on medications, weighted blankets provide a comforting pressure that might help patients feel more relaxed and secure. This approach could be an appealing alternative for those seeking a drug-free option to enhance their IUD insertion experience.
What evidence suggests that weighted blankets are effective for reducing anxiety during IUD placement?
Research has shown that weighted blankets might help lower anxiety and pain. One study found that people felt less anxious using a 10-pound weighted lap pad during IUD placement compared to a regular blanket. In this trial, participants will join either a weighted blanket group or a non-weighted blanket group during IUD insertion. The deep pressure from the weighted blanket is believed to have a calming effect, similar to a comforting hug. Although more research is needed for confirmation, these early results are encouraging. Weighted blankets have also been used in other situations to help people relax and reduce stress.12456
Who Is on the Research Team?
Anna Guastello, BSN
Principal Investigator
Saint Luke's Health System
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo IUD placement with either a weighted or non-weighted blanket
Follow-up
Participants are monitored for anxiety and pain levels immediately after the procedure
What Are the Treatments Tested in This Trial?
Interventions
- Weighted Blankets
Find a Clinic Near You
Who Is Running the Clinical Trial?
Saint Luke's Health System
Lead Sponsor