Weighted Blankets for IUD Insertion
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 10-pound weighted lap-pad, blanket.
- Who it may be relevant to
- Registry conditions: Intra-uterine Device Placement. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Do Weighted Blankets Reduce Pain and Anxiety Associated With Gynecological Procedures?
Overview
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
- Other 10-pound weighted lap-pad
10-pound weighted lap pad will be placed over the patient's chest and shoulders - Other blanket
A simple, unweighted blanket will be applied to patients during IUD insertion
Primary outcome measures
- Visual Analog Scale - Anxiety [Time frame: At the conclusion of the procedure]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Saint Luke's Hospital — Kansas City
Publications
- Nguyen L, Lamarche L, Lennox R, Ramdyal A, Patel T, Black M, Mangin D. Strategies to Mitigate Anxiety and Pain in Intrauterine Device Insertion: A Systematic Review. J Obstet Gynaecol Can. 2020 Sep;42(9):1138-1146.e2. doi: 10.1016/j.jogc.2019.09.014. Epub 2019 Dec 25. PMID 31882291
Identifiers
NCT: NCT06969365 · SLHS-24-088