Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
PHASE1
54 participants
INTERVENTIONAL
2025-03-01
2025-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Weighted blanket
A weighted blanket will be applied to the patient during IUD placement
10-pound weighted lap-pad
10-pound weighted lap pad will be placed over the patient's chest and shoulders
Non-weighted blanket
A non-weighted light blanket will be applied to patient during IUD insertion
blanket
A simple, unweighted blanket will be applied to patients during IUD insertion
Interventions
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10-pound weighted lap-pad
10-pound weighted lap pad will be placed over the patient's chest and shoulders
blanket
A simple, unweighted blanket will be applied to patients during IUD insertion
Eligibility Criteria
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Inclusion Criteria
* age 18 years or older
* able to read and understand English and use a pen
Exclusion Criteria
* inability to remove weighted blanket
18 Years
FEMALE
Yes
Sponsors
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Saint Luke's Health System
OTHER
Responsible Party
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Principal Investigators
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Anna Guastello, BSN
Role: PRINCIPAL_INVESTIGATOR
Saint Luke's Health System
Locations
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Saint Luke's Hospital
Kansas City, Missouri, United States
Countries
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References
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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.
Other Identifiers
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SLHS-24-088
Identifier Type: -
Identifier Source: org_study_id
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