The Feasibility of a Nurse-Initiated Weighted Blanket in Orthopedic Surgical Patients Undergoing Total Knee Arthroplasty
Part of paid clinical trials in New York, New York.
- Sponsor
- NYU Langone Health
- Study ID
- NCT07219329
- Status
- Not Yet Recruiting
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Conditions
- Total Knee Replacement
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Weighted Blanket — DEVICE5lb weighted blanket
Study Details
The purpose of this study is to explore the acceptability and feasibility of weighted blankets in total knee replacement (TKR) patients. The study also aims to measure the difference in anxiety of adult orthopedic patients in need of total knee arthroplasty surgery who receive weighted blanket before and after surgery compared to those who receive a non-weighted blanket.
Key Dates
- Start date
- Nov 30, 2025
- Status verified
- Oct 2025
- Primary completion
- Jun 30, 2026
- Completion
- Jun 30, 2026
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Weighted blanketParticipants will receive a weighted blanket in the preoperative holding room and in the Post-Anesthesia Care Unit (PACU) after surgery.
- No Intervention: Standard of careParticipants will receive a non-weighted blanket in the preoperative holding room prior to and in the PACU after surgery per standard of care.
Primary Outcome Measure
Time participants used weighted blanket [ Time Frame: PACU discharge (~1-3 hours post-surgery) ]
Central Contacts
- Jennifer Withall, PhD, RN212-598-6127
- Kathleen Zavotsky, PhD, RN212-263-2055
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | - |
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