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 — DEVICE
    5lb 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 blanket
    Participants will receive a weighted blanket in the preoperative holding room and in the Post-Anesthesia Care Unit (PACU) after surgery.
  • No Intervention: Standard of care
    Participants 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

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

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