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Not yet recruiting NCT07219329

The Feasibility of a Nurse-Initiated Weighted Blanket in Orthopedic Surgical Patients Undergoing Total Knee Arthroplasty

No phase Interventional Total Knee Replacement

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: Weighted Blanket.
Who it may be relevant to
Registry conditions: Total Knee Replacement. Basic parameters: from 18 years · All.
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

The Feasibility of a Nurse-Initiated Weighted Blanket in Orthopedic Surgical Patients Undergoing Total Knee Arthroplasty: A Pilot Study

Overview

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.

Interventions

  • Device Weighted Blanket
    5lb weighted blanket

Primary outcome measures

  • Time participants used weighted blanket [Time frame: PACU discharge (~1-3 hours post-surgery)]
  • Number of participants who would use a weighted blanket in the future [Time frame: PACU discharge (~1-3 hours post-surgery)]
Secondary outcome measures (5)
  • Change in short Spielberger State-Trait Anxiety Inventory (SSTAI) score [Time frame: Baseline (before blanket application), PACU discharge (~1-3 hours post-surgery)]
  • Change in Numeric Pain Rating Scale (NPRS) score [Time frame: Baseline (before blanket application), PACU discharge (~1-3 hours post-surgery)]
  • Richmond Agitation-Sedation Scale (RASS) score [Time frame: PACU discharge (~1-3 hours post-surgery)]
  • Change in heart rate [Time frame: Baseline (before blanket application), PACU discharge (~1-3 hours post-surgery)]
  • Change in blood pressure [Time frame: Baseline (before blanket application), PACU discharge (~1-3 hours post-surgery)]

Eligibility criteria

Inclusion criteria

  • Adults aged 18 years and older
  • Adults undergoing elective total knee arthroplasty at NYU Langone Orthopedic Hospital.
  • Adults who are scheduled to receive spinal anesthesia.
  • Subjects with a planned same day discharge to home from the PACU

Exclusion criteria

  • cognitive disability that would interfere with their ability to complete the study's pre and post assessments (e.g. dementia, non-verbal)
  • subject disclosed history of pre-existing anxiety disorder, claustrophobia, epilepsy, respiratory conditions (e.g. obstructive sleep apnea (OSA), asthma), skin conditions (e.g. pressure injury), which are contradictions for weighted blanket.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • NYU Langone Health — New York

Identifiers

NCT: NCT07219329 · 25-00571

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗