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

N/ACompletedNCT07219329

NYU Langone Health30 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Total Knee Replacement

Interventions

Weighted BlanketDEVICE

5lb weighted blanket

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Adults aged 18 years and older 2. Adults undergoing elective total knee arthroplasty at NYU Langone Orthopedic Hospital. 3. Adults who are scheduled to receive spinal anesthesia. 4. Subjects with a planned same day discharge to home from the PACU Exclusion Criteria: 1. cognitive disability that would interfere with their ability to complete the study's pre and post assessments (e.g. dementia, non-verbal) 2. 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.

Locations (1)

NYU Langone Health

New York, New York, United States

Outcomes

Primary Outcomes

Time participants used weighted blanket

Outcome measure assessed via investigator-created Weighted Blanket Feasibility Question in Post-Anesthesia Care Unit (PACU). Question asks "How long would you estimate that you used the weighted blanket?" Patient-reported estimate in minutes.

Time frame: PACU discharge (~1-3 hours post-surgery)

Number of participants who would use a weighted blanket in the future

Outcome measure via investigator-created Weighted Blanket Acceptability Question in PACU. The question asks the participant "If you were offered a weighted blanket in the future, would you choose to use it?" with choices of "yes", "no", and "unsure" and then asked to explain their choice.

Time frame: PACU discharge (~1-3 hours post-surgery)

Secondary Outcomes

Change in short Spielberger State-Trait Anxiety Inventory (SSTAI) score

The STAI-5 consists of 5 items relating to anxiety, each item is scored on a 4-point scale. Scores range from 5 to 20, with higher scores indicating more anxiety.

Time frame: Baseline (before blanket application), PACU discharge (~1-3 hours post-surgery)

Change in Numeric Pain Rating Scale (NPRS) score

Pain is assessed on the NPRS from 0 (No pain) to 10 (Severe pain).

Time frame: Baseline (before blanket application), PACU discharge (~1-3 hours post-surgery)

Richmond Agitation-Sedation Scale (RASS) score

The RASS consists of a 10-point scale.. Positive scores indicate agitation, with +4 being the most severe (combative), and negative scores indicate sedation, with -5 being the deepest level of sedation (unarousable). A score of 0 indicates the patient is alert and calm.

Time frame: PACU discharge (~1-3 hours post-surgery)

Data from ClinicalTrials.gov

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