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

Not Applicable

Not yet recruiting

• Conditions: Total Knee Replacement

• Registration Number: NCT07219329
• Lead Sponsor: NYU Langone Health

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-20
• Study First Submitted QC: 2025-10-20
• Last Update Submitted: 2025-10-20
• Study First Posted: 2025-10-21
• Last Update Posted: 2025-10-21
• Study Start: 2025-11-01
• Primary Completion: 2026-06
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Time participants used weighted blanket	PACU discharge (~1-3 hours post-surgery)	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.
Number of participants who would use a weighted blanket in the future	PACU discharge (~1-3 hours post-surgery)	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.

Secondary Outcome Measures

Name	Time	Method
Change in short Spielberger State-Trait Anxiety Inventory (SSTAI) score	Baseline (before blanket application), PACU discharge (~1-3 hours post-surgery)	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.
Change in Numeric Pain Rating Scale (NPRS) score	Baseline (before blanket application), PACU discharge (~1-3 hours post-surgery)	Pain is assessed on the NPRS from 0 (No pain) to 10 (Severe pain).
Richmond Agitation-Sedation Scale (RASS) score	PACU discharge (~1-3 hours post-surgery)	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.
Change in heart rate	Baseline (before blanket application), PACU discharge (~1-3 hours post-surgery)
Change in blood pressure	Baseline (before blanket application), PACU discharge (~1-3 hours post-surgery)

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States