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

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

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 Overview

• Status: Not yet recruiting
• Conditions: Total Knee Replacement
• Intervention / Treatment: Device: Weighted Blanket

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennifer Withall, PhD, RN; Phone Number: 212-598-6127; Email: Jennifer.withall@nyulangone.org
• Study Contact Backup: Name: Kathleen Zavotsky, PhD, RN; Phone Number: 212-263-2055; Email: Kathleen.zavotsky@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Weighted blanket; Participants will receive a weighted blanket in the preoperative holding room and in the Post-Anesthesia Care Unit (PACU) after surgery.	Device: Weighted Blanket; 5lb weighted blanket
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	PACU discharge (~1-3 hours post-surgery)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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.	PACU discharge (~1-3 hours post-surgery)
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)

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Diana Wong, MS, RN, CPAN, ONC, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: October 20, 2025
• First Submitted That Met QC Criteria: October 20, 2025
• First Posted (Estimated): October 21, 2025

Study Record Updates

• Last Update Posted (Estimated): October 21, 2025
• Last Update Submitted That Met QC Criteria: October 20, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: anxiety
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 25-00571

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Study participants did not provide consent for data sharing beyond the study team and institutional oversight. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes