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

NCT07219329 | Not Yet Recruiting FDA Device

• 1 other identifier: 25-00571
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Knee Replacement

Keywords

anxiety

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

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

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

• Change in Numeric Pain Rating Scale (NPRS) score

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

• Richmond Agitation-Sedation Scale (RASS) score

  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)

Study Arms (2)

Weighted blanket

EXPERIMENTAL

Participants will receive a weighted blanket in the preoperative holding room and in the Post-Anesthesia Care Unit (PACU) after surgery.

Device: Weighted Blanket

Standard of care

NO INTERVENTION

Participants will receive a non-weighted blanket in the preoperative holding room prior to and in the PACU after surgery per standard of care.

Interventions

Weighted Blanket DEVICE

5lb weighted blanket

Weighted blanket

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Diana Wong, MS, RN, CPAN, ONC

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Withall, PhD, RN

CONTACT

212-598-6127; Jennifer.withall@nyulangone.org

Kathleen Zavotsky, PhD, RN

CONTACT

212-263-2055; Kathleen.zavotsky@nyulangone.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2025
• First Posted: October 21, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: October 21, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)