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

NYU Langone Health logo

NYU Langone Health

Status

Not yet enrolling

Conditions

Total Knee Replacement

Treatments

Device: Weighted Blanket

Study type

Interventional

Funder types

Other

Identifiers

NCT07219329
25-00571

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 2 patient groups

Weighted blanket
Experimental group
Description:
Participants will receive a weighted blanket in the preoperative holding room and in the Post-Anesthesia Care Unit (PACU) after surgery.
Treatment:
Device: Weighted Blanket
Standard of care
No Intervention group
Description:
Participants will receive a non-weighted blanket in the preoperative holding room prior to and in the PACU after surgery per standard of care.

Trial contacts and locations

1

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Central trial contact

Jennifer Withall, PhD, RN; Kathleen Zavotsky, PhD, RN

Data sourced from clinicaltrials.gov

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