Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07219329

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Total Knee Replacement Anxiety Disorders Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Weighted blanket

Device

5lb weighted blanket

Primary outcomes

  1. Time participants used weighted blanket

    Time frame: 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.

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

    Time frame: 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 outcomes

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

    Time frame: 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.

  2. Change in Numeric Pain Rating Scale (NPRS) score

    Time frame: 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).

  3. Richmond Agitation-Sedation Scale (RASS) score

    Time frame: 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.

  4. Change in heart rate

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

  5. Change in blood pressure

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer Withall, PhD, RN

CONTACT

[email protected]

212-598-6127

Kathleen Zavotsky, PhD, RN

CONTACT

[email protected]

212-263-2055

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 21, 2025
Registry last updated
Oct 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.