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

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• Anxiety Disorders 4,868

Keywords

• anxiety

Anxiety Disorders

4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.

This study's enrollment of 30 is below the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.

Lead sponsor

NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.

Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.

Study arms

• 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

• 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.

Interventions

• DeviceWeighted Blanket

  5lb weighted blanket

Primary outcomes

1. 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.

   Time frame: PACU discharge (~1-3 hours post-surgery)

2. 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.

   Time frame: PACU discharge (~1-3 hours post-surgery)

Secondary outcomes

1. 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.

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

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

   Pain is assessed on the NPRS from 0 (No pain) to 10 (Severe pain).

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

3. 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.

   Time frame: PACU discharge (~1-3 hours post-surgery)

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)

Individual participant data

Plan to share: No — 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.