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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNYU Langone Health

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Weighted Blanket

    Device

    5lb weighted blanket

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Weighted blanketExperimental treatment 1 intervention
Group B: Standard of careNo intervention 0 interventions

Trial outcomes

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: