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 volunteersQualifiers
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
Single group
Treatments tested in this trial
Weighted Blanket
Device5lb weighted blanket
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
Secondary outcomes
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.
Change in Numeric Pain Rating Scale (NPRS) score
Pain is assessed on the NPRS from 0 (No pain) to 10 (Severe pain).
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.
Change in heart rate
Sponsors and contacts
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