Total Knee Replacement
Conditions
Keywords
anxiety
Brief summary
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.
Interventions
DEVICEWeighted Blanket
5lb weighted blanket
Sponsors
NYU Langone Health
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time participants used weighted blanket | 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. |
| Number of participants who would use a weighted blanket in the future | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in short Spielberger State-Trait Anxiety Inventory (SSTAI) score | 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. |
| Change in Numeric Pain Rating Scale (NPRS) score | 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). |
| Richmond Agitation-Sedation Scale (RASS) score | 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. |
| Change in heart rate | Baseline (before blanket application), PACU discharge (~1-3 hours post-surgery) | — |
| Change in blood pressure | Baseline (before blanket application), PACU discharge (~1-3 hours post-surgery) | — |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDiana Wong, MS, RN, CPAN, ONC
NYU Langone Health
Outcome results
None listed