Weighted Blanket for Anxiety in Total Knee Arthroplasty

JW
KZ
Overseen ByKathleen Zavotsky, PhD, RN
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: NYU Langone Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether weighted blankets can reduce anxiety in patients undergoing total knee replacement surgery. The goal is to determine if using these blankets before and after surgery calms nerves more effectively than regular blankets. Participants will receive either a weighted blanket or a standard blanket to compare the effects. This trial suits adults scheduled for knee surgery at NYU Langone who do not have anxiety disorders or conditions like asthma that might make using a weighted blanket uncomfortable. As an unphased trial, it offers participants the opportunity to contribute to innovative research that could enhance surgical experiences.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that weighted blankets are safe for anxiety in total knee arthroplasty patients?

Research has shown that weighted blankets are generally safe to use. In past studies, participants using weighted blankets experienced reduced anxiety. For instance, one study found that individuals using a weighted blanket felt less anxious before surgery compared to those using a regular blanket. Another study demonstrated that a 15-pound weighted blanket helped reduce feelings of chronic pain without causing harm.

Weighted blankets are already popular for relaxation and comfort. They are often considered safe because they don't involve medication or medical procedures. These studies have not reported significant negative side effects, suggesting that weighted blankets might be well-tolerated by most people, including those undergoing surgery.12345

Why are researchers excited about this trial?

Researchers are excited about using weighted blankets for anxiety in total knee arthroplasty because they offer a non-drug alternative to manage anxiety, which is typically addressed with medications like benzodiazepines. Unlike these medications, weighted blankets work by applying deep pressure stimulation, which can have a calming effect on the nervous system without the risk of medication side effects. This method could provide a comforting, drug-free way to alleviate anxiety both before and after surgery, potentially enhancing patient comfort and recovery experience.

What evidence suggests that a weighted blanket is effective for reducing anxiety in total knee arthroplasty patients?

This trial will compare the use of a weighted blanket with standard care in patients undergoing total knee arthroplasty. Studies have shown that weighted blankets can reduce anxiety in surgical patients. One study found that patients using a weighted blanket felt significantly less anxious before surgery than those using a regular blanket. The gentle pressure from the weighted blanket appears to have a calming effect, enhancing feelings of security. Another study suggested that weighted blankets might also reduce chronic pain by applying gentle pressure. While additional research is beneficial, these findings suggest that weighted blankets could be a promising option for reducing anxiety and discomfort in surgical settings.24567

Who Is on the Research Team?

DW

Diana Wong, MS, RN, CPAN, ONC

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for adults who are about to undergo or have recently had total knee replacement surgery and are experiencing anxiety. There's no detailed exclusion criteria provided, but typically, participants should be in stable health aside from their knee condition.

Inclusion Criteria

I am scheduled to go home the same day I leave the recovery unit.
I am 18 years old or older.
I am an adult scheduled for knee replacement surgery at NYU Langone Orthopedic Hospital.
See 1 more

Exclusion Criteria

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
I do not have a cognitive disability that prevents me from completing study tasks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative

Participants receive either a weighted or non-weighted blanket in the preoperative holding room

1 day
1 visit (in-person)

Postoperative

Participants receive either a weighted or non-weighted blanket in the Post-Anesthesia Care Unit (PACU) after surgery

1-3 hours
1 visit (in-person)

Follow-up

Participants are monitored for changes in anxiety and pain levels after surgery

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Weighted Blanket
Trial Overview The study is testing the use of weighted blankets on patients undergoing total knee arthroplasty to see if they help reduce anxiety levels compared to non-weighted blankets. Patients will receive either a weighted or non-weighted blanket before and after surgery.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Weighted blanketExperimental Treatment1 Intervention
Group II: Standard of careActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+

Citations

Weighted Blanket for Anxiety in Total Knee ArthroplastyThe purpose of this study is to explore the acceptability and feasibility of weighted blankets in total knee replacement (TKR) patients.
Effect of Weighted Blanket Versus Traditional Practices on ...Patients in the intervention group had significantly lower preoperative anxiety scores (mean [SD] = 26.28 [25.75]) compared to the control group (mean [SD] = ...
3.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/38804725/
Effect of Weighted Blanket Versus Traditional Practices on ...These results suggest that weighted blankets reduce preoperative anxiety in adult patients. Keywords: anxiety; deep touch pressure (DTP); pain; sympathetic ...
Nurse-Led Weighted Blanket Study for Knee Replacement Surgery ...Clinical trial examining the use of weighted blankets to improve comfort and reduce anxiety for patients undergoing knee replacement surgery at NYU Langone
Widespread Pressure Delivered by a Weighted Blanket ...This randomized-controlled trial showed that a 15-lb weighted blanket produced significantly greater reductions in broad perceptions of chronic pain.
The Feasibility of a Nurse-Initiated Weighted Blanket in ...The purpose of this study is to explore the acceptability and feasibility of weighted blankets in total knee replacement (TKR) patients. The ...
The Feasibility of a Nurse-Initiated Weighted Blanket inThe purpose of this study is to explore the acceptability and feasibility of weighted blankets in total knee replacement (TKR) patients.
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security