Total Knee ReplacementNCT07219329
The Feasibility of a Nurse-Initiated Weighted Blanket in Orthopedic Surgical Patients Undergoing Total Knee Arthroplasty
A study testing Weighted Blanket in people with Total Knee Replacement, run by NYU Langone Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Replacement
- What is being tested?
- Weighted Blanket
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2026to 6 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: The Feasibility of a Nurse-Initiated Weighted Blanket in Orthopedic Surgical Patients Undergoing Total Knee Arthroplasty: A Pilot Study
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.
- Conditions
- Total Knee Replacement
- Being tested
- Weighted Blanket
- Keywords
- anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weighted BlanketDevice
5lb weighted blanket
| Study group | Role | What they receive |
|---|---|---|
| Weighted blanket | Experimental | Participants will receive a weighted blanket in the preoperative holding room and in the Post-Anesthesia Care Unit (PACU) after surgery. Receives: Device: Weighted Blanket |
| Standard of care | No intervention | Participants will receive a non-weighted blanket in the preoperative holding room prior to and in the PACU after surgery per standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: PACU discharge (~1-3 hours post-surgery)
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.
Measured: PACU discharge (~1-3 hours post-surgery)
Secondary outcomes (5)
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.
Measured: Baseline (before blanket application), PACU discharge (~1-3 hours post-surgery)
Change in Numeric Pain Rating Scale (NPRS) score
Pain is assessed on the NPRS from 0 (No pain) to 10 (Severe pain).
Measured: Baseline (before blanket application), PACU discharge (~1-3 hours post-surgery)
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.
Measured: PACU discharge (~1-3 hours post-surgery)
Change in heart rate
Measured: Baseline (before blanket application), PACU discharge (~1-3 hours post-surgery)
Change in blood pressure
Measured: Baseline (before blanket application), PACU discharge (~1-3 hours post-surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2025
- Study start4 Feb 2026
- Primary completion6 Aug 2026
- Study completion6 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ReplacementStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diana Wong, MS, RN, CPAN, ONC, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07219329
- Sponsor's protocol ID
- 25-00571
- Status last verified
- Aug 2026
- First submitted
- 20 Oct 2025
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of a Nurse-Initiated Weighted Blanket in Orthopedic Surgical Patients Undergoing Total Knee Arthroplasty: A Pilot Study
- ClinicalTrials.gov ID
- NCT07219329
- Acronym / sponsor ID
- 25-00571
- Conditions
- Total Knee Replacement
- Keywords
- anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 4 Feb 2026 (actual)
- Primary completion
- 6 Aug 2026 (actual)
- Study completion
- 6 Aug 2026 (actual)
- First posted
- 21 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weighted blanket | Experimental | Device: Weighted BlanketParticipants will receive a weighted blanket in the preoperative holding room and in the Post-Anesthesia Care Unit (PACU) after surgery. |
| Standard of care | No intervention | –Participants will receive a non-weighted blanket in the preoperative holding room prior to and in the PACU after surgery per standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weighted Blanket5lb weighted blanket | Device | Weighted blanket |
Primary outcome
Time participants used weighted blanket
Time frame: 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
Time frame: 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.
5 secondary outcomes
Change in short Spielberger State-Trait Anxiety Inventory (SSTAI) score
Time frame: Baseline (before blanket application), PACU discharge (~1-3 hours post-surgery)
Change in Numeric Pain Rating Scale (NPRS) score
Time frame: Baseline (before blanket application), PACU discharge (~1-3 hours post-surgery)
Richmond Agitation-Sedation Scale (RASS) score
Time frame: PACU discharge (~1-3 hours post-surgery)
Change in heart rate
Time frame: Baseline (before blanket application), PACU discharge (~1-3 hours post-surgery)
Change in blood pressure
Time frame: Baseline (before blanket application), PACU discharge (~1-3 hours post-surgery)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diana Wong, MS, RN, CPAN, ONC principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weighted Blanket in people with Total Knee Replacement, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time participants used weighted blanket (time frame: PACU discharge (~1-3 hours post-surgery)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.