Weighted Blankets for Recovery from Heart Procedures

Overseen By Cynthia Smith

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: PTSD, Claustrophobia, Seizures, Asthma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a weighted blanket (a therapeutic blanket providing deep pressure stimulation) can reduce agitation after heart procedures such as cardiac catheterization and electrophysiology. The goal is to determine if these blankets can calm patients, reducing the need for extra sedation and potentially lowering the risk of complications. Individuals who have undergone a heart procedure and will rest in a specific recovery unit (cardiac PACU) for more than 2 hours might be suitable candidates. However, those with conditions like severe asthma, PTSD, or sleep apnea using CPAP, among others, may not qualify. As an unphased trial, this study offers a unique opportunity to explore innovative ways to improve recovery comfort and outcomes.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to consult with the trial coordinators or your doctor for guidance.

What prior data suggests that weighted blankets are safe for use in post-procedural recovery?

Research has shown that weighted blankets are generally safe to use. No serious problems have been reported with their use. In fact, one study found that they can help reduce anxiety, which is a bonus. Another study showed that using a 30-pound weighted blanket while lying down is safe, based on checks of vital signs like heart rate and breathing. No evidence suggests these blankets are unsafe. They seem to be well-tolerated and might make recovery more comfortable after heart procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using weighted blankets for recovery after heart procedures because they offer a non-invasive, comforting way to help patients feel more relaxed and possibly reduce anxiety. Unlike traditional medications or therapies used post-surgery, such as pain relievers and sedatives, weighted blankets work by providing gentle pressure that mimics a comforting hug, which can help soothe the nervous system. This approach could potentially enhance recovery without the side effects associated with pharmaceuticals, making it a unique and promising alternative.

What evidence suggests that weighted blankets are effective for reducing agitation after heart procedures?

Research has shown that weighted blankets, which participants in this trial may receive, can reduce anxiety and have a calming effect. They apply gentle pressure, activating the part of the nervous system that promotes relaxation. Studies have found that tools like weighted blankets effectively lower stress levels. Some users of weighted blankets also experienced better sleep, with a slight increase in sleep duration. These findings suggest that weighted blankets might help calm patients after heart procedures by reducing restlessness. ^{1 2 4 6 7}

Who Is on the Research Team?

Brian Armstrong, RN

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for pediatric cardiology patients weighing between 40 and 220 pounds who are recovering from cardiac catheterization or electrophysiology procedures. They must plan to recover in the cardiac PACU for over 2 hours. It's not for those with severe asthma, recent open heart surgery, certain muscular disorders, skin issues, severe pulmonary hypertension, PTSD, claustrophobia, uncontrolled seizures, specific lung diseases or those needing immediate post-procedure tests.

Inclusion Criteria

Duration of recovery planned for 11th floor cardiac PACU

I will be on bed rest for more than 2 hours after my procedure.

I am undergoing a heart procedure involving catheters.

Exclusion Criteria

I weigh less than 40 pounds.

I weigh more than 220 pounds.

I need heart and lung checks right after surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Post-procedural Care

Participants receive care in the PACU with the use of weighted blankets to reduce agitation and sedation needs

up to 6 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the use of weighted blankets

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Weighted blanket

Trial Overview The study is testing if using a weighted blanket after heart-related procedures can calm patients more effectively than usual care without blankets. The goal is to see if this leads to less need for extra sedation and fewer complications related to blood vessels after the procedure.

How Is the Trial Designed?

Group I: Weighted blanket Experimental Treatment 1 Intervention

Group II: Standard of Care Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Published Research Related to This Trial

In a randomized controlled trial involving 58 patients recovering from cardiac surgery, those who received a 20-minute massage therapy session reported significant reductions in pain, anxiety, and tension compared to those who received standard care.

The positive feedback from patients suggests that incorporating massage therapy into postoperative care could enhance recovery for cardiovascular surgical patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of massage therapy on pain, anxiety, and tension in cardiac surgical patients: a pilot study. Cutshall, SM., Wentworth, LJ., Engen, D., et al.[2022]

Hammocks and cradles provide emotional soothing and may have significant effects on skin and deep body components, suggesting they could play a role in overall health and wellness.

These devices, while simple in structure, have the potential to transform health care practices in areas like acute care, rehabilitation, and home care due to their physiological benefits and possible economic and logistical advantages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study of cradle and pendulum motion for applications to health care. Frisina, W.[2019]

Massage therapy significantly improved sleep quality and reduced fatigue in patients recovering from cardiopulmonary artery bypass graft surgery, as evidenced by evaluations over three days.

In a study of 40 patients, those receiving massage therapy reported better sleep and less fatigue compared to a control group, highlighting the potential benefits of massage in postoperative recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of massage therapy on sleep quality after coronary artery bypass graft surgery. Nerbass, FB., Feltrim, MI., Souza, SA., et al.[2022]

A study involving 120 patients who underwent coronary artery bypass graft (CABG) surgery found that both Benson relaxation (BR) and progressive muscle relaxation (PMR) techniques significantly improved overall sleep quality after a four-week intervention.

Patients in the BR and PMR groups experienced better subjective sleep quality and habitual sleep efficiency compared to a control group, indicating that these relaxation techniques can be beneficial for sleep in post-surgery recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Benson and progressive muscle relaxation techniques on sleep quality after coronary artery bypass graft: A randomized controlled trial. Bagheri, H., Moradi-Mohammadi, F., Khosravi, A., et al.[2021]

In a study of 72 patients who underwent coronary artery bypass surgery, those who received Swedish massage therapy showed a significant improvement in mood compared to those who only received routine care.

Massage therapy, administered in four 20-minute sessions shortly after surgery, is an effective and low-cost complementary treatment that can help alleviate psychological distress in post-operative heart surgery patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of massage therapy on the mood of patients after open-heart surgery. Babaee, S., Shafiei, Z., Sadeghi, MM., et al.[2022]

A pilot study using the Nimbus II alternating-pressure mattress for patients after hip replacement surgery showed that none of the patients experienced prosthetic dislocation, indicating safety in its use during recovery.

The study found that 87% of patients did not develop pressure sores, reinforcing the efficacy of alternating-pressure mattresses in preventing pressure injuries in this high-risk group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pressure area management in an orthopaedic setting. Young, T., Haughton, B., Williams, C.[2005]

Prolonged bed-rest is no longer considered essential for treating Deep Venous Thrombosis (DVT), as recent evidence shows that it can actually worsen the condition, while Low Molecular Weight Heparin (LMWH) has proven effective in managing DVT.

Current treatment for DVT emphasizes immediate mobilization, outpatient care, and the use of external compression therapy alongside LMWH and later oral anticoagulants, which helps prevent Pulmonary Embolism (PE) and improves patients' quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Physical treatment of deep venous thrombosis: bed rest or mobilization?]. Manganaro, A., Buda, D., Calabro, D., et al.[2007]

Out of 25,300 medical error reports analyzed from 8 hospitals, 13.3% were linked to adverse events, highlighting significant safety concerns in inpatient care.

The most frequent types of incidents leading to harm included complications from procedures (29%), falls (17%), and medication errors (10%), with skin breakdown and falls posing substantial risks, as they resulted in adverse events in 59% and 22% of cases, respectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Injury and death associated with incidents reported to the patient safety net. Reid, M., Estacio, R., Albert, R.[2009]

In a study of over 108,000 patients who underwent bariatric surgery, major adverse cardiac events (MACE) were rare, occurring in only 0.1% of patients, but were linked to longer hospital stays and higher mortality rates.

Independent predictors of MACE included older age, male sex, and pre-existing cardiopulmonary conditions, while the type of surgery (sleeve gastrectomy vs. Roux-en-Y gastric bypass) did not significantly affect the risk of MACE.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early cardiac complications after bariatric surgery: does the type of procedure matter? Khorgami, Z., Jackson, TN., Aminian, A., et al.[2020]

In a study of 69,490 bariatric surgery patients, the cumulative incidences of adverse events were found to be 12.6 for accidental puncture or laceration, 3.4 for pulmonary embolus or deep venous thrombosis, and 7.3 for postoperative respiratory failure per 1000 discharges.

Risk factors for these adverse events included male gender, older age (especially 50-59 years), a history of chronic lung disease, and Medicare coverage, highlighting the need for targeted evaluations of these high-risk groups to enhance patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

National analysis of adverse patient safety for events in bariatric surgery. Poulose, BK., Griffin, MR., Zhu, Y., et al.[2020]

The 'Buddy Study' program, which includes a seminar and peer support for healthcare professionals after adverse events, received positive feedback from participants, with 91.6% satisfied with the seminar content and 69.1% feeling it helped them manage their emotional responses.

The program fostered a compassionate culture and attentiveness to colleagues' wellbeing, although it highlighted the need for ongoing support and visibility to maintain its effectiveness, suggesting that while valuable, peer support should complement other forms of support rather than replace them.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of'the Buddy Study', a peer support program for second victims in healthcare: a survey in two Danish hospital departments. Schrøder, K., Bovil, T., Jørgensen, JS., et al.[2022]

A survey of 419 healthcare professionals revealed that 93.1% were aware of adverse events, with 44.4% having been directly involved, leading to significant emotional distress, including feelings of guilt and anxiety, among those affected.

The majority of healthcare professionals expressed a strong desire for training on how to handle the aftermath of adverse events and communicate effectively with patients, highlighting the need for support systems for 'second victims' in healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of adverse events and their manifestations in health professionals as second victims Flórez, F., López, L., Bernal, C.[2022]

Massage therapy has been recognized as an effective integrative therapy for managing pain and anxiety in cardiac surgical patients, who often experience discomfort and stress after long surgeries.

The article highlights a clinical case where massage therapy was successfully integrated into a cardiac surgical unit, demonstrating its benefits in reducing pain and tension as part of an evidence-based practice initiative.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Massage therapy: a comfort intervention for cardiac surgery patients. Anderson, PG., Cutshall, SM.[2015]

In a clinical trial involving 12 patients over 14 days, both the ROHO dry-floatation mattress and the Clinitron bed were found to be effective in reducing pressure on myocutaneous flaps after surgery.

Using the less expensive ROHO mattress provided a viable alternative to the high-tech Clinitron bed, potentially lowering healthcare costs while maintaining effective patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the effectiveness of two support surfaces following myocutaneous flap surgery. Economides, NG., Skoutakis, VA., Carter, CA., et al.[2006]

A monitoring system for therapeutic bed usage was implemented at St. Vincent Medical Center to address concerns about prolonged and unnecessary use of these beds, which are designed to prevent pressure injuries.

After one year of monitoring, the results of this system were evaluated, highlighting the importance of appropriate usage of therapeutic beds in a 640-bed tertiary care hospital.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of therapeutic bed monitoring: justification of ET nursing. Kerschbaum, B., Murray, M.[2018]

Citations

1. withpower.com withpower.com/trial/phase-pediatric-cardiology-10-2022-b893e

Weighted Blankets for Recovery from Heart Procedures This trial is testing if using a heavy blanket can help calm patients after heart procedures. The goal is to see if the blanket can reduce their agitation, ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S096522992400092X

Safety and effectiveness of weighted blankets for symptom ... Weighted blankets may be a safe and effective add-on treatment for managing common symptoms such as anxiety, insomnia, depression, and fatigue among ...

3. research.aota.org research.aota.org/ajot/article/74/2/7402205010p1/6662/Weighted-Blanket-Use-A-Systematic-Review

Weighted Blanket Use: A Systematic Review Results of the study showed that both participants achieved a slight increase (1–3 hr) in total sleep per night and a slight decrease in time to ...

4. blogs.the-hospitalist.org blogs.the-hospitalist.org/content/weighted-blankets-may-help-reduce-preoperative-anxiety-during-mohs-micrographic-surgery

Weighted Blankets May Help Reduce Preoperative Anxiety ... Deep pressure tools increase parasympathetic tone, help reduce anxiety, and provide a calming effect.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11993107/

Effect of deep pressure input on autonomic regulation ... Deep pressure input for high-anxiety patients can effectively reduce stress and enhances the parasympathetic activation during the wisdom tooth extraction ...

6. researchgate.net researchgate.net/publication/233228002_Exploring_the_Safety_and_Therapeutic_Effects_of_Deep_Pressure_Stimulation_Using_a_Weighted_Blanket

(PDF) Exploring the Safety and Therapeutic Effects of Deep ... The results reveal that the use of the 30 lb weighted blanket, in the lying down position, is safe as evidenced by the vital sign metrics. Data ...

7. sensisereni.it sensisereni.it/wp-content/uploads/2014/10/Exploring-the-Safety-and-Therapeutic-Effects-of-Deep-Pressure-Stimulation-Using-a-Weighted-Blanket1.pdf

Exploring-the-Safety-and-Therapeutic-Effects-of-Deep- ... The data give no evidence to indicate that the use of the 30 lb weighted blanket is unsafe. Mullen et al. 77. FIGURE 3. Average diastolic and ...