What is the mechanism of action of this treatment?

Common treatments for cardiac catheterization include sedation and analgesia to manage pain and anxiety, as well as anticoagulants to prevent thrombosis. Sedation and analgesia work by depressing the central nervous system to reduce anxiety and pain, which is crucial for patient comfort and cooperation during the procedure. Anticoagulants prevent blood clot formation, reducing the risk of complications such as stroke or myocardial infarction. The use of weighted blankets, which provide deep pressure stimulation, can reduce agitation and anxiety, potentially decreasing the need for additional sedation and improving overall patient outcomes.

What side effects are associated with this type of intervention?

Common treatments associated with cardiac catheterization include the use of sedatives and analgesics to manage pain and anxiety. Known side effects of these treatments can include respiratory depression, hypotension, nausea, vomiting, and prolonged sedation. In the context of the study on weighted blankets, which aims to reduce post-procedural agitation, the use of weighted blankets may help minimize the need for additional sedatives, potentially reducing these side effects and improving patient comfort and safety.

What prior FDA approvals exist?

FDA-approved treatments for managing agitation post-cardiac catheterization typically include sedatives and anxiolytics such as benzodiazepines (e.g., midazolam) and antipsychotics (e.g., haloperidol). These medications help to calm patients and reduce anxiety or agitation following the procedure. While the use of weighted blankets for reducing agitation through deep pressure stimulation is being studied, it is not yet an FDA-approved treatment. The focus remains on pharmacologic interventions to manage post-procedural agitation effectively.

What other types of research exist?

Promising novel alternatives to weighted blankets for reducing agitation in cardiac catheterization patients include: 1) Hypnotherapy, which has been shown to reduce procedure-related pain and distress in cancer patients. 2) Mindfulness-Based Stress Reduction (MBSR), which has demonstrated effectiveness in improving mood and quality of life in cancer patients. 3) Acupuncture, which has been effective in managing pain and anxiety in various medical conditions. These alternatives offer non-pharmacologic approaches that can help manage agitation through relaxation and stress reduction techniques.

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Weighted Blankets for Recovery from Heart Procedures

N/A

Recruiting

Led By Brian Armstrong, RN

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 60 minutes (after arrived to pacu)

Awards & highlights

No Placebo-Only Group

Summary

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, so they need less extra medicine and have fewer complications.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort due to weight of the blanket leading possibly to increased anxiety or difficulty breathing especially in patients with underlying respiratory issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 60 minutes (after arrived to pacu)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 60 minutes (after arrived to pacu)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 minutes (after arrived to pacu) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Average Richmond Agitation Sedation Scale (RASS) compared between the two groups

Secondary study objectives

Analgesia administered in the recovery area

Incidence of vascular complications in the recovery area

Safety measures assessed by vital sign parameters for absolute oxygen (O2 saturation)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Weighted blanketExperimental Treatment1 Intervention

Group II: Standard of CareActive Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Weighted blanket

2018

N/A

~30

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for cardiac catheterization include sedation and analgesia to manage pain and anxiety, as well as anticoagulants to prevent thrombosis. Sedation and analgesia work by depressing the central nervous system to reduce anxiety and pain, which is crucial for patient comfort and cooperation during the procedure. Anticoagulants prevent blood clot formation, reducing the risk of complications such as stroke or myocardial infarction. The use of weighted blankets, which provide deep pressure stimulation, can reduce agitation and anxiety, potentially decreasing the need for additional sedation and improving overall patient outcomes.

A Standardized and Comprehensive Approach to the Management of Cardiogenic Shock.Management of cardiogenic shock.Transcatheter Intervention of Coronary Obstructions in Infants, Children, and Young Adults.