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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
Study Summary
This trial will study the effects of weighted blankets on patients recovering from heart procedures, with the goal of reducing agitation and the need for sedation.
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.Check my eligibility
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.See study design
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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Average Richmond Agitation Sedation Scale (RASS) compared between the two groups
Secondary outcome measures
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 moreTrial 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
Find a Location
Who is running the clinical trial?
University of MichiganLead Sponsor
1,797 Previous Clinical Trials
6,377,938 Total Patients Enrolled
Brian Armstrong, RNPrincipal InvestigatorUniversity of Michigan
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I weigh less than 40 pounds.I weigh more than 220 pounds.I need heart and lung checks right after surgery.I have not had open heart surgery in the last 30 days.I have severe asthma.I have a tracheostomy.I am currently using a cast, brace, or splint due to fractures.I have severe high blood pressure in the lungs.I will be on bed rest for more than 2 hours after my procedure.I have seizures that are not controlled by medication.I have been diagnosed with PTSD.I have a lung condition that restricts my breathing, like scoliosis.I have areas of damaged skin.I am undergoing a heart procedure involving catheters.I have a feeding tube placed through my abdomen.I have a condition like cerebral palsy that affects my muscles.I have been diagnosed with diaphragm weakness.
Research Study Groups:
This trial has the following groups:- Group 1: Weighted blanket
- Group 2: Standard of Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What criteria must a person fulfill in order to be accepted into this research project?
"This trial is recruiting 120 kids between 3 and 17 years old that require cardiac catheterization. To be eligible, participants must have a post-procedure repose plan of more than 2 hours in the Cardiac PACU on the 11th floor."
Answered by AI
Is the eligibility criteria for this medical study inclusive of individuals above twenty years old?
"As stated in the criteria for inclusion, the age boundaries for this medical trial are 3 years old and 17 years old."
Answered by AI
How many individuals are engaging in this research initiative?
"Accurate. Information posted on clinicaltrials.gov reveals that this research is actively signing up volunteers for its trial, which was initially published on November 1st 2022 and most recently updated a few weeks later at the end of the same month. This investigation aims to recruit 120 individuals from one centre alone."
Answered by AI
Are there any vacancies available for participants in this trial?
"Correct. According to the clinicaltrials.gov, recruitment for this medical experiment is currently in progress. This trial was first published on November 1st 2022 and last updated on November 21st of that same year. The study requires 120 participants from a single site."
Answered by AI
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