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Positive Audio Suggestions for Critical Illness-Related Stress

N/A
Recruiting
Led By Lioudmila Karnatovskaia, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Acute respiratory failure and/or requiring vasopressors
Expected to stay >48 hours in the ICU
Must not have
Patients on comfort care
Severe metabolic encephalopathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months following icu discharge
Awards & highlights

Summary

This trial will test whether playing an audio recording with positive suggestions can help improve the mental state of critically ill patients.

Who is the study for?
This trial is for ICU patients with acute respiratory failure or those needing vasopressors, expected to stay in the ICU for over 48 hours. It's not suitable for individuals with dementia, mental retardation, a history of suicide attempts or psychotic disorders like schizophrenia, alcohol/substance issues, severe metabolic encephalopathy, on comfort care, not expected to survive their hospital stay, hearing impaired or non-English speakers.
What is being tested?
The study tests psychological support through positive suggestions delivered via pre-recorded MP3 messages. The goal is to see if these audio recordings can help critically ill patients by providing reliable and feasible psychological support during intensive care.
What are the potential side effects?
Since this intervention involves listening to positive suggestion messages and does not include medication or invasive procedures, no direct physical side effects are anticipated. However emotional responses may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am experiencing severe breathing problems or need medication to maintain my blood pressure.
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I am expected to be in the ICU for more than 48 hours.
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I am currently in the Intensive Care Unit.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am receiving care focused on my comfort.
Select...
I have a severe brain disorder due to a metabolic problem.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months following icu discharge
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months following icu discharge for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
EQ-5D
Anxiety
Hospital Anxiety and Depression Scale (HADS) - Depression
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: PSBPS AudiorecordingExperimental Treatment1 Intervention
Thirty minute daily administration of audio recording containing messages of psychological support based on positive suggestion delivered via headphones
Group II: ControlActive Control1 Intervention
Standard of care

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,298 Previous Clinical Trials
3,958,145 Total Patients Enrolled
Lioudmila Karnatovskaia, MDPrincipal Investigator - Mayo Clinic
Mayo Clinic Hospital-Rochester Saint Marys Campus
University Of Florida College Of Medicine (Medical School)
2 Previous Clinical Trials
94 Total Patients Enrolled

Media Library

Psychological Trauma Research Study Groups: Control, PSBPS Audiorecording
Psychological Trauma Patient Testimony for trial: Trial Name: NCT04437095 — N/A
~47 spots leftby Jul 2025
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