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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months following icu discharge
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
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
3,233 Previous Clinical Trials
3,771,761 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the cap on participant numbers for this research trial?

"Correct. Records held on clinicaltrials.gov demonstrate that this medical experiment, which was established on August 17th 2020, is actively seeking participants. 62 individuals must be enrolled at a single centre."

Answered by AI

Is this research actively recruiting participants?

"Affirmative. According to the details posted on clinicaltrials.gov, this experiment is currently recruiting subjects with an initial posting date of August 17th 2020 and last edit on August 10th 2022. For now, 62 people are sought after from a single clinic site."

Answered by AI

Who else is applying?

What state do they live in?
Minnesota
What site did they apply to?
Mayo Clinic in Rochester
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I’ve tried many things including medications and therapies. I’m open and willing to try anything at this point.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Positive Suggestions Via MP3 Messages
Lioudmila Karnatovskaia 2020. "Positive Suggestions Via MP3 Messages". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04437095.
All > Depression > Psychological
~67 spots leftby Jul 2025
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