Positive Suggestions Via MP3 Messages (NCT04437095) | Clinical Trial Compass
CompletedNot Applicable
Positive Suggestions Via MP3 Messages
United States149 participantsStarted 2020-08-17
Plain-language summary
The purpose of this study is to assess the use of an audio recording containing positive suggestion as a means to provide needed psychological support to critically ill patients in a feasible and reliable manner.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Acute respiratory failure and/or requiring vasopressors
* Admitted to the ICU
* Expected to stay \>48 hours in the ICU
Exclusion Criteria:
* History of dementia
* History of mental retardation
* History of suicide attempt
* History of psychotic disorders such as schizophrenia
* Acute alcohol/substance intoxication or withdrawal
* Severe metabolic encephalopathy
* Patients on comfort care
* Patients not expected to survive the hospital stay
* Those with hearing impairment
* Non-English speaking.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used MP3 audio messages with positive suggestions for people recovering from an ICU stay — since it's already completed, has my doctor seen any of the results, and do they think that kind of approach could help with my anxiety or depression after my own ICU experience?
2The trial focused on something called Post Intensive Care Unit Syndrome, which can include anxiety, depression, and PTSD — does my doctor think I might be experiencing this, and what screening or follow-up care is typically recommended after an ICU stay?
3Since this study measured anxiety using the Hospital Anxiety and Depression Scale and is now completed, would my doctor consider using that same tool to assess where I currently stand, and would the findings from this trial change how they'd approach my care?
4Before considering any experimental approach like this, are there established treatments for post-ICU anxiety or PTSD — like therapy or medication — that my doctor thinks I should try first?
5Given that this trial is listed as Phase NA, meaning it was likely exploratory or investigational rather than a large confirmatory study, how much confidence would my doctor have in its findings, and does it change their recommendation for my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Hospital Anxiety and Depression Scale (HADS) - Anxiety