Positive Suggestions Via MP3 Messages
Purpose
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.
Conditions
- Post Intensive Care Unit Syndrome
- Psychological Trauma
- Anxiety
- Depression
- PTSD
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Patients will be randomized 1:1 to intervention vs standard care. Using data from our prior observational study, mean (SD) HADS-Anxiety subscale was 7.3 (4.1) among these subjects (coefficient of variation = 4.1/7.3 = 0.56). A total 300 subjects will be enrolled and randomized until 100 subjects per arm recruitment target is reached to allow for mortality and dropout. The analysis will compare 6 month HADS-A by treatment arms using ANCOVA. The analysis will be conducted under a modified intention to treat principle, with subjects analyzed according to randomized arm, but excluding patients who die before follow up. Additional outcomes including HADS-D, MoCA-blind, and EQ-5D will be analyzed similarly using ANCOVA, and IES-R subscore>1.6 will be analyzed by Chi-square test.
- Primary Purpose
- Prevention
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental PSBPS Audiorecording |
Thirty minute daily administration of audio recording containing messages of psychological support based on positive suggestion delivered via headphones |
|
|
No Intervention Control |
Standard of care |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Mayo Clinic
Detailed Description
Following screening and consenting processes, patients will be randomized to enroll in interventional or control groups. The interventional group will listen to an audio recording of psychological support based on positive suggestion for about 30 min each day via headphones. At the time of ICU discharge, patients will be administered validated questionnaires to screen for symptoms of anxiety/depression (HADS), PTSD (IES-r), cognitive dysfunction (MOCA-blind), as well as evaluation of health status (EQ-5D). Six months post ICU discharge, patients will again be contacted and repeat the assessment with above questionnaires. Scores on the questionnaires will be compared between the groups at the two times points. Patient demographic data will also be obtained and assessed to contextualize study findings.
