Positive Suggestions Via MP3 Messages
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Anxiety
- Depression
- Post Intensive Care Unit Syndrome
- Psychological Trauma
- PTSD
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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 sample size of 25 per arm provides 90% power to detect a 40% decrease in mean HADS-A, assuming a two-sided t-test with unequal variances at alpha level 0.05 and conservatively assuming a coefficient of variation of 0.6. A total 62 subjects will be enrolled and randomized to allow for 20% 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.Masking: None (Open Label)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 disch...
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.
Tracking Information
- NCT #
- NCT04437095
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Lioudmila Karnatovskaia, MD Mayo Clinic
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