Positive Suggestions Via MP3 Messages

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

149 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-17

Study Completion Date

2025-02-07

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Post Intensive Care Unit Syndrome Psychological Trauma Anxiety Depression PTSD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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PSBPS Audiorecording

Thirty minute daily administration of audio recording containing messages of psychological support based on positive suggestion delivered via headphones

Group Type EXPERIMENTAL

Psychological Support Based on Positive Suggestion delivered via pre-recorded MP3 message

Intervention Type OTHER

Daily administration of audiorecording

Control

Standard of care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Psychological Support Based on Positive Suggestion delivered via pre-recorded MP3 message

Daily administration of audiorecording

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No