Positive Suggestions Via MP3 Messages

Mayo Clinic

Status: Completed

Conditions: PTSD; Post Intensive Care Unit Syndrome; Depression; Anxiety; Psychological Trauma

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04437095

20-003735

Details and patient eligibility

About

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.

Full 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.

Enrollment: 149 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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149 participants in 2 patient groups

PSBPS Audiorecording

Experimental group

Description:

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

Treatment:

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

Control

No Intervention group

Description:

Standard of care