NCT04437095

Positive Suggestions Via MP3 Messages

Delivering Positive Suggestions to the Critically Ill Patients Via Pre-recorded MP3 Messages to Improve Mental Health Outcomes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 149 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Post Intensive Care Unit Syndrome
• Psychological Trauma
• Anxiety
• Depression
• PTSD

Interventions

Type	Name	Description
OTHER	Psychological Support Based on Positive Suggestion delivered via pre-recorded MP3 message	Daily administration of audiorecording

Timeline

• Start date: 2020-08-17
• Primary completion: 2025-02-07
• Completion: 2025-02-07
• First posted: 2020-06-18
• Last updated: 2025-03-28

Locations

1 site across 1 country: United States