Positive Audio Suggestions for Critical Illness-Related Stress

Recruiting in Palo Alto (17 mi)

Overseen by Lioudmila Karnatovskaia, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Mayo Clinic

Disqualifiers: Dementia, Psychotic disorders, Hearing impairment, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Psychological Support Based on Positive Suggestion delivered via pre-recorded MP3 message?

Research suggests that psychological support based on positive suggestion can help reduce anxiety and psychological distress in critically ill patients. In one study, patients who received this type of support reported feeling comforted, and there was an indication of lower anxiety compared to historical controls. Additionally, using trained doulas to deliver positive suggestions has been accepted as a viable approach to provide emotional support in intensive care settings. ^{1 2 3 4 5}

Is the use of positive audio suggestions safe for humans?

Research suggests that using positive audio suggestions, such as pre-recorded messages, is generally safe for humans. Studies have shown that these interventions can be comforting and may help reduce psychological distress in critically ill patients without any reported adverse effects. ^{1 2 6 7 8}

How does the treatment of Positive Audio Suggestions for Critical Illness-Related Stress differ from other treatments?

This treatment is unique because it uses pre-recorded positive suggestions delivered via MP3 messages to reduce stress in critically ill patients, which is different from traditional methods like medication or in-person therapy. It focuses on psychological support through audio, aiming to shorten ICU stays and improve recovery by providing comforting and reassuring messages. ^{1 6 9 10 11}

Research Team

Lioudmila Karnatovskaia, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for ICU patients with acute respiratory failure or those needing vasopressors, expected to stay in the ICU for over 48 hours. It's not suitable for individuals with dementia, mental retardation, a history of suicide attempts or psychotic disorders like schizophrenia, alcohol/substance issues, severe metabolic encephalopathy, on comfort care, not expected to survive their hospital stay, hearing impaired or non-English speakers.

Inclusion Criteria

I am experiencing severe breathing problems or need medication to maintain my blood pressure.

I am expected to be in the ICU for more than 48 hours.

I am currently in the Intensive Care Unit.

Exclusion Criteria

I am receiving care focused on my comfort.

Acute alcohol/substance intoxication or withdrawal

History of dementia

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants in the interventional group listen to an audio recording of psychological support based on positive suggestion for about 30 minutes each day via headphones

Duration of ICU stay

Daily sessions

ICU Discharge Assessment

At the time of ICU discharge, patients are administered validated questionnaires to screen for symptoms of anxiety/depression, PTSD, cognitive dysfunction, and health status

Within 96 hours of ICU discharge

Follow-up

Six months post ICU discharge, patients are contacted to repeat the assessment with the same questionnaires

6 months post ICU discharge

Treatment Details

Interventions

• Psychological Support Based on Positive Suggestion delivered via pre-recorded MP3 message (Behavioural Intervention)

Trial Overview The study tests psychological support through positive suggestions delivered via pre-recorded MP3 messages. The goal is to see if these audio recordings can help critically ill patients by providing reliable and feasible psychological support during intensive care.

Participant Groups

Group I: PSBPS Audiorecording Experimental Treatment 1 Intervention

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

Group II: Control Active Control 1 Intervention

Standard of care

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Mayo Clinic in Rochester Rochester, MN

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3427

Patients Recruited

3,221,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a Behavioral Intervention to Reduce Psychological Distress in Mechanically Ventilated Patients. Tan, Y., Gajic, O., Schulte, PJ., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

System of Psychological Support Based on Positive Suggestions to the Critically Ill Using ICU Doulas. Karnatovskaia, LV., Schultz, JM., Niven, AS., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving patient diary use in intensive care: A quality improvement report. Veloso Costa, A., Padfield, O., Elliott, S., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological support and outcomes for ICU patients. Papathanassoglou, ED.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Counselling and support in intensive care. Mellish, VJ.[2015]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shortening the length of stay and mechanical ventilation time by using positive suggestions via MP3 players for ventilated patients. K Szilágyi, A., Diószeghy, C., Fritúz, G., et al.[2021]

The 'POPPI' psychological intervention, designed to reduce acute stress in critical care patients, was found to be feasible and acceptable based on feedback from 127 patients and staff across four UK hospitals.

The intervention included training for staff to provide psychological support and was refined for further evaluation in a larger clinical trial, indicating its potential to prevent future psychological issues in patients after critical care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Providing psychological support to people in intensive care: development and feasibility study of a nurse-led intervention to prevent acute stress and long-term morbidity. Wade, D., Als, N., Bell, V., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Use of positive suggestions in medical practice: experiences in the intensive care unit]. Diószeghy, C., Varga, K., Fejes, K., et al.[2015]

The pilot study enrolled 58 critically ill patients over 3.5 years, demonstrating that ICU diaries are a feasible intervention in a tertiary ICU setting.

Patients who used ICU diaries reported significantly lower anxiety and depression scores 90 days post-ICU compared to those who did not, suggesting that this intervention may effectively reduce psychological distress after critical illness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventing Posttraumatic Stress in ICU Survivors: A Single-Center Pilot Randomized Controlled Trial of ICU Diaries and Psychoeducation. Kredentser, MS., Blouw, M., Marten, N., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stress-reducing effect of physician's tape-recorded support on cardiac surgical patients in the intensive care unit. Hwang, SL., Chang, Y., Ko, WJ., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of psychosomatic medicine in intensive care units. Abrahamian, H., Lebherz-Eichinger, D.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Feasibility of a Behavioral Intervention to Reduce Psychological Distress in Mechanically Ventilated Patients. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

System of Psychological Support Based on Positive Suggestions to the Critically Ill Using ICU Doulas. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Improving patient diary use in intensive care: A quality improvement report. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Psychological support and outcomes for ICU patients. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Counselling and support in intensive care. [2015]

6. Hungary pubmed.ncbi.nlm.nih.gov

Shortening the length of stay and mechanical ventilation time by using positive suggestions via MP3 players for ventilated patients. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Providing psychological support to people in intensive care: development and feasibility study of a nurse-led intervention to prevent acute stress and long-term morbidity. [2021]

8. Hungary pubmed.ncbi.nlm.nih.gov

[Use of positive suggestions in medical practice: experiences in the intensive care unit]. [2015]

9. United States pubmed.ncbi.nlm.nih.gov

Preventing Posttraumatic Stress in ICU Survivors: A Single-Center Pilot Randomized Controlled Trial of ICU Diaries and Psychoeducation. [2019]

10. Singapore pubmed.ncbi.nlm.nih.gov

Stress-reducing effect of physician's tape-recorded support on cardiac surgical patients in the intensive care unit. [2022]

11. Austria pubmed.ncbi.nlm.nih.gov

The role of psychosomatic medicine in intensive care units. [2019]