Positive Audio Suggestions for Critical Illness-Related Stress

Overseen By Kimberly R Johnson, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Dementia, Psychotic disorders, Hearing impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Duration of ICU stay

149 Participants Needed

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

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

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

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Findings from Research

A small study involving 20 intubated patients showed that delivering psychological support based on positive suggestion by intensivists may help reduce psychological distress after acute respiratory failure, with 38% of patients meeting criteria for anxiety, depression, or acute stress.

Of the 13 patients who completed follow-up surveys, many found the intervention comforting, suggesting that PSBPS could be a valuable addition to medical treatment in critical care, warranting further research in a larger randomized study.

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]

A program was successfully implemented to train doulas to provide psychological support based on positive suggestion to 43 critically ill patients in the ICU, showing that this approach can be beneficial even in altered cognitive states.

Feedback from patients, families, and ICU nurses was overwhelmingly positive, with 37 out of 40 patients recalling the intervention as comforting, indicating that doulas can effectively enhance emotional support in critical care settings.

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]

A quality improvement project successfully increased diary provision for patients in the intensive care unit from 26.1% to 100%, demonstrating the effectiveness of simple changes in practice.

Implementing alerts, educational sessions, and guidance documents significantly enhanced multidisciplinary team engagement with patient diaries, which can improve psychological outcomes for critically ill patients.

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]

Psychological support during ICU treatment, including techniques like relaxation and guided imagery, significantly improves patients' psychological and physiological outcomes, such as vital signs, pain levels, anxiety, and overall satisfaction.

The review of 14 studies indicates that systematic psychological support from nurses can lead to shorter hospital stays and better recovery, highlighting the need for ICU nurses to prioritize these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Counselling and support provided by nurses can significantly enhance psychological care for patients and their families during critical illness, helping them cope with emotional distress.

The paper discusses the development of a counselling service, emphasizing the importance of selecting appropriate theories and processes in delivering effective support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Patients in the ICU who received standardized positive suggestive messages via MP3 player had significantly shorter ICU stays (134.2 hours) and less time on ventilation (85.2 hours) compared to the control group (314.2 hours and 232.0 hours, respectively).

The study demonstrated that positive suggestive communication can effectively enhance recovery in critically ill patients, even when they have higher severity scores (SAPS II) than the control group.

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]

Patients in stressful states, such as illness or pain, are more susceptible to both direct and implicit suggestions, which can significantly influence their psychological state and recovery process.

Effective communication in intensive care settings should focus on delivering positive suggestions while being mindful of the implicit meanings of words and actions to avoid unintended negative impacts on patient well-being.

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]

A tape-recorded message from the attending surgeon significantly reduced pain, tension, anxiety, and depression in 60 heart surgery patients in the ICU, demonstrating its efficacy as a stress-reducing intervention.

Patients who received the recorded support showed a greater increase in finger skin temperature, indicating a physiological response to the emotional support, and expressed a high need for such programs, with an average need score of 8.4.

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]

Critically ill patients, their relatives, and intensive care staff experience significant stress due to life-threatening conditions and the intensive care environment, leading to mental health issues like anxiety and posttraumatic stress disorders.

Integrating psychosomatic medicine into intensive care can help identify and address these stressors early, and implementing stress-reducing measures, such as music therapy and sensory aids, can improve overall wellbeing and potentially enhance recovery outcomes.

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]