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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a 30-minute audio recording with positive messages can reduce stress for ICU patients. The study compares this approach, known as Psychological Support Based on Positive Suggestion delivered via pre-recorded MP3 message, to standard hospital care. It targets critically ill patients with breathing difficulties or those needing blood pressure support in intensive care. Patients with hearing impairments or who do not speak English are not eligible. As an unphased trial, it offers patients the chance to contribute to innovative approaches in ICU care.

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 prior data suggests that this method is safe for critically ill patients?

Research has shown that audio recordings with positive messages are safe for seriously ill patients. One study found that listening to positive messages through MP3 recordings improved the mental health of people who survived severe breathing problems. This suggests that hearing these messages is well-received and does not cause harm.

Furthermore, a review of several studies found that these audio messages might help patients spend less time on breathing machines and reduce their hospital stay. The research indicates that this type of psychological support is both beneficial and safe for patients.

Overall, evidence supports that listening to positive messages in audio form is a safe way to provide psychological support to seriously ill patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Positive Audio Suggestions for Critical Illness-Related Stress treatment because it offers a novel approach by using psychological support delivered through pre-recorded audio messages. Unlike traditional methods that may involve medication or in-person therapy sessions, this treatment leverages the convenience of a simple MP3 file played through headphones, making it easily accessible and non-invasive. The use of positive suggestion in these audio recordings is designed to help patients manage stress by potentially enhancing their mental well-being in a straightforward and user-friendly manner.

What evidence suggests that positive audio suggestions could be effective for critical illness-related stress?

Research shows that listening to positive audio messages can improve mental health for seriously ill patients. In this trial, participants in the experimental arm will receive psychological support through positive suggestions delivered via pre-recorded MP3 messages. Studies have found that these recordings may reduce anxiety, depression, and stress in patients who have survived severe breathing problems. Specifically, one study found that ICU patients who listened to positive messages experienced emotional improvement. This suggests that hearing encouraging words can effectively support people facing serious illnesses. While more research is needed, early results are promising and demonstrate real benefits. ^{1 2 3 6 7}

Who Is on the Research Team?

Lioudmila Karnatovskaia, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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 currently in the Intensive Care Unit.

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

Exclusion Criteria

I am receiving care focused on my comfort.

Acute alcohol/substance intoxication or withdrawal

History of dementia

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04437095

NCT04437095 | Positive Suggestions Via MP3 Messages 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8078413/

System of Psychological Support Based on Positive ... Results: The ICU doulas performed psychological support based on positive suggestion on 43 critically ill patients in the ICU setting.

3. journal.chestnet.org journal.chestnet.org/article/S0012-3692(23)02209-2/fulltext

POSITIVE SUGGESTIONS DELIVERED AS MP3 ... POSITIVE SUGGESTIONS DELIVERED AS MP3 RECORDINGS MAY IMPROVE MENTAL HEALTH OUTCOMES OF ACUTE RESPIRATORY FAILURE SURVIVORS. MAHMUT OZKAN.

4. researchgate.net researchgate.net/publication/265005989_Effectiveness_of_Psychological_Support_based_on_Positive_Suggestion_with_the_Ventilated_Patient

(PDF) Effectiveness of Psychological Support based on ... In the study they were given psychological support based on positive suggestions (PSBPS) using their susceptibility induced by the situation, ...

5. core.ac.uk core.ac.uk/download/622996864.pdf

System of Psychological Support Based on Positive ... BACKGROUND: Surviving critical illness often creates a lasting psycho- logical impact, including depression, anxiety, and post-traumatic stress.

6. researchgate.net researchgate.net/publication/259530675_Psychological_support_based_on_positive_suggestions_in_the_treatment_of_a_critically_ill_ICU_patient_-_A_case_report

Psychological support based on positive suggestions in the ... This case report describes the way psychological support based on positive suggestions (PSBPS) was added to the traditional somatic ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1036731424002996

A systematic review of the comparative effects of sound ... Shortening the length of stay and mechanical ventilation time by using positive suggestions via MP3 players for ventilated patients. Int Med Appl Sci, 6 (1) ...