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- Ensaio Clínico NCT07254299
Hipnose para Melhorar o Bem-Estar de Doentes Críticos e Prevenir a Síndrome Pós-Cuidados Intensivos (HypnoPICS)
Hipnose para Melhorar o Bem-estar de Doentes Gravemente Doentes e Prevenir a Síndrome Pós-Cuidados Intensivos
The goal of this clinical trial is to evaluate the effectiveness of a hypnosis intervention in improving well-being at day 28 of an ICU stay. The main question it aims to answer is :
-Does Hypnosis intervention at ICU discharge and on day 7 and 14 on the wards if the patient remains in the hospital, improve wellbeing at 28 days ?
Researchers will compare discharged ICU patients who received standard post-discharge care to discharged ICU patients who received standard post-discharge care and hypnosis intervention on discharge and 7 and 14days after if they are still in the hospital, to see if hypnosis can improve their wellbeing.
Participants will receive a hypnosis session on the day of ICU discharge, a second session seven days post-discharge and a third session at day 14 if they are still in the hospital.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Critically ill patients in the Intensive Care Unit (ICU) face numerous challenges both acutely and in the long term. These patients frequently experience acute pain and anxiety due to intubation and induced comas. Following their ICU discharge, they commonly report decreased well-being and quality of life. Additionally, up to 40% of critically ill patients develop post-intensive care syndrome (PICS), which includes mental, physical, and cognitive sequelae that can persist up to one year after discharge. Heavy sedation and medications necessary to manage pain and anxiety are known risk factors for PICS.
The current standard of care in the ICU includes mobilization and nutrition, pain control, and family engagement and empowerment. Furthermore, no other specific interventions are aimed at improving long-term outcomes and preventing PICS.
Several studies have explored using hypnosis to improve the acute care of ICU patients. For instance, a pain protocol that included hypnosis in burn patients hospitalized in the CHUV (Centre Hospitalier Universitaire Vaudois) resulted in reduced pain intensity, reduced opioid use, reduced anxiety, and better wound outcomes, all while lowering costs. A pilot study involving non-invasive ventilation patients showed that hypnosis could improve comfort, mask tolerance, and anxiety levels. Additionally, studies on relaxation therapy have indicated that electronic relaxation therapy is a promising, safe, and effective non-pharmacological solution to enhance overall comfort in alert and non-delirious ICU patients.
However, despite these efforts, there is a lack of efficient interventions specifically targeting the wellbeing of patients after an ICU stay and the prevention of PICS. Existing interventions, such as follow-up programs, rehabilitation, and psychological follow-up, have shown conflicting results. To date, no studies have specifically assessed the effect of hypnosis on the short and longer-term well-being of critically ill patients leaving the ICU and its possible effect on the prevention of PICS.
The investigators hypothesize that providing a hypnosis session at ICU discharge and followed by subsequent sessions on days 7 and 14 on the ward will improve well-being in the short term and reduce PICS symptoms at 3-months. The primary outcome will be the assessment of well-being at day 28 post-ICU discharge. Secondary outcomes will be anxiety, depression, PTSD, and quality of life at three months.
Hypothesis and primary objective The investigators hypothesize that providing intervention with hypnosis at ICU discharge and subsequent sessions on day 7 and 14 on the ward if the patient remains in the hospital will improve wellbeing at day 28 and reduce PICS symptoms at three months in critically ill patients.
Primary Objective:
The primary objective of this study is to evaluate the effectiveness of a hypnosis intervention in improving well-being at day 28 of an ICU stay.
Scale used for wellbeing:
- ESAS, total 90, each item on a 0-10 scale
- EQ-5D-5L
Secondary Objectives:
-
To assess the impact of a hypnosis intervention to improve PICS at 3 months
- Anxiety and depression: PHQ-9 et GAD-7
- Post-traumatic stress disorder: PDI and IES-R scale
- Quality of life: SF-12, EQ-5D-5L and WHODAS 2.0
- Patient impression of change: PGIC
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To evaluate patient immediate wellbeing after the hypnosis intervention. • ESAS before after the session in patients who will get the session
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Hannah Wozniak, Medical Doctor
- Número de telefone: +41
- E-mail: hannah-wozniak@hug.ch
Estude backup de contato
- Nome: Jennifer B. C. S Muradbegovic, Doctor
- Número de telefone: +41 79 55 36255
- E-mail: jennifer.cau@hug.ch
Locais de estudo
-
-
-
Geneva, Suíça, 1205
- Recrutamento
- University Hospital of Geneva
-
Contato:
- Hannah Wozniak, Medical Doctor
- Número de telefone: +41
- E-mail: hannah-wozniak@hug.ch
-
Contato:
- Jennifer Muradbegovic, Doctor
- Número de telefone: +41 79 55 36255
- E-mail: jennifer.cau@hug.ch
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Neuchâtel, Suíça
- Ainda não está recrutando
- Hôpitaux Neuchâtelois
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Contato:
- Marie-Eve Brunner, Medical Doctor
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- On Mechanical Ventilation for at least 2 days
- Able to give informed consent as documented by signature
- French speaking
Exclusion Criteria:
- Refusal of the patient
- Patient transferred from another ICU
- Patient is planned for a withdrawal of care or is actively dying
- Glasgow coma scale (GCS) <15 on ICU discharge
- Patient presenting with delirium (detected by CAM-ICU) on ICU discharge
- Patient hospitalized for traumatic brain injury
- Patient is in jail
- Patient hospitalized for more than 28 days in the ICU
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Hypnosis group
Participants in the intervention group will receive a hypnosis session on the day of discharge, a second session seven days post-discharge, and a third session on day 14 if they are still in the hospital. Trained professionals will conduct the hypnosis sessions following a standardized protocol, designed by the study team for critically ill patients. |
the hypnosis will be tailored to each patient. Key elements will include relaxation (to mitigate anxiety and stress and help the patient feel more comfortable, secure, and competent), reassociation techniques (to help the patient reconnect with their body, promoting a sense of embodiment and presence), and safe place (to introduce a safe and calming place to instill a sense of control and competence, aiding in emotional stabilization and fostering a sense of safety and well-being). |
|
Sem intervenção: Control group
Participants in the control group will receive standard post-discharge care, which includes mobilization, nutrition, pain control, and family engagement and empowerment, without any hypnosis intervention. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Wellbeing at day 28 post intensive care unit discharge
Prazo: Day 28 post intensive care unit discharge
|
ESAS scale (Edmonton Symptom Assessment System) with a range from 0 to 100. Higher scores means worse wellbeing. |
Day 28 post intensive care unit discharge
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Immediate wellbeing following a hypnosis session
Prazo: Day 1 (Day of discharge from ICU), day 7, day 14
|
1) ESAS scale before and after the hypnosis session performed on Day 1 (ICU discharge), Day 7 and D14 -The ESAS scale (Edmonton Symptom Assessment System) has a range from 0 to 100. |
Day 1 (Day of discharge from ICU), day 7, day 14
|
|
PDI - Peritraumatic distress inventory
Prazo: day 28 post ICU discharge
|
PDI (Peritraumatic distress index, range: 13-65) |
day 28 post ICU discharge
|
|
PHQ-9 - Patient Health Questionnaire-9
Prazo: Day 28 post intensive care unit discharge and 3 months post intensive care
|
PHQ-9 (Patient Health Questionnaire-9: range 0-27) will be used to assess depressive symptoms at day 28 and 3 months |
Day 28 post intensive care unit discharge and 3 months post intensive care
|
|
GAD-7 - Generalized Anxiety Disorder-7
Prazo: at day 28 and 3 months post ICU discharge
|
GAD-7 (Generalized Anxiety Disorder-7, range 0-21) will be used to assess anxiety symptoms at day 28 and 3 months post ICU discharge |
at day 28 and 3 months post ICU discharge
|
|
IES-R (Impact of event Scale)
Prazo: 3 months post intensive care unit discharge. Higher score means more PTSD symptoms.
|
Range: 0-88 |
3 months post intensive care unit discharge. Higher score means more PTSD symptoms.
|
|
EQ-5D-5L (Quality of life)
Prazo: Day 28 post intensive care unit discharge and 3 months post intensive care unit discharge
|
Part 1) 5 dimensions: Mobility, Self-care, Usual activities, Pain/discomfort, Anxiety/depression. The 5-digit health state is converted (via country-specific value set) to an index value Part 2) EQ VAS (Visual Analog Scale). Patient rates their health today from 0 to 100. Higher scores mean better quality of life. |
Day 28 post intensive care unit discharge and 3 months post intensive care unit discharge
|
|
PGIC - Patient Global Impression of Change
Prazo: Day 28 post intensive care unit discharge and 3 months post intensive care unit discharge
|
Single-item global rating of how much the patient feels their condition has changed since a reference time. Higher scores means improvement. Scoring / range: 1-7 |
Day 28 post intensive care unit discharge and 3 months post intensive care unit discharge
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Hannah Wozniak, Medical Doctor, University Hospital, Geneva
- Investigador principal: Matteo Coen, MD, PHD, University Hospital, Geneva
Publicações e links úteis
Publicações Gerais
- Schmidt B, Schneider J, Deffner T, Rosendahl J. Hypnotic suggestions of safety improve well-being in non-invasively ventilated patients in the intensive care unit. Intensive Care Med. 2021 Apr;47(4):485-486. doi: 10.1007/s00134-021-06364-8. Epub 2021 Feb 16. No abstract available.
- Spiegel D, Cardena E. New uses of hypnosis in the treatment of posttraumatic stress disorder. J Clin Psychiatry. 1990 Oct;51 Suppl:39-43; discussion 44-6.
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2025-00369
- 2025 (Concessão/Contrato do NIH dos EUA)
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