Psychological Trauma and Resilience After Critical Illness
- Conditions
- Acute Respiratory FailureShock
- Registration Number
- NCT05193123
- Lead Sponsor
- Nantes University Hospital
- Brief Summary
Critically ill patients experience a severe physical disease, associated with a psychotrauma, which may lead to post-traumatic stress disorder (17 to 30% of patients after critical illness) and persistent symptoms of anxiety and depression. RESIREA study will study psychodrama, resilience and factors associated with resilience in patients previously included in the NUTRIREA-3 randomized controlled trial designed to compare standard calorie and protein feeding complying with guidelines to low-calorie low-protein feeding in a well-defined group of severely ill ICU patients requiring at least MV and vasoactive drugs.
- Detailed Description
Social demographic data (gender, age, marital status, psychological information and medical background) and medical data (severity of the disease, duration of ICU stay, SOFA score) will be collected, as for the NUTRIREA-3 trial.
Before leaving the ICU, patient who agreed to participate to the NUTRIREA 3 study were asked to participate to the RESIREA study.
Patients will be called by phone by a psychologist 3 months after their inclusion in the NUTRIREA-3 trial to complete the SF-36 score. Then, they will be asked to confirm their participation to the RESIREA study by completing four additional questionnaires (post-trauma stress disorder: IES-R; Resilience: CD-RISC; Social support: MSPSS; Perception of the disease: B-IPQ). If the patient does not respond to the phone call at the first time, he/she will be contacted again within a period of 2 weeks maximum (1 call/day). If the patient remains unreachable, he/she will be considered as lost for the study. Patients will be called again 12 months after their inclusion in the NUTRIREA-3 trial and will be asked to complete the five questionnaires (SF-36, IES-R, CD-RISC, MSPSS and B-IPQ).
During this last phone call, 40 patients will be asked to a third interview by phone. These patients will be spotted thanks to their score at the IES-R and CD-RISC. This interview of 30 to 45 minutes will be planned within 15 days after the T12 call and recorded. This semi structured interview will be lead by an experienced clinical psychologist and follow 4 main topics :
1. Experience of ICU's
2. Perception of the disease or/and post intensive care disorders
3. Difficulties and capacities of coping
4. Difficult events in the patient's life
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- Invasive mechanical ventilation started within the past 24 h, or started before ICU admission with ICU admission within the past 24 h, for an expected duration of at least 48 hours after inclusion
- Treatment with vasoactive agent for shock (adrenaline, dobutamine, or noradrenaline)
- Nutritional support expected to be started within 24 h after intubation
- Age older than 18 years
- Informed consent to participation in the study
- Invasive mechanical ventilation started more than 24 hours earlier
- Specific nutritional needs, such as pre-existing long-term home enteral or parenteral nutrition, or for chronic bowel disease
- Dying patient, not-to-be-resuscitated order, or other treatment limitation decision at ICU admission
- Pregnancy, recent delivery, or lactation
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients with post-traumatic disorders 3 months after ICU stay IES-R scale
- Secondary Outcome Measures
Name Time Method perception of the disease 3 and 12 months after ICU stay MSPSS score
Proportion of resilient patients 3 and 12 months after ICU stay CD-RISC score \> 80
proportion of patients with impaired Quality of life 3 and 12 months after ICU stay SF-36 score
Proportion of patients with post-traumatic disorders 12 months after ICU stay IES-R
Social support 3 and 12 months after ICU stay IES-R
Trial Locations
- Locations (23)
CHU Amiens Picardie nord
🇫🇷Amiens, France
CH Dieppe
🇫🇷Dieppe, France
CH du Mans
🇫🇷Le Mans, France
CHR- Roger Salengro
🇫🇷Lille, France
CH Argenteuil
🇫🇷Argenteuil, France
CHU Jean Minjoz
🇫🇷Besançon, France
CHBA - Vannes Auray
🇫🇷Vannes, France
APHP - Hôpital Raymond Poincaré
🇫🇷Garches, France
CH de Béthune
🇫🇷Béthune, France
CHU Angers
🇫🇷Angers, France
CH Angoulême
🇫🇷Angoulême, France
CH Annecy Genevois
🇫🇷Annecy, France
CHU Amiens Picardie sud
🇫🇷Amiens, France
CHU de Nantes
🇫🇷Nantes, France
CH de Bigorre
🇫🇷Tarbes, France
CH de Lens
🇫🇷Lens, France
CHRU Bretonneau
🇫🇷Tours, France
CHU de Valenciennes
🇫🇷Valenciennes, France
CH Chartres Louis Pasteur
🇫🇷Chartres, France
CHU Gabriel Montpided
🇫🇷Clermont-Ferrand, France
CHD Vendée
🇫🇷La Roche-sur-Yon, France
APHP - Hôpital Cochin
🇫🇷Paris, France
Hôpital Edouard Herriot
🇫🇷Lyon, France