Clinical Trials Directory

Trials / Completed

CompletedNCT05193123

Psychological Trauma and Resilience After Critical Illness

Psychological Trauma and Resilience After ICU Stay in Patients Treated With Mechanical Ventilation for Severe Critical Illness: the Multicenter, Prospective, Observational RESIREA Study

Status
Completed
Phase
Study type
Observational
Enrollment
200 (actual)
Sponsor
Nantes University Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers

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

Conditions

Timeline

Start date
2018-10-24
Primary completion
2021-03-16
Completion
2021-12-16
First posted
2022-01-14
Last updated
2022-01-14

Locations

23 sites across 1 country: France

Source: ClinicalTrials.gov record NCT05193123. Inclusion in this directory is not an endorsement.