Diary for Severe Trauma

NCT ID: NCT02305303

Last Updated: 2021-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 226 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-09
• Study Completion Date: 2017-11-08

Brief Summary

Treatment of severe trauma patients includes intensive cares. Both trauma and intensive care may lead to a post-traumatic stress disorder‬ and then to a decreased quality of life. Diaries may improve the frequency and the intensity of PTSD. Aim of investigator is to assess if diaries may improve quality of life after a severe trauma.

Detailed Description

Trauma is the third cause of death in France and the first cause of death of people under 40 years (48 000 deaths a year).

Severe trauma defined by an Injury Severity Score ( ISS) > 15 implies intensive care.

Intensive care unit admission induces considerable psychological distress and memory troubles, both promoting posttraumatic stress disorder (PTSD) and symptoms of anxiety and depression. A diary written prospectively during the ICU stay by the staff and relatives has been suggested as a means of help¬ing patients to build a more detailed and factual narrative of their ICU stay than would be possible based only on their fragmented memories. Garrouste et al. have shown that the intensive care unit diary significantly affected posttraumatic stress disorders in surviving patients 12 months after intensive care unit discharge.

Besides, severe trauma by itself may decrease the quality of life (QoL). It is recommended to assess QoL on one year after the trauma. In trauma patients, the change in QoL is associated with the presence of a PTSD.

Consequently, severe trauma patients who undergo a double stress, that of the accident and that of the intensive care unit stay: they may so even more have a decrease of their QoL by developing a PSTD.

The investigator formulate the hypothesis that a diary, written by the staff and relatives from the very acute phase of the ICU stay (first 48 hours) to the discharge of ICU would improve the QoL and would decrease the frequency and the intensity of PTSD of the severe trauma patients one year after the trauma.

Conditions

Post-traumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Diary

Use of diary

Group Type: EXPERIMENTAL

Diary

Intervention Type: PROCEDURE

A diary written prospectively during the ICU stay by the staff and relatives

Without Diary

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Diary

A diary written prospectively during the ICU stay by the staff and relatives

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• all patients over 18
• with severe trauma (Injury Severity Score (ISS) > 15)
• admitted in our trauma centered and hospitalized in intensive care unit for more than 48 h

Exclusion Criteria

• non-French language fluent patients
• Patients with dementia
• Hospitalization in intensive care unit less than
• opposition to data utilization

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marie Benazzour, Nurse

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Département d'Anesthésie-Réanimation Groupe Hospitalier Pitié Salpêtrière

Paris, , France

Countries

France

Other Identifiers

K131202

Identifier Type: -

Identifier Source: org_study_id