Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module


Ignite Creation Date: 2025-12-24 @ 7:12 PM
Ignite Modification Date: 2025-12-24 @ 7:12 PM
NCT ID: NCT02305303
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.
Study: NCT02305303
Study Brief:
Protocol Section: NCT02305303