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Randomized clinical trial that aims to evaluate the impact of the use of a diary in patients and relatives of patients admitted to an ICU in relation to usual practice in terms of health-related quality of life, the post-traumatic stress and anxiety/depression at 2, 6 and 12 months after ICU discharge.
Randomized, parallel, open, non-blinded, multicenter clinical trial, with an experimental group (diary) and a control group (usual practice), to compare the effect produced on quality of life by post-traumatic stress and anxiety/depression of patients and relatives, whether or not they have access to a diary during the stay in the unit. Three validated scales will be used at three different times. 120 cases per group, carrying out a preliminary pilot test. Data analysis according to IBM SPSS v.24 to describe and compare both groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| usual ICU practice | No Intervention | The patient's evolution is reported verbally to the family. | |
| ICU diary | Experimental | Made a diary |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| use of diary | Other | a diary is made for the experimental group where the events and events during the period of sedation and intubation are explained |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Anxiety and Depression Scale (HADS) | questionnaries, range of 0-21 for either anxiety and depression subscores. Higher scores corresponding to worse outcomes. 0-7 normal; 8-10 borderline abnormal; 11-21 sever symptoms of anxiety or depressin. | 2 months |
| Hospital Anxiety and Depression Scale (HADS) | questionnaries, range of 0-21 for either anxiety and depression subscores. Higher scores corresponding to worse outcomes. 0-7 normal; 8-10 borderline abnormal; 11-21 sever symptoms of anxiety or depressin. | 6 months |
| Hospital Anxiety and Depression Scale (HADS) | questionnaries, range of 0-21 for either anxiety and depression subscores. Higher scores corresponding to worse outcomes. 0-7 normal; 8-10 borderline abnormal; 11-21 sever symptoms of anxiety or depressin. | 12 months |
| SF-36 Health Survey | questionnaries to measure quality of life. 36 items. from 0 to 100, with 100 being the best health | 2 months |
| SF-36 Health Survey | questionnaries to measure quality of life. 36 items. from 0 to 100, with 100 being the best health | 6 months |
| SF-36 Health Survey | questionnaries to measure quality of life. 36 items. from 0 to 100, with 100 being the best health | 12 months |
| Revised Impact of Event Scales (IES-R) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pilar Muñoz Rey | Contact | 639534904 | mpmunozr.germanstrias@gencat.cat |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad de Barcelona | Recruiting | Barcelona | 08185 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41555387 | Derived | Munoz-Rey P, Romero-Garcia M, Angles-Sabate I, Ausio-Dot A, Alonso-Fernandez S, Alcala-Jimenez I, Huertas-Zurriaga A, Tur-Rubio C, Delgado-Hito P. Efficacy of the intensive care unit diary: a mixed-method study protocol. BMC Nurs. 2026 Jan 19;25(1):153. doi: 10.1186/s12912-026-04300-z. |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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A control group and an experimental group
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questionnaries; measuring areas of hyperarousal, avoidance, and intrusion as subscales. Total score ranges from 0-88, higher score associated with worse PTSD symptoms. 1-22 mild PTSD,;22 signal clinically significant PTSD symptoms.
| 2 months |
| Revised Impact of Event Scales (IES-R) | questionnaries; measuring areas of hyperarousal, avoidance, and intrusion as subscales. Total score ranges from 0-88, higher score associated with worse PTSD symptoms. 1-22 mild PTSD,;22 signal clinically significant PTSD symptoms. | 6 months |
| Revised Impact of Event Scales (IES-R) | questionnaries; measuring areas of hyperarousal, avoidance, and intrusion as subscales. Total score ranges from 0-88, higher score associated with worse PTSD symptoms. 1-22 mild PTSD,;22 signal clinically significant PTSD symptoms. | 12 months |