Efficacy of the Use of Diaries in Intensive Care Units

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorUniversity of Barcelona

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

admitted intensive care unit

sedated and mechanically ventilated for 24hours

signed consent

not language barrier

Disqualifiers

verbal manifestation of psychiatric, mental or cognitive antecedents

who do not coluntarily agree to participate

Trial design

Design model

Parallel

Treatments tested in this trial

  • use of diary

    Other intervention

    a diary is made for the experimental group where the events and events during the period of sedation and intubation are explained

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: usual ICU practiceNo intervention 0 interventions
Group B: ICU diaryExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
2 months
2

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.

Time frame
6 months
3

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.

Time frame
12 months
4

SF-36 Health Survey

questionnaries to measure quality of life. 36 items. from 0 to 100, with 100 being the best health

Time frame
2 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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