Diary (Blank Journal)QUADERNNCT05288140
Efficacy of the Use of Diaries in Intensive Care Units
A study testing use of diary in people with Diary (Blank Journal) and Intensive Care Unit, run by University of Barcelona at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Diary (Blank Journal), Intensive Care Unit, Patient
- What is being tested?
- use of diary
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- admitted intensive care unit
- sedated and mechanically ventilated for 24hours
- signed consent
- not language barrier
- willingness to attend follow-up visits
Who cannot join
- verbal manifestation of psychiatric, mental or cognitive antecedents
- who do not coluntarily agree to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Universidad de Barcelona
Barcelona, 08185
pilar muñoz rey, 639534904, mpmunozr.germanstrias@gencat.cat
About this study
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.
Read the detailed description
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.
- Conditions
- Diary (Blank Journal), Intensive Care Unit, Patient, Family, PICS, Stress
- Being tested
- use of diary
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
use of diaryOther
a diary is made for the experimental group where the events and events during the period of sedation and intubation are explained
| Study group | Role | What they receive |
|---|---|---|
| usual ICU practice | No intervention | The patient's evolution is reported verbally to the family. |
| ICU diary | Experimental | Made a diary Receives: Other: use of diary |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 12 months
SF-36 Health Survey
questionnaries to measure quality of life. 36 items. from 0 to 100, with 100 being the best health
Measured: 2 months
SF-36 Health Survey
questionnaries to measure quality of life. 36 items. from 0 to 100, with 100 being the best health
Measured: 6 months
SF-36 Health Survey
questionnaries to measure quality of life. 36 items. from 0 to 100, with 100 being the best health
Measured: 12 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start1 Jan 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diary (Blank Journal)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A control group and an experimental group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pilar Muñoz Rey, University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05288140
- Sponsor's protocol ID
- PI-18-138
- Acronym
- QUADERN
- Status last verified
- Mar 2024
- First submitted
- 1 Feb 2022
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41555387
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Use of Diaries in Intensive Care Units
- ClinicalTrials.gov ID
- NCT05288140
- Acronym / sponsor ID
- QUADERN / PI-18-138
- Conditions
- Diary (Blank Journal), Intensive Care Unit, Patient, Family, PICS, Stress
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University of BarcelonaUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- A control group and an experimental group
| Arm | Type | Receives |
|---|---|---|
| usual ICU practice | No intervention | –The patient's evolution is reported verbally to the family. |
| ICU diary | Experimental | Other: use of diaryMade a diary |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- admitted intensive care unit
- sedated and mechanically ventilated for 24hours
- signed consent
- not language barrier
- willingness to attend follow-up visits
Key exclusion criteria (2 listed)
- verbal manifestation of psychiatric, mental or cognitive antecedents
- who do not coluntarily agree to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| use of diarya diary is made for the experimental group where the events and events during the period of sedation and intubation are explained | Other | ICU diary |
Primary outcome
Hospital Anxiety and Depression Scale (HADS)
Time frame: 2 months
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.
Hospital Anxiety and Depression Scale (HADS)
Time frame: 6 months
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.
Hospital Anxiety and Depression Scale (HADS)
Time frame: 12 months
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.
SF-36 Health Survey
Time frame: 2 months
questionnaries to measure quality of life. 36 items. from 0 to 100, with 100 being the best health
SF-36 Health Survey
Time frame: 6 months
questionnaries to measure quality of life. 36 items. from 0 to 100, with 100 being the best health
SF-36 Health Survey
Time frame: 12 months
questionnaries to measure quality of life. 36 items. from 0 to 100, with 100 being the best health
Revised Impact of Event Scales (IES-R)
Time frame: 2 months
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.
Revised Impact of Event Scales (IES-R)
Time frame: 6 months
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.
Revised Impact of Event Scales (IES-R)
Time frame: 12 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
- Derived from this study: PubMed 41555387Munoz-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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing use of diary in people with Diary (Blank Journal) and Intensive Care Unit, run by University of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pilar Muñoz Rey (639534904, mpmunozr.germanstrias@gencat.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Anxiety and Depression Scale (HADS) (time frame: 2 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05288140, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2024.