Efficacy of the Use of Diaries in Intensive Care Units

NCT ID: NCT05288140

Last Updated: 2024-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Diary (Blank Journal) Intensive Care Unit Patient Family PICS Stress Anxiety Depression Quality of Life

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A control group and an experimental group
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

usual ICU practice

The patient's evolution is reported verbally to the family.

Group Type NO_INTERVENTION

No interventions assigned to this group

ICU diary

Made a diary

Group Type EXPERIMENTAL

use of diary

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

use of diary

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* admitted intensive care unit
* sedated and mechanically ventilated for 24hours
* signed consent
* not language barrier
* willingness to attend follow-up visits

Exclusion Criteria

* verbal manifestation of psychiatric, mental or cognitive antecedents
* who do not coluntarily agree to participate
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Barcelona

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Pilar Muñoz Rey

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Universidad de Barcelona

Barcelona, , Spain

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Spain

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Pilar Muñoz Rey

Role: CONTACT

639534904

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

pilar muñoz rey

Role: primary

639534904

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PI-18-138

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

ICU Experience in Family Members
NCT02940028 UNKNOWN NA
Healing Light Algorithms for Nurses in the ICU
NCT05949827 ACTIVE_NOT_RECRUITING