Trial reportTrials2016
Reduction of self-perceived discomforts in critically ill patients in French intensive care units: study protocol for a cluster-randomized controlled trial.
Trial report in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02442934 (A Multicomponent Intervention to Reduce Perceived Discomforts in Critically Ill Patients), which is not on this map. Cited by 12 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Multicomponent Intervention to Reduce Perceived Discomforts in Critically Ill Patients: a Randomized Controlled Trial
Who cites it
12 citing papers in PubMed, 22 citations in OpenAlex.
- A tailored multicomponent program to reduce discomfort in critically ill patients: a cluster-randomized controlled trial.Intensive care medicine · 2017Trial
- An overview of optimal designs under a given budget in cluster randomized trials with a binary outcome.Statistical methods in medical research · 2023Review
- Corporeal rehabilitation to manage acute stress in critically ill patients.Annals of intensive care · 2022Article
- Risk factors and events in the adult intensive care unit associated with pain as self-reported at the end of the intensive care unit stay.Critical care (London, England) · 2020Article
- Sample size calculation in three-level cluster randomized trials using generalized estimating equation models.Statistics in medicine · 2020Article
- The 4 U's Rule of Fibromyalgia: A Proposed Model for Fatigue in a Sample of Women with Fibromyalgia: A Qualitative Study.International journal of environmental research and public health · 2020Article
- Optimal designs in three-level cluster randomized trials with a binary outcome.Statistics in medicine · 2019Article
- Assessment of patients' self-perceived intensive care unit discomforts: Validation of the 18-item version of the IPREA.Health and quality of life outcomes · 2019Article
- Tailored multicomponent program for discomfort reduction in critically ill patients may decrease post-traumatic stress disorder in general ICU survivors at 1 year.Intensive care medicine · 2019Observational
- Relative efficiency of unequal versus equal cluster sizes in cluster randomized trials using generalized estimating equation models.Biometrical journal. Biometrische Zeitschrift · 2018Article
- Optimal design of longitudinal data analysis using generalized estimating equation models.Biometrical journal. Biometrische Zeitschrift · 2017Article
- Nurses' Attitudes, Practices, and Barriers to Assessing Symptoms of Discomfort in Mechanically Ventilated Patients: A Cross-Sectional Study.SAGE open nursingArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 10 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIt is now well documented that critically ill patients are exposed to stressful conditions and experience discomforts from multiple sources. Improved identification of the discomforts of patients in intensive care units (ICUs) may have implications for managing their care, including consideration of ethical issues, and may assist clinicians in choosing the most appropriate interventions. The primary objective of this study was to assess the effectiveness of a multicomponent program of discomfort reduction in critically ill patients. The secondary objectives were to assess the sustainability of the impact of the program and the potential seasonality effect. METHODS/
designWe conducted a multicenter, cluster-randomized, controlled, single (patient)-blind study involving 34 French adult ICUs. The experimental intervention was a 6-month period during which the multicomponent program was implemented in the ICU and included the following steps: identification of discomforts, immediate feedback to the healthcare team, and implementation of targeted interventions. The control intervention was a 6-month period during which any program was implemented. The primary endpoint was the monthly overall score of self-reported discomfort from the French questionnaire on discomforts in ICU patients (IPREA). The secondary endpoints were the scores of the discomfort items of IPREA. The sample size was 660 individuals to obtain 80% power to detect a 25% difference in the overall discomfort score of IPREA between the two groups (design effect: 2.9). DISCUSSION: The results of this cluster-randomized controlled study are expected to confirm that a multicomponent program of discomfort reduction may be a new strategy in the management of care for critically ill patients.
trial registrationClinicalTrials.gov NCT02442934, registered 11 May 2015.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.