Panacea Index Logo

Command Palette

Search for a command to run...

Relaxation for Critically ill Patient Outcomes and

BMJ open
January 1, 1970
Elizabeth D E Papathanassoglou et al. (15 authors)
Clinical Trial ProtocolJournal ArticleResearch Support, Non-U.S. Gov'tHuman StudyClinical
Study Details

Study Goal

The researchers aimed to assess the feasibility and treatment effect estimates of a multimodal integrative intervention (including moderate pressure touch massage) for preventing critical illness delirium and related outcomes in ICU patients.

Results Summary

The study evaluated feasibility outcomes like recruitment rates and protocol adherence, with the primary clinical outcome being delirium incidence (ICDSC ≥4). Secondary outcomes included pain scores, inflammatory biomarkers, and stress levels, but specific results were not detailed in the abstract.

Population

104 ICU patients (ages 18-64 and ≥65) with ICDSC scores of 0-3, recruited from two academic intensive care units.

Effective Dosage

Not specified

Duration

Up to five consecutive days (or until transfer/discharge)

Interactions

None mentioned

Extracted Claims (10)
InterventionDirectionEndpointPopulationDosageImpactClaim #
multimodal integrative intervention incorporating relaxation, guided imagery and moderate pressure touch massage
neutral
prevention of critical illness delirium and related outcomes
patients with Intensive Care Delirium Screening Checklist (ICDSC): 0-3 recruited from two academic intensive care units (ICUs)
-
assess feasibility and treatment effect estimates
#1
multimodal integrative intervention incorporating relaxation, guided imagery and moderate pressure touch massage
neutral
feasibility outcomes
patients with Intensive Care Delirium Screening Checklist (ICDSC): 0-3 recruited from two academic intensive care units (ICUs)
-
will be assessed
#2
multimodal integrative intervention incorporating relaxation, guided imagery and moderate pressure touch massage
neutral
recruitment rates
patients with Intensive Care Delirium Screening Checklist (ICDSC): 0-3 recruited from two academic intensive care units (ICUs)
-
will be assessed
#3
multimodal integrative intervention incorporating relaxation, guided imagery and moderate pressure touch massage
neutral
protocol adherence
patients with Intensive Care Delirium Screening Checklist (ICDSC): 0-3 recruited from two academic intensive care units (ICUs)
-
will be assessed
#4
multimodal integrative intervention incorporating relaxation, guided imagery and moderate pressure touch massage
neutral
incidence of delirium (ICDSC ≥4)
patients with Intensive Care Delirium Screening Checklist (ICDSC): 0-3 recruited from two academic intensive care units (ICUs)
-
will be assessed
#5
multimodal integrative intervention incorporating relaxation, guided imagery and moderate pressure touch massage
neutral
pain scores
patients with Intensive Care Delirium Screening Checklist (ICDSC): 0-3 recruited from two academic intensive care units (ICUs)
-
will be assessed
#6
multimodal integrative intervention incorporating relaxation, guided imagery and moderate pressure touch massage
neutral
inflammatory biomarkers
patients with Intensive Care Delirium Screening Checklist (ICDSC): 0-3 recruited from two academic intensive care units (ICUs)
-
will be assessed
#7
multimodal integrative intervention incorporating relaxation, guided imagery and moderate pressure touch massage
neutral
heart rate variability
patients with Intensive Care Delirium Screening Checklist (ICDSC): 0-3 recruited from two academic intensive care units (ICUs)
-
will be assessed
#8
multimodal integrative intervention incorporating relaxation, guided imagery and moderate pressure touch massage
neutral
stress
patients with Intensive Care Delirium Screening Checklist (ICDSC): 0-3 recruited from two academic intensive care units (ICUs)
-
will be assessed
#9
multimodal integrative intervention incorporating relaxation, guided imagery and moderate pressure touch massage
neutral
quality of life (6 weeks and 4 months) post-ICU discharge
patients with Intensive Care Delirium Screening Checklist (ICDSC): 0-3 recruited from two academic intensive care units (ICUs)
-
will be assessed
#10
Abstract

INTRODUCTION: Delirium is a common complication of critical illness, associated with negative patient outcomes. Preventive or therapeutic interventions are mostly ineffective. Although relaxation-inducing approaches may benefit critically ill patients, no well-designed studies target delirium prevention as a primary outcome. The objective of this study is to assess feasibility and treatment effect estimates of a multimodal integrative intervention incorporating relaxation, guided imagery and moderate pressure touch massage for prevention of critical illness delirium and for related outcomes. METHODS AND ANALYSIS: Randomised, controlled, single-blinded trial with two parallel groups (1:1 allocation: intervention and standard care) and stratified randomisation (age (18-64 years and ≥65 years) and presence of trauma) with blocking, involving 104 patients with Intensive Care Delirium Screening Checklist (ICDSC): 0-3 recruited from two academic intensive care units (ICUs). Intervention group participants receive the intervention in addition to standard care for up to five consecutive days (or until transfer/discharge); control group participants receive standard care and a sham intervention. We will assess predefined feasibility outcomes, that is, recruitment rates and protocol adherence. The primary clinical outcome is incidence of delirium (ICDSC ≥4). Secondary outcomes include pain scores, inflammatory biomarkers, heart rate variability, stress and quality of life (6 weeks and 4 months) post-ICU discharge. Feasibility measures will be analysed descriptively, and outcomes will be analysed longitudinally. Estimates of effects will be calculated. ETHICS AND DISSEMINATION: The study has received approval from the Human Research Ethics Board, University of Alberta. Results will inform the design of a future multicentre trial. TRIAL REGISTRATION NUMBER: NCT02905812; Pre-results.

Medical Subject Headings (MeSH)
AdolescentAdultCritical IllnessDeliriumFemaleHumansMaleMiddle AgedMulticenter Studies as TopicPilot ProjectsQuality of LifeRandomized Controlled Trials as TopicRelaxation TherapySingle-Blind MethodTreatment OutcomeYoung Adult
Study Links
Quality Scores
SafetyNot Assessed
Efficacy65/10
Quality80/10
Citation Metrics
Total Citations1
Citations/Year0.2
Relative Citation Ratio0.08
NIH Percentile3.9%
Research Impact Scores
APT Score0.05
Weight Score1.43
Normalized Score0.62
Related Supplements