Effects of an Integrative Nursing Intervention on Pain in Critically Ill Patients: A Pilot Clinical Trial

Abstract

Background Pain, a persistent problem in critically ill patients, adversely affects outcomes. Despite recommendations, no evidence-based nonpharmacological approaches for pain treatment in critically ill patients have been developed. Objectives To investigate the effects of a multimodal integrative intervention on the incidence of pain and on secondary outcomes: intensity of pain, hemodynamic indices (systolic and mean arterial pressure, heart rate), anxiety, fear, relaxation, optimism, and sleep quality. Methods A randomized, controlled, double-blinded repeated-measures trial with predetermined eligibility criteria was conducted. The intervention included relaxation, guided imagery, moderate pressure massage, and listening to music. The primary outcome was incidence of pain (score on Critical Care Pain Observation Tool > 2). Other outcomes included pain ratings, hemodynamic measurements, self-reported psychological outcomes, and quality of sleep. Repeated-measures models with adjustments (baseline levels, confounders) were used. Results Among the 60 randomized critically ill adults in the sample, the intervention group experienced significant decreases in the incidence (P = .003) and ratings of pain (P < .001). Adjusted models revealed a significant trend for lower incidence (P = .002) and ratings (P < .001) of pain, systolic arterial pressure (P < .001), anxiety (P = .01), and improved quality of sleep (P = .02). Conclusion A multimodal integrative intervention may be effective in decreasing pain and improving painrelated outcomes in critically ill patients. (American Journal of Critical Care. 2018; 27:172-185) EFFECTS OF Unrelieved pain is common among ICU patients and may compromise outcomes, by contributing to unstable hemodynamic parameters, hypercatabolism, hyperglycemia, infections, delirium, and posttraumatic stress. 2 Pain in ICU patients may also be part of a vicious circle implicating anxiety 3 and insomnia. 4 Moreover, pain has been linked to the post-ICU syndrome 5 and may become chronic in survivors, a situation associated with poor quality of life and poor psychological and physiological outcomes. 6Management of pain in patients with a critical illness is challenging.7 Opioids, the drug class of choice, are associated with marked side effects, including respiratory depression, hypotension, decreased gastrointestinal motility, delirium, and higher costs due to increased use of resources and prolonged stay in the ICU.8 Nociception, the perception of painful stimuli, entails a complex interaction among sensory, affective, and social components.9 Moreover, anxiety, fear, and negative expectations are common in critically ill patients and may contribute to heightened perception of pain.10 Thus, the multifactorial nature of ICU pain calls for approaches that address both physiological and psychosocial responses to pain. Current guidelines highlight the need to test and implement nonpharmacological strategies for pain treatment in critically ill patients.2 Interventions that elicit a relaxation ...

Relaxation for Critically ill Patient Outcomes andStress-coping Enhancement (REPOSE): a protocol for a pilot randomised trial of an integrative intervention to improve critically ill patients’ delirium and related outcomes

“…A recent systematic review shows favourable effects of relaxation and guided imagery (RGI) intervention in reducing pain, anxiety and length of stay in critically ill patients,18 whereas the relaxation-inducing effects of music in critical care have been well supported by evidence 19. In a pilot randomised controlled trial of the effects of a similar multimodal intervention on the incidence of pain and on a number of secondary outcomes, we observed significant decreases in pain incidence (RR=0.56, p=0.003) and severity (p<0.0001), systolic arterial pressure, anxiety, along with improved sleep quality 20…”

“…The protocol is based on a pilot study with 60 randomised patients,20 12 of which provided feedback regarding the desirability, burden and specific components of the intervention, study procedures and preferred outcomes. Participants’ feedback informed the design of the study, resulting in many significant changes.…”

“…The choice of a multimodal intervention (duration: 55 min) was based on an evidence-based literature review, its superiority to unidimensional approaches,23 the recommendations of the American Holistic Nurses Association24 and a successful pilot 20. According to the UK Medical Research Council guidance for complex intervention trials,25 development of the protocol included extensive theoretical work,10 two systematic reviews,18 26 modelling of outcomes, extensive consultations with groups of experts, one small feasibility and acceptability pilot (n=10 participants) and one larger pilot (n=60)20 and consultation with pilot participants and patients’ representatives. The intervention has been developed by the research team and a group of experts based at the University of Alberta and Cyprus University of Technology.…”

“…Physiological biomarkers (preintervention and postintervention): (A) serum inflammation biomarkers (high mobility group box 1 (HMGB-1) and C reactive protein (CRP) levels), (B) high frequency (HF) and low frequency (LF) components of heart rate variability (HRV) as measures of PNS status and (C) serum ACh levels, as a measure of PNS activation. The choice of biomarkers was based on the theoretical framework guiding this work (triggering of a relaxation parasympathetic response and attenuation of the inflammatory response; figure 1) and results of the pilot study,20 29 which showed alterations in biomarkers immediately postintervention and overtime, despite great variability in biomarker levels. The results will help us generate more informed hypotheses for a subsequent trial.…”

Investigating the Effects of Adaptive Stability Model on Headache of Patients with Migraine

“…Pharmacological methods are not considered economical methods as they are high-priced and have several side effects. However, nonpharmacological methods are recognized as the most effective methods for alleviating pain, some of which include nursing interventions (24), massage therapy (25), psychological interventions (26), tailored Web-based interventions (27), integrative nursing intervention (28), and music therapy (29). These are not highly priced methods and have no special side effects (30).…”