The purpose of this study is to investigate whether a psycho-cognitive nursing intervention including relaxation, guided imagery, touch and music listening can improve the clinical and psychological outcome of critically ill patients. The investigators hypothesize that, patients who receive the proposed psycho-cognitive nursing intervention will report lower stress, less pain and have altered level of stress neuropeptides in peripheral blood, lower levels of inflammatory molecules, less complications and better self reported lived experience than patients who receive standard care alone.
In previous research on the impact of stress on physiology, it has been shown that stress and its molecules may contribute to derangements prevalent in critical illness, including systemic inflammation, cellular stress, oxidative damage, endothelial dysfunction and coagulopathies which precipitate high mortality and morbidity. Investigators will examine whether a Psycho-cognitive nursing intervention to induce relaxation can improve patients outcomes. Sixty ICU patients with or without SIRS will be randomized to receive either standard care or a brief Psycho-cognitive Nursing Intervention, plus standard care, up to 5 days during ICU stay.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
In addition to standard care, patients in the intervention group will receive a 60 minutes individually delivered programme, administered once per day by a nurse (the researcher) for up to 5 days during staying in ICU. This session aims to induce relaxation and involves interpersonal support, touch/massage and through a headphone system relaxation and guided imagery exercises and music listening. Patients are provided a CD of the relaxation instructions, after their discharge, for own use
The control group will receive the standard care which includes the routine standard care provided by nurses, physiotherapists and intensivists or specialists (e.g. surgeons)
Nicosia General Hospital
Nicosia, Cyprus
RECRUITINGChange in Pain intensity [10-point numeric rating scale (NRS) scale]
Time frame: from baseline to 60 min over 1-5 days. (baseline: just before 1st day starting intervention time).
Change in Pain intensity [Behavioral pain scale (BPS) scale]
Time frame: from baseline to 60 min over 1-5 days. (baseline: just before 1st day starting intervention time).
Change in Pain intensity [critical-care pain observation tool (CPOT) scale]
Time frame: from baseline to 60 min over 1-5 days. (baseline: just before 1st day starting intervention time).
Change in Systolic blood pressure (SBP)
Time frame: from baseline to 30 and 60 min (baseline: just before 1st day starting intervention time), over 1 to 5 days.
Change in self reported Relaxation/calm levels (self- reported, 10 points NRS scale)
Time frame: from baseline to 60 min (baseline: just before 1st day starting intervention time), over 1 to 5 days.
Change in Plasma Neuropeptide Y level
Time frame: from baseline to 60 min (baseline: morning before 1st day intervention) (1st sample), morning after 1st day intervention (2nd sample), morning before and after intervention (1st and 2nd sample) on days 3rd and 5th.] [Designated as safety issue: No]
Change in Plasma Neuropeptide oxytocin level
Time frame: from baseline to 60 min (baseline: morning before 1st day intervention) (1st sample), morning after 1st day intervention (2nd sample), morning before and after intervention (1st and 2nd sample) on days 3rd and 5th.] [Designated as safety issue: No]
Change in Plasma Neuropeptide beta-endorphin level
Time frame: from baseline to 60 min (baseline: morning before 1st day intervention) (1st sample), morning after 1st day intervention (2nd sample), morning before and after intervention (1st and 2nd sample) on days 3rd and 5th.] [Designated as safety issue: No]
Change in Plasma Neuropeptide acetylcholine level
Investigators will study the differences of clinical and biochemical parameters between randomized groups of patients treated and not treated with the intervention. Differences in levels of neuropeptides and inflammatory markers among patient groups (intervention group and comparison) and group of healthy volunteers.
Time frame: from baseline to 60 min (baseline: morning before 1st day intervention) (1st sample), morning after 1st day intervention (2nd sample), morning before and after intervention (1st and 2nd sample) on days 3rd and 5th.] [Designated as safety issue: No]
Change in Diastolic blood pressure (DAP)
Time frame: from baseline to 30 and 60 min (baseline: just before 1st day starting intervention time), over 1 to 5 days.
Change in Mean arterial pressure (MAP)
Time frame: from baseline to 30 and 60 min (baseline: just before 1st day starting intervention time),
Change in Heart rate (HR)
Differences in levels of neuropeptides and inflammatory markers among patient groups (intervention group and comparison) and group of healthy volunteers.
Time frame: from baseline to 30 and 60 min (baseline: just before 1st day starting intervention time),
Change in Respiration rate (RR)
Time frame: from baseline to 30 and 60 min (baseline: just before 1st day starting intervention time),
Change in Temperature (TMP)
Time frame: from baseline to 30 and 60 min (baseline: just before 1st day starting intervention time),
Sequential organ failure assessment (SOFA) scores
Time frame: once on days 1, 3, 5 and on last day of stay in ICU.
Multiple organ disfunction syndrome (MODS) scores
Time frame: once on days 1, 3, 5 and on last day of stay in ICU.
Self reported quality of Sleep [10-point numeric rating scale (NRS) scale]
Time frame: morning before starting intervention (days 1-5)
Change in Self reported anxiety level [10-point numeric rating scale (NRS) scale]
Time frame: from baseline to 60 min over 1-5 days. (baseline: just before 1st day starting intervention time).
Change in Self reported fear level [10-point numeric rating scale (NRS)
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Time frame: from baseline to 60 min over 1-5 days. (baseline: just before 1st day starting intervention time).
Change in Self reported optimism level [10-point numeric rating scale (NRS)
Time frame: from baseline to 60 min over 1-5 days. (baseline: just before 1st day starting intervention time).
Change in Self reported distress level [10-point numeric rating scale (NRS)]
Time frame: from baseline to 60 min over 1-5 days. (baseline: just before 1st day starting intervention time).
Richmond agitation-sedation scale (RASS) score
Time frame: days 1, 2, 3, 4, 5.
Change in Plasma levels of Inflammatory marker Interleukin-6
Time frame: from baseline to 60 min (baseline: morning before 1st day intervention) (1st sample), morning after 1st day intervention (2nd sample), morning before and after intervention (1st and 2nd sample) on days 3rd and 5th.] [Designated as safety issue: No]
Change in Plasma levels of Inflammatory marker Interleukin-8
Time frame: from baseline to 60 min (baseline: morning before 1st day intervention) (1st sample), morning after 1st day intervention (2nd sample), morning before and after intervention (1st and 2nd sample) on days 3rd and 5th.] [Designated as safety issue: No]
Change in Plasma levels of Inflammatory marker soluble fas ligand (sfas)
Time frame: from baseline to 60 min (baseline: morning before 1st day intervention) (1st sample), morning after 1st day intervention (2nd sample), morning before and after intervention (1st and 2nd sample) on days 3rd and 5th.] [Designated as safety issue: No]
Change in Plasma inflammatory marker levels High mobility group box-1 (HMGB-1)]
Investigators will study the differences of clinical and biochemical parameters between randomized groups of patients treated and not treated with the intervention. Differences in levels of neuropeptides and inflammatory markers among patient groups (intervention group and comparison) and group of healthy volunteers.
Time frame: from baseline to 60 min (baseline: morning before 1st day intervention) (1st sample), morning after 1st day intervention (2nd sample), morning before and after intervention (1st and 2nd sample) on days 3rd and 5th.] [Designated as safety issue: No]
assessment of psychological distress (ICUESS: Intensive Care Unit Environmental Stressor Scale, self-assessment in a 1-10 numerical analogue scale).
Time frame: within 48 hours post discharge from ICU
Assessment of symptoms of post traumatic stress disorder (PTSD) using DTS (Davidson Trauma Scale)
Time frame: one month and six months after hospital discharge
assessment of quality of life using Short Form 36 version2 scale (SF36v2)
Time frame: one month and six months after discharge
Exploration of lived experience of critical illness (phenomenological interviews)
Time frame: one month and six months after discharge