Clinical trial NCT02423252: Effects of a Psycho-cognitive Nursing Intervention on Patients' Outcomes in Critical Illness
Official title: The Effects of a Psycho-cognitive Nursing Intervention on Clinical and Psychological Outcomes of Critically Ill Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Critical Illness
Stress
Inflammatory Response
Keywords: Critical illness
Intervention
RCT
Relaxation
Guided imagery
Touch/Massage
Music listening
Neuropeptides
Inflammatory molecules
Post-traumatic stress
Critical care nurse
Psychocognitive nursing intervention
Interpersonal support
Lead sponsor: Cyprus University of Technology
Sponsor class: OTHER
Collaborators: name: Nicosia General Hospital
First posted: 2015-04-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Critically ill patients
* Understand Greek language
* Age over 18 years
* They have Richmond Agitation Sedation Scale rate: -3 +3
* Have an Arterial line in place

Exclusion Criteria:

* Patient who is expected to stay less than 24 hours in Critical care unit
* Have history of psychiatric disturbances
* Their condition does not permit use of headphones
* Have hearing impairment
* Receive neuro-muscular blockers
* Are confused
* Patients under universal conduct precautions

Primary outcomes:
measure: Change in Pain intensity [10-point numeric rating scale (NRS) scale]
timeFrame: from baseline to 60 min over 1-5 days. (baseline: just before 1st day starting intervention time).
measure: Change in Pain intensity [Behavioral pain scale (BPS) scale]
timeFrame: from baseline to 60 min over 1-5 days. (baseline: just before 1st day starting intervention time).
measure: Change in Pain intensity [critical-care pain observation tool (CPOT) scale]
timeFrame: from baseline to 60 min over 1-5 days. (baseline: just before 1st day starting intervention time).
measure: Change in Systolic blood pressure (SBP)
timeFrame: from baseline to 30 and 60 min (baseline: just before 1st day starting intervention time), over 1 to 5 days.
measure: Change in self reported Relaxation/calm levels (self- reported, 10 points NRS scale)
timeFrame: from baseline to 60 min (baseline: just before 1st day starting intervention time), over 1 to 5 days.
measure: Change in Plasma Neuropeptide Y level
timeFrame: 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]
measure: Change in Plasma Neuropeptide oxytocin level
timeFrame: 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]
measure: Change in Plasma Neuropeptide beta-endorphin level
timeFrame: 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]
measure: Change in Plasma Neuropeptide acetylcholine level
timeFrame: 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]
Secondary outcomes:
measure: Change in Diastolic blood pressure (DAP)
timeFrame: from baseline to 30 and 60 min (baseline: just before 1st day starting intervention time), over 1 to 5 days.
measure: Change in Mean arterial pressure (MAP)
timeFrame: from baseline to 30 and 60 min (baseline: just before 1st day starting intervention time),
measure: Change in Heart rate (HR)
timeFrame: from baseline to 30 and 60 min (baseline: just before 1st day starting intervention time),
measure: Change in Respiration rate (RR)
timeFrame: from baseline to 30 and 60 min (baseline: just before 1st day starting intervention time),
measure: Change in Temperature (TMP)
timeFrame: from baseline to 30 and 60 min (baseline: just before 1st day starting intervention time),
measure: Sequential organ failure assessment (SOFA) scores
timeFrame: once on days 1, 3, 5 and on last day of stay in ICU.
measure: Multiple organ disfunction syndrome (MODS) scores
timeFrame: once on days 1, 3, 5 and on last day of stay in ICU.
measure: Self reported quality of Sleep [10-point numeric rating scale (NRS) scale]
timeFrame: morning before starting intervention (days 1-5)
measure: Change in Self reported anxiety level [10-point numeric rating scale (NRS) scale]
timeFrame: from baseline to 60 min over 1-5 days. (baseline: just before 1st day starting intervention time).
measure: Change in Self reported fear level [10-point numeric rating scale (NRS)
timeFrame: from baseline to 60 min over 1-5 days. (baseline: just before 1st day starting intervention time).
measure: Change in Self reported optimism level [10-point numeric rating scale (NRS)
timeFrame: from baseline to 60 min over 1-5 days. (baseline: just before 1st day starting intervention time).
measure: Change in Self reported distress level [10-point numeric rating scale (NRS)]
timeFrame: from baseline to 60 min over 1-5 days. (baseline: just before 1st day starting intervention time).
measure: Richmond agitation-sedation scale (RASS) score
timeFrame: days 1, 2, 3, 4, 5.
measure: Change in Plasma levels of Inflammatory marker Interleukin-6
timeFrame: 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]
measure: Change in Plasma levels of Inflammatory marker Interleukin-8
timeFrame: 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]
measure: Change in Plasma levels of Inflammatory marker soluble fas ligand (sfas)
timeFrame: 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]
measure: Change in Plasma inflammatory marker levels High mobility group box-1 (HMGB-1)]
timeFrame: 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]
measure: assessment of psychological distress (ICUESS: Intensive Care Unit Environmental Stressor Scale, self-assessment in a 1-10 numerical analogue scale).
timeFrame: within 48 hours post discharge from ICU
measure: Assessment of symptoms of post traumatic stress disorder (PTSD) using DTS (Davidson Trauma Scale)
timeFrame: one month and six months after hospital discharge
measure: assessment of quality of life using Short Form 36 version2 scale (SF36v2)
timeFrame: one month and six months after discharge
measure: Exploration of lived experience of critical illness (phenomenological interviews)
timeFrame: one month and six months after discharge
Other outcomes:
Locations:
city: Nicosia
country: Cyprus
facility: Nicosia General Hospital
Study officials:
affiliation: Cyprus University of Technology
name: Elizabeth DE Papathanassoglou, Phd
role: STUDY_DIRECTOR
References: