Effects of a Psycho-cognitive Nursing Intervention on Patients' Outcomes in Critical Illness

• Register: ClinicalTrials.gov
• Last refreshed on: 28 April 2015
• Main ID: NCT02423252
• Date of registration: 28/03/2015
• Prospective Registration: No
• Primary sponsor: Dr Elizabeth Papathanassoglou
• Public title: Effects of a Psycho-cognitive Nursing Intervention on Patients' Outcomes in Critical Illness
• Scientific title: The Effects of a Psycho-cognitive Nursing Intervention on Clinical and Psychological Outcomes of Critically Ill Patients: A Randomized Controlled Trial
• Date of first enrolment: March 2015
• Target sample size: 60
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT02423252
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 0

Countries of recruitment

Cyprus

Contacts

• Name: Maria Hadjibalassi, Phdc

• Name: Elizabeth DE Papathanassoglou, Phd
• Affiliation: Cyprus University of Technology

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Inflammatory Response

Critical Illness

Stress

Intervention(s)

Behavioral: Massage, Relaxation, Guided imagery and music listening.

Other: No Intervention

Primary Outcome(s)

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 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 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 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 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 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 [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 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.]

Secondary Outcome(s)

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 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).]

Self reported quality of Sleep [10-point numeric rating scale (NRS) scale] [Time Frame: morning before starting intervention (days 1-5)]

assessment of quality of life using Short Form 36 version2 scale (SF36v2) [Time Frame: one month and six months after discharge]

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]]

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]

Change in Mean arterial pressure (MAP) [Time Frame: from baseline to 30 and 60 min (baseline: just before 1st day starting intervention time),]

Assessment of symptoms of post traumatic stress disorder (PTSD) using DTS (Davidson Trauma Scale) [Time Frame: one month and six months after hospital discharge]

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 Respiration rate (RR) [Time Frame: from baseline to 30 and 60 min (baseline: just before 1st day starting intervention time),]

Exploration of lived experience of critical illness (phenomenological interviews) [Time Frame: one month and six months after discharge]

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 Heart rate (HR) [Time Frame: from baseline to 30 and 60 min (baseline: just before 1st day starting intervention time),]

Multiple organ disfunction syndrome (MODS) scores [Time Frame: once on days 1, 3, 5 and on last day of stay in ICU.]

Change in Self reported fear 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 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 Plasma inflammatory marker levels High mobility group box-1 (HMGB-1)] [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 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.]

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]]

Richmond agitation-sedation scale (RASS) score [Time Frame: days 1, 2, 3, 4, 5.]

Secondary ID(s)

EX 043 EPPSY-13

EX 043 - EP1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Nicosia General Hospital