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

Stress Clinical Trial

Official title:

The Effects of a Psycho-cognitive Nursing Intervention on Clinical and Psychological Outcomes of Critically Ill Patients: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02423252
• Other study ID #: EX 043 - EP1
• Secondary ID: EX 043 EPPSY-13
• Status: Recruiting
• Phase: Phase 0
• First received: March 28, 2015
• Last updated: April 17, 2015
• Start date: March 2015
• Est. completion date: May 2016

Study information

• Verified date: April 2015
• Source: Cyprus University of Technology
• Contact: Maria Hadjibalassi, Phdc
• Phone: 0035799355610
• Email: maria.hadjibalassi[@]cut.ac.cy
• Is FDA regulated: No
• Health authority: Cyprus: Cyprus National Bioethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness
• Inflammatory Response
• Stress

Intervention

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

Other:
• No Intervention
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)

Locations

Country	Name	City	State
Cyprus	Nicosia General Hospital	Nicosia

Sponsors (2)

Lead Sponsor	Collaborator
Dr Elizabeth Papathanassoglou	Nicosia General Hospital

Country where clinical trial is conducted

Cyprus, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pain intensity [10-point numeric rating scale (NRS) scale]		from baseline to 60 min over 1-5 days. (baseline: just before 1st day starting intervention time).	No
Primary	Change in Pain intensity [Behavioral pain scale (BPS) scale]		from baseline to 60 min over 1-5 days. (baseline: just before 1st day starting intervention time).	No
Primary	Change in Pain intensity [critical-care pain observation tool (CPOT) scale]		from baseline to 60 min over 1-5 days. (baseline: just before 1st day starting intervention time).	No
Primary	Change in Systolic blood pressure (SBP)		from baseline to 30 and 60 min (baseline: just before 1st day starting intervention time), over 1 to 5 days.	No
Primary	Change in self reported Relaxation/calm levels (self- reported, 10 points NRS scale)		from baseline to 60 min (baseline: just before 1st day starting intervention time), over 1 to 5 days.	No
Primary	Change in Plasma Neuropeptide Y level		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]	No
Primary	Change in Plasma Neuropeptide oxytocin level		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]	No
Primary	Change in Plasma Neuropeptide beta-endorphin level		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]	No
Primary	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.	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]	No
Secondary	Change in Diastolic blood pressure (DAP)		from baseline to 30 and 60 min (baseline: just before 1st day starting intervention time), over 1 to 5 days.	No
Secondary	Change in Mean arterial pressure (MAP)		from baseline to 30 and 60 min (baseline: just before 1st day starting intervention time),	No
Secondary	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.	from baseline to 30 and 60 min (baseline: just before 1st day starting intervention time),	No
Secondary	Change in Respiration rate (RR)		from baseline to 30 and 60 min (baseline: just before 1st day starting intervention time),	No
Secondary	Change in Temperature (TMP)		from baseline to 30 and 60 min (baseline: just before 1st day starting intervention time),	No
Secondary	Sequential organ failure assessment (SOFA) scores		once on days 1, 3, 5 and on last day of stay in ICU.	No
Secondary	Multiple organ disfunction syndrome (MODS) scores		once on days 1, 3, 5 and on last day of stay in ICU.	No
Secondary	Self reported quality of Sleep [10-point numeric rating scale (NRS) scale]		morning before starting intervention (days 1-5)	No
Secondary	Change in Self reported anxiety level [10-point numeric rating scale (NRS) scale]		from baseline to 60 min over 1-5 days. (baseline: just before 1st day starting intervention time).	No
Secondary	Change in Self reported fear level [10-point numeric rating scale (NRS)		from baseline to 60 min over 1-5 days. (baseline: just before 1st day starting intervention time).	No
Secondary	Change in Self reported optimism level [10-point numeric rating scale (NRS)		from baseline to 60 min over 1-5 days. (baseline: just before 1st day starting intervention time).	No
Secondary	Change in Self reported distress level [10-point numeric rating scale (NRS)]		from baseline to 60 min over 1-5 days. (baseline: just before 1st day starting intervention time).	No
Secondary	Richmond agitation-sedation scale (RASS) score		days 1, 2, 3, 4, 5.	No
Secondary	Change in Plasma levels of Inflammatory marker Interleukin-6		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]	No
Secondary	Change in Plasma levels of Inflammatory marker Interleukin-8		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]	No
Secondary	Change in Plasma levels of Inflammatory marker soluble fas ligand (sfas)		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]	No
Secondary	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.	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]	No
Secondary	assessment of psychological distress (ICUESS: Intensive Care Unit Environmental Stressor Scale, self-assessment in a 1-10 numerical analogue scale).		within 48 hours post discharge from ICU	No
Secondary	Assessment of symptoms of post traumatic stress disorder (PTSD) using DTS (Davidson Trauma Scale)		one month and six months after hospital discharge	No
Secondary	assessment of quality of life using Short Form 36 version2 scale (SF36v2)		one month and six months after discharge	No
Secondary	Exploration of lived experience of critical illness (phenomenological interviews)		one month and six months after discharge	No