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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


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
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