Back to resultsEffects of a Psycho-cognitive Nursing Intervention on Patients' Outcomes in Critical Illness
Primary Purpose
Critical Illness, Stress, Inflammatory Response
Status
Unknown status
Phase
Early Phase 1
Locations
Cyprus
Study Type
Interventional
Intervention
Massage, Relaxation, Guided imagery and music listening.
No Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Critical Illness focused on measuring 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
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
Sites / Locations
- Nicosia General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control
Arm Description
Intervention: Massage, Relaxation, imagery, music. Patients in Intervention group will receive standard care plus massage, relaxation, guided imagery and music listening
Patients in control group will receive standard care only. Same records and outcome measures with intervention group will apply for control group as well.
Outcomes
Primary Outcome Measures
Change in Pain intensity [10-point numeric rating scale (NRS) scale]
Change in Pain intensity [Behavioral pain scale (BPS) scale]
Change in Pain intensity [critical-care pain observation tool (CPOT) scale]
Change in Systolic blood pressure (SBP)
Change in self reported Relaxation/calm levels (self- reported, 10 points NRS scale)
Change in Plasma Neuropeptide Y level
Change in Plasma Neuropeptide oxytocin level
Change in Plasma Neuropeptide beta-endorphin level
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.
Secondary Outcome Measures
Change in Diastolic blood pressure (DAP)
Change in Mean arterial pressure (MAP)
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.
Change in Respiration rate (RR)
Change in Temperature (TMP)
Sequential organ failure assessment (SOFA) scores
Multiple organ disfunction syndrome (MODS) scores
Self reported quality of Sleep [10-point numeric rating scale (NRS) scale]
Change in Self reported anxiety level [10-point numeric rating scale (NRS) scale]
Change in Self reported fear level [10-point numeric rating scale (NRS)
Change in Self reported optimism level [10-point numeric rating scale (NRS)
Change in Self reported distress level [10-point numeric rating scale (NRS)]
Richmond agitation-sedation scale (RASS) score
Change in Plasma levels of Inflammatory marker Interleukin-6
Change in Plasma levels of Inflammatory marker Interleukin-8
Change in Plasma levels of Inflammatory marker soluble fas ligand (sfas)
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.
assessment of psychological distress (ICUESS: Intensive Care Unit Environmental Stressor Scale, self-assessment in a 1-10 numerical analogue scale).
Assessment of symptoms of post traumatic stress disorder (PTSD) using DTS (Davidson Trauma Scale)
assessment of quality of life using Short Form 36 version2 scale (SF36v2)
Exploration of lived experience of critical illness (phenomenological interviews)
Full Information
NCT ID
NCT02423252
First Posted
March 28, 2015
Last Updated
April 17, 2015
Sponsor
Dr Elizabeth Papathanassoglou
Collaborators
Nicosia General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02423252
Brief Title
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
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
November 2015 (Anticipated)
Study Completion Date
May 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr Elizabeth Papathanassoglou
Collaborators
Nicosia General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Intervention: Massage, Relaxation, imagery, music. Patients in Intervention group will receive standard care plus massage, relaxation, guided imagery and music listening
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients in control group will receive standard care only. Same records and outcome measures with intervention group will apply for control group as well.
Intervention Type
Behavioral
Intervention Name(s)
Massage, Relaxation, Guided imagery and music listening.
Other Intervention Name(s)
body-mind intervention
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
No Intervention
Other Intervention Name(s)
standard care, control
Intervention Description
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)
Primary Outcome Measure Information:
Title
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).
Title
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).
Title
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).
Title
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.
Title
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.
Title
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]
Title
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]
Title
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]
Title
Change in Plasma Neuropeptide acetylcholine level
Description
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]
Secondary Outcome Measure Information:
Title
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.
Title
Change in Mean arterial pressure (MAP)
Time Frame
from baseline to 30 and 60 min (baseline: just before 1st day starting intervention time),
Title
Change in Heart rate (HR)
Description
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),
Title
Change in Respiration rate (RR)
Time Frame
from baseline to 30 and 60 min (baseline: just before 1st day starting intervention time),
Title
Change in Temperature (TMP)
Time Frame
from baseline to 30 and 60 min (baseline: just before 1st day starting intervention time),
Title
Sequential organ failure assessment (SOFA) scores
Time Frame
once on days 1, 3, 5 and on last day of stay in ICU.
Title
Multiple organ disfunction syndrome (MODS) scores
Time Frame
once on days 1, 3, 5 and on last day of stay in ICU.
Title
Self reported quality of Sleep [10-point numeric rating scale (NRS) scale]
Time Frame
morning before starting intervention (days 1-5)
Title
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).
Title
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).
Title
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).
Title
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).
Title
Richmond agitation-sedation scale (RASS) score
Time Frame
days 1, 2, 3, 4, 5.
Title
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]
Title
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]
Title
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]
Title
Change in Plasma inflammatory marker levels High mobility group box-1 (HMGB-1)]
Description
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]
Title
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
Title
Assessment of symptoms of post traumatic stress disorder (PTSD) using DTS (Davidson Trauma Scale)
Time Frame
one month and six months after hospital discharge
Title
assessment of quality of life using Short Form 36 version2 scale (SF36v2)
Time Frame
one month and six months after discharge
Title
Exploration of lived experience of critical illness (phenomenological interviews)
Time Frame
one month and six months after discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Hadjibalassi, Phdc
Phone
0035799355610
Email
maria.hadjibalassi@cut.ac.cy
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth DE Papathanassoglou, Phd
Phone
0035799824336
Email
e.papathanassoglou@cut..ac.cy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth DE Papathanassoglou, Phd
Organizational Affiliation
Cyprus University of Technology
Official's Role
Study Director
Facility Information:
Facility Name
Nicosia General Hospital
City
Nicosia
Country
Cyprus
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Hadjibalassi, Phdc
12. IPD Sharing Statement
Learn more about this trial
Effects of a Psycho-cognitive Nursing Intervention on Patients' Outcomes in Critical Illness
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