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

April 17, 2015 updated by: Dr Elizabeth Papathanassoglou

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Cyprus
      • Nicosia, Cyprus
        • Recruiting
        • Nicosia General Hospital
        • Principal Investigator:
          • Maria Hadjibalassi, Phdc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention group
Intervention: Massage, Relaxation, imagery, music. Patients in Intervention group will receive standard care plus massage, relaxation, guided imagery and music listening
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 Names:
  • body-mind intervention
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)
Other Names:
  • standard care, control
No Intervention: Control
Patients in control group will receive standard care only. Same records and outcome measures with intervention group will apply for control group as well.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
from baseline to 60 min over 1-5 days. (baseline: just before 1st day starting intervention time).
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).
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).
from baseline to 60 min over 1-5 days. (baseline: just before 1st day starting intervention time).
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.
from baseline to 30 and 60 min (baseline: just before 1st day starting intervention time), over 1 to 5 days.
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.
from baseline to 60 min (baseline: just before 1st day starting intervention time), over 1 to 5 days.
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]
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 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]
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 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]
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]

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]

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
from baseline to 30 and 60 min (baseline: just before 1st day starting intervention time), over 1 to 5 days.
Change in Mean arterial pressure (MAP)
Time Frame: from baseline to 30 and 60 min (baseline: just before 1st day starting intervention time),
from baseline to 30 and 60 min (baseline: just before 1st day starting intervention time),
Change in Heart rate (HR)
Time Frame: from baseline to 30 and 60 min (baseline: just before 1st day starting intervention time),
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),
Change in Respiration rate (RR)
Time Frame: from baseline to 30 and 60 min (baseline: just before 1st day starting intervention time),
from baseline to 30 and 60 min (baseline: just before 1st day starting intervention time),
Change in Temperature (TMP)
Time Frame: from baseline to 30 and 60 min (baseline: just before 1st day starting intervention time),
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.
once on days 1, 3, 5 and on last day of stay in ICU.
Multiple organ disfunction syndrome (MODS) scores
Time Frame: once on days 1, 3, 5 and on last day of stay in ICU.
once on days 1, 3, 5 and on last day of stay in ICU.
Self reported quality of Sleep [10-point numeric rating scale (NRS) scale]
Time Frame: morning before starting intervention (days 1-5)
morning before starting intervention (days 1-5)
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).
from baseline to 60 min over 1-5 days. (baseline: just before 1st day starting intervention time).
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).
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).
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).
from baseline to 60 min over 1-5 days. (baseline: just before 1st day starting intervention time).
Richmond agitation-sedation scale (RASS) score
Time Frame: days 1, 2, 3, 4, 5.
days 1, 2, 3, 4, 5.
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]
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 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]
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 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]
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 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]

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]
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
within 48 hours post discharge from ICU
Assessment of symptoms of post traumatic stress disorder (PTSD) using DTS (Davidson Trauma Scale)
Time Frame: one month and six months after hospital discharge
one month and six months after hospital discharge
assessment of quality of life using Short Form 36 version2 scale (SF36v2)
Time Frame: one month and six months after discharge
one month and six months after discharge
Exploration of lived experience of critical illness (phenomenological interviews)
Time Frame: one month and six months after discharge
one month and six months after discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dr Elizabeth Papathanassoglou

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Nicosia General Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Elizabeth DE Papathanassoglou, Phd, Cyprus University of Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2015

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 28, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 22, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 22, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EX 043 - EP1
  • EX 043 EPPSY-13 (Other Grant/Funding Number: Grant:Cyprus University of Technology/Funding number: EX 043)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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