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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Critical Illness Stress Inflammatory Response

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Intervention group

Intervention: Massage, Relaxation, imagery, music. Patients in Intervention group will receive standard care plus massage, relaxation, guided imagery and music listening

Group Type EXPERIMENTAL

Massage, Relaxation, Guided imagery and music listening.

Intervention Type BEHAVIORAL

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

No Intervention

Intervention Type OTHER

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)

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

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)

Intervention Type OTHER

Other Intervention Names

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body-mind intervention standard care, control

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes