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

Dr Elizabeth Papathanassoglou

Status and phase: Unknown; Early Phase 1

Conditions: Critical Illness; Inflammatory Response; Stress

Treatments: Other: No Intervention; Behavioral: Massage, Relaxation, Guided imagery and music listening.

Study type: Interventional

Funder types: Other

Identifiers

NCT02423252

EX 043 EPPSY-13 (Other Grant/Funding Number)

EX 043 - EP1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Intervention group

Experimental group

Description:

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

Treatment:

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

Other: No Intervention

Control

No Intervention group

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.