NCT02423252

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

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

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Dr Elizabeth Papathanassoglou · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Critical Illness
• Stress
• Inflammatory Response

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2015-03-01
• Primary completion: 2015-11-01
• Completion: 2016-05-01
• First posted: 2015-04-22
• Last updated: 2015-04-22

Locations

1 site across 1 country: Cyprus