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

NCT02423252 | Unknown Early Phase 1

• 2 other identifiers: EX 043 - EP1EX 043 EPPSY-13
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (9)

• Change in Pain intensity [10-point numeric rating scale (NRS) scale]

  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]

  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]

  from baseline to 60 min over 1-5 days. (baseline: just before 1st day starting intervention time).

• Change in Systolic blood pressure (SBP)

  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)

  from baseline to 60 min (baseline: just before 1st day starting intervention time), over 1 to 5 days.

• Change in Plasma Neuropeptide Y level

  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

  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

  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

  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 Outcomes (21)

• Change in Diastolic blood pressure (DAP)

  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)

  from baseline to 30 and 60 min (baseline: just before 1st day starting intervention time),

• Change in Heart rate (HR)

  from baseline to 30 and 60 min (baseline: just before 1st day starting intervention time),

• Change in Respiration rate (RR)

  from baseline to 30 and 60 min (baseline: just before 1st day starting intervention time),

• Change in Temperature (TMP)

  from baseline to 30 and 60 min (baseline: just before 1st day starting intervention time),

Study Arms (2)

Intervention group

EXPERIMENTAL

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.; Other: No Intervention

Control

NO INTERVENTION

Patients in control group will receive standard care only. Same records and outcome measures with intervention group will apply for control group as well.

Interventions

Massage, Relaxation, Guided imagery and music listening. 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

Also known as: body-mind intervention

Intervention group

No Intervention 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)

Also known as: standard care, control

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr Elizabeth Papathanassoglou: lead
• Nicosia General Hospital: collaborator

Study Sites (1)

Nicosia General Hospital

Nicosia, Cyprus

RECRUITING

MeSH Terms

Conditions

Critical Illness

Interventions

Massage; Imagery, Psychotherapy; Standard of Care

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Mind-Body Therapies; Psychotherapy; Behavioral Disciplines and Activities; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Elizabeth DE Papathanassoglou, Phd

  Cyprus University of Technology

  STUDY DIRECTOR

Central Study Contacts

Maria Hadjibalassi, Phdc

CONTACT

0035799355610; maria.hadjibalassi@cut.ac.cy

Elizabeth DE Papathanassoglou, Phd

CONTACT

0035799824336; e.papathanassoglou@cut..ac.cy

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 28, 2015
• First Posted: April 22, 2015
• Study Start: March 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: May 1, 2016
• Last Updated: April 22, 2015

Record last verified: 2015-04

Locations

CY (1)