Reducing Intensive Care Unit (ICU) Related Anxiety Through a Structured Information Program

Reducing ICU Related Anxiety Through a Structured Information Program. A Randomized Controlled Clinical Trial

According to current evidence and psychological theorizing, the provision of information seems to be a promising way to reduce the anxiety of patients that is related to their scheduled ICU stay. An ICU-specific information program will be investigated in a randomized controlled clinical trial involving 120 patients undergoing elective open heart surgery and 20 patients undergoing abdominal surgery. It is expected that the patients in the test group will experience less anxiety and ICU related discomfort than patients in the control group.

Study Overview

• Status: Completed
• Conditions: Heart Diseases
• Intervention / Treatment: Behavioral: ICU-specific information program

Detailed Description

Objective: According to current evidence and psychological theorizing the provision of information seems to be a promising way to reduce anxiety of patients. In the case of surgical patients, admission to the intensive care unit (ICU) is strongly associated with uncertainty, unpredictability and anxiety for the patient. Thus, ICU-specific information could have a high clinical impact. For this reason this study will evaluate the efficacy of an ICU-specific information program for patients who undergo elective cardiac, abdominal or thoracic surgery and are scheduled for ICU stay.

Methods: The trial is designed as a prospective randomized controlled trial including an intervention and a control group. The control group receives the standard preparation currently conducted by surgeons and anesthesists. The intervention group additionally receives a standardized information program with specific procedural, sensory and coping information about the ICU. In addition the moderating effect of certain personality characteristics (need for cognition, high trait anxiety) will be investigated to identify groups of patients who benefit most from the information program.

Expected Results: A clinically relevant difference in anxiety and unpleasant experiences related to the ICU is expected after discharge from the ICU. Power calculation (alpha = 0.05; beta = 0.20; delta = 8.50 score points) resulted in a required sample size of N = 120 cardiac surgical patients (n = 60 vs. n = 60). Furthermore, N = 20 abdominal or thoracic surgical patients will be recruited (n = 10 vs. n = 10).

Conclusion: The proposed study promises to strengthen evidence on the effects of a specific, concise information program and thus should contribute to evidence based nursing (EBN).

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hessen
    • Marburg, Hessen, Germany, 35033
      • University Hospital Marburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Elective open heart or abdominal surgery including scheduled ICU stay
• Informed consent

Exclusion Criteria:

• Elective surgery without ICU stay
• Informed consent denied

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Experimental: Intervention group	Behavioral: ICU-specific information program; The intervention group receives a standardized information program with specific procedural, sensory and coping information about the ICU in addition to standard information given by surgeons and anesthetists.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Patient self-reported anxiety	after admission on standard ward
ICU related discomfort	after admission on standard ward

Secondary Outcome Measures

Outcome Measure	Time Frame
Objective health status parameters	postoperative phase of hospital stay
Overall satisfaction with care	3 months after discharge
Quality of life	3 months after discharge

Collaborators and Investigators

• Sponsor: Philipps University Marburg Medical Center
• Collaborators: Pflegeverbund Mitte-Süd; Stabstelle Pflegeforschung; Institut für Theoretische Chirurgie; Klinik für Herzchirurgie; Klinik für VTG-Chirurgie
• Investigators: Principal Investigator: Thomas Neubert, PhD, Stabstelle Pflegeforschung, Universitätsklinikum Marburg

Publications and helpful links

General Publications

• Berg A, Fleischer S, Koller M, Neubert TR. Preoperative information for ICU patients to reduce anxiety during and after the ICU-stay: protocol of a randomized controlled trial [NCT00151554]. BMC Nurs. 2006 Mar 8;5:4. doi: 10.1186/1472-6955-5-4.

Study record dates

Study Major Dates

• Study Start: February 1, 2005
• Primary Completion (Actual): September 1, 2006
• Study Completion (Actual): December 1, 2006

Study Registration Dates

• First Submitted: September 7, 2005
• First Submitted That Met QC Criteria: September 7, 2005
• First Posted (Estimate): September 9, 2005

Study Record Updates

• Last Update Posted (Estimate): July 29, 2010
• Last Update Submitted That Met QC Criteria: July 28, 2010
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Keywords: Anxiety; Randomized Controlled Trial (RCT); Intensive Care Unit (ICU); Chronic heart disease; Preoperative Information
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: PflegeverbundMarburg2; BMBF grant 01GT0303