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
2 other identifiers
interventional
140
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2005
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 7, 2005
CompletedFirst Posted
Study publicly available on registry
September 9, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedJuly 29, 2010
July 1, 2010
1.6 years
September 7, 2005
July 28, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Patient self-reported anxiety
after admission on standard ward
ICU related discomfort
after admission on standard ward
Secondary Outcomes (3)
Objective health status parameters
postoperative phase of hospital stay
Overall satisfaction with care
3 months after discharge
Quality of life
3 months after discharge
Study Arms (2)
Control group
NO INTERVENTIONIntervention group
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- Elective open heart or abdominal surgery including scheduled ICU stay
- Informed consent
You may not qualify if:
- Elective surgery without ICU stay
- Informed consent denied
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Philipps University Marburglead
- Pflegeverbund Mitte-Südcollaborator
- Stabstelle Pflegeforschungcollaborator
- Institut für Theoretische Chirurgiecollaborator
- Klinik für Herzchirurgiecollaborator
- Klinik für VTG-Chirurgiecollaborator
Study Sites (1)
University Hospital Marburg
Marburg, Hesse, 35033, Germany
Related Publications (1)
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.
PMID: 16524468BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Neubert, PhD
Stabstelle Pflegeforschung, Universitätsklinikum Marburg
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 7, 2005
First Posted
September 9, 2005
Study Start
February 1, 2005
Primary Completion
September 1, 2006
Study Completion
December 1, 2006
Last Updated
July 29, 2010
Record last verified: 2010-07