Structured Information During the Intensive Care Unit Stay
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ClinicalTrials.gov Identifier: NCT00764933 |
Recruitment Status :
Completed
First Posted : October 2, 2008
Last Update Posted : June 3, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Anxiety | Behavioral: Structured information Other: Unspecific conversation | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 211 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | A Randomized Controlled Multi Center Study to Evaluate the Efficacy of a Structured Information Program During ICU Stay |
Study Start Date : | January 2008 |
Actual Primary Completion Date : | December 2009 |
Actual Study Completion Date : | March 2010 |
Arm | Intervention/treatment |
---|---|
Experimental: 1
Structured information
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Behavioral: Structured information
Participants will receive structured information about their ICU-stay and course of therapy and care. They get information about procedures, sensory impressions and coping strategies. The intervention will last about 10 to 15 minutes depending on the state of the participant. |
Sham Comparator: 2
Unspecific conversation
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Other: Unspecific conversation
Participants will receive a short conversation with the study personnel. This conversation will last about 10 to 15 minutes. No specific informations will be given about procedures, sensory impressions or coping strategies. Control intervention is designed to control for personal attention and care. |
- Patient self-reported anxiety [ Time Frame: First three days on ICU and/or within 24 hours after ICU discharge ]
- Confusion Assessment Method for the ICU (CAM-ICU) [ Time Frame: Within first three days on ICU ]
- Patient self reported health-related quality of life [ Time Frame: 3 months after discharge from hospital ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Elective open heart or abdominal surgery including scheduled ICU stay
- Heart or abdominal surgery or internal patients with non-scheduled ICU stay
- Informed consent
Exclusion Criteria:
- Reduced sensual perception
- Cognitive impairment
- Not able to answer a questionnaire (e.g. illiterate)
- Lying in the same room with another patient already included

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00764933
Germany | |
Sana Herzchirurgische Klinik Stuttgart GmbH | |
Stuttgart, BW, Germany | |
Universitätsklinikum Gießen und Marburg, Kooperationsstudien Pflegedienst/Ärztlicher Dienst, Klinik für Visceral-, Thorax- und Gefäßchirurgie, Klinik für Herz- und thorakale Gefäßchirurgie, Standort Marburg | |
Marburg, HES, Germany | |
Institut für Gesundheits- und Pflegewissenschaft, Universitätsklinik für Anästhesiologie und operative Intensivmedizin, Medizinische Fakultät, Martin-Luther-Universität Halle-Wittenberg | |
Halle, SAN, Germany, 06097 |
Responsible Party: | Prof. Dr. phil habil Johann Behrens, Martin-Luther-Universität Halle-Wittenberg |
ClinicalTrials.gov Identifier: | NCT00764933 |
Other Study ID Numbers: |
PfVMS-T4 |
First Posted: | October 2, 2008 Key Record Dates |
Last Update Posted: | June 3, 2010 |
Last Verified: | January 2010 |
information programme anxiety reduction multicenter trial intensive care critical care |