NCT00764933

Brief Summary

The purpose of this study is to test whether a structured information program at the beginning of the ICU-stay is effective to reduce ICU related anxiety and discomfort.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
211

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
Completed

Started Jan 2008

Typical duration for not_applicable anxiety

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 1, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

June 3, 2010

Status Verified

January 1, 2010

Enrollment Period

1.9 years

First QC Date

October 1, 2008

Last Update Submit

June 1, 2010

Conditions

Anxiety

Keywords

information programmeanxiety reductionmulticenter trialintensive carecritical care

Outcome Measures

Primary Outcomes (1)

  • Patient self-reported anxiety

    First three days on ICU and/or within 24 hours after ICU discharge

Secondary Outcomes (2)

  • Confusion Assessment Method for the ICU (CAM-ICU)

    Within first three days on ICU

  • Patient self reported health-related quality of life

    3 months after discharge from hospital

Study Arms (2)

1

EXPERIMENTAL

Structured information

Behavioral: Structured information

2

SHAM COMPARATOR

Unspecific conversation

Other: Unspecific conversation

Interventions

Structured informationBEHAVIORAL

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.

1
Unspecific conversationOTHER

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.

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective open heart or abdominal surgery including scheduled ICU stay
  • Heart or abdominal surgery or internal patients with non-scheduled ICU stay
  • Informed consent

You may not qualify if:

  • Reduced sensual perception
  • Cognitive impairment
  • Not able to answer a questionnaire (e.g. illiterate)
  • Lying in the same room with another patient already included

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Sana Herzchirurgische Klinik Stuttgart GmbH

Stuttgart, Baden-Wurttemberg, Germany

Location

Universitätsklinikum Gießen und Marburg, Kooperationsstudien Pflegedienst/Ärztlicher Dienst, Klinik für Visceral-, Thorax- und Gefäßchirurgie, Klinik für Herz- und thorakale Gefäßchirurgie, Standort Marburg

Marburg, Hesse, Germany

Location

Institut für Gesundheits- und Pflegewissenschaft, Universitätsklinik für Anästhesiologie und operative Intensivmedizin, Medizinische Fakultät, Martin-Luther-Universität Halle-Wittenberg

Halle, SAN, 06097, Germany

Location

Related Publications (2)

  • Fleischer S, Berg A, Behrens J, Kuss O, Becker R, Horbach A, Neubert TR. Does an additional structured information program during the intensive care unit stay reduce anxiety in ICU patients?: a multicenter randomized controlled trial. BMC Anesthesiol. 2014 Jun 28;14:48. doi: 10.1186/1471-2253-14-48. eCollection 2014.

    PMID: 25071414DERIVED

  • Fleischer S, Berg A, Neubert TR, Koller M, Behrens J, Becker R, Horbach A, Radke J, Rothmund M, Kuss O. Structured information during the ICU stay to reduce anxiety: study protocol of a multicenter randomized controlled trial. Trials. 2009 Sep 14;10:84. doi: 10.1186/1745-6215-10-84.

    PMID: 19751500DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 1, 2008

First Posted

October 2, 2008

Study Start

January 1, 2008

Primary Completion

December 1, 2009

Study Completion

March 1, 2010

Last Updated

June 3, 2010

Record last verified: 2010-01

Locations

DE(3)