Structured Information During the Intensive Care Unit Stay

A Randomized Controlled Multi Center Study to Evaluate the Efficacy of a Structured Information Program During ICU Stay

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00764933

Enrollment

211

Registered

2008-10-02

Start date

2008-01-31

Completion date

2010-03-31

Last updated

2010-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety

Keywords

information programme, anxiety reduction, multicenter trial, intensive care, critical care

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.

Detailed description

The trial is designed as a prospective multicenter randomized controlled trial including an intervention and a control group. The control group receives an unspecific conversation. The intervention group receives a standardized information program with specific procedural, sensory and coping information about the ICU. Anxiety will be measured with a VAS during ICU stay and with a questionnaire after ICU discharge.

Interventions

BEHAVIORALStructured 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.

OTHERUnspecific 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Patient self-reported anxiety	First three days on ICU and/or within 24 hours after ICU discharge

Secondary

Measure	Time frame
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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026