Structured Information During the Intensive Care Unit Stay

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

211 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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1

Structured information

Group Type EXPERIMENTAL

Structured information

Intervention Type BEHAVIORAL

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.

2

Unspecific conversation

Group Type SHAM_COMPARATOR

Unspecific conversation

Intervention Type OTHER

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.

Interventions

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