Structured Information During the Intensive Care Unit Stay

Martin-Luther-Universität Halle-Wittenberg

Status: Completed

Conditions: Anxiety

Treatments: Behavioral: Structured information; Other: Unspecific conversation

Study type: Interventional

Funder types: Other

Identifiers

NCT00764933

PfVMS-T4

Details and patient eligibility

About

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.

Full 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.

Enrollment: 211 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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211 participants in 2 patient groups

1

Experimental group

Description:

Structured information

Treatment:

Behavioral: Structured information

2

Sham Comparator group

Description:

Unspecific conversation

Treatment:

Other: Unspecific conversation