Modified Environment for Agitation in Patients With TBI

Not Applicable

Completed

• Conditions: Traumatic Brain Injury (TBI); Agitated Behaviour
• Interventions: Behavioral: Multifactorial circadian concept

• Registration Number: NCT02524067
• Lead Sponsor: University of Aarhus

Brief Summary

This study examines the effect of an intervention consisting of dynamic circadian light and sound therapy, as well as systematic information on sleep pattern, agitated behavior and functioning level.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-07-08
• Study First Submitted QC: 2015-08-12
• Study First Posted: 2015-08-14
• Study Start: 2015-09
• Status Verified: 2016-09
• Primary Completion: 2018-05
• Study Completion: 2018-05
• Last Update Submitted: 2018-05-04
• Last Update Posted: 2018-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients with moderate and severe Traumatic Brain Injury (TBI)
• Diagnosed with Glasgow Coma Score (GCS) lower than 13-

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Exclusion Criteria

• Patients with psychiatric diagnose and not speaking danish -

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Multifactorial circadian concept	Intervention: Circadian lighting, systematic information, music, foreclosure of the individual patient

Primary Outcome Measures

Name	Time	Method
Agitation on Agitated Behaviour Scale (ABS)	One year
Functional abilities on the Early Functional Abilities Scale (EFA)	One year
Functional abilities on the Glasgow Outcome Extend Scale	12 month after admission

Secondary Outcome Measures

Name	Time	Method
Orientation and duration of post-traumatic amnesia on the Galveston Orientation and Amnesia Scale (GOAT)	One year

Trial Locations

Locations (1)

Leanne Langhorn; 🇩🇰 Aarhus, Region Midt, Denmark