Modified Environment for Agitation in Patients With TBI

Modified Environment for Agitation in Patients With Traumatic Brain Injury: a Controlled Multicenter

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02524067

Acronym

ABS

Enrollment

Registered

2015-08-14

Start date

2015-09-30

Completion date

2018-05-31

Last updated

2018-05-11

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

Conditions

Agitated Behaviour, Traumatic Brain Injury (TBI)

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.

Interventions

BEHAVIORALMultifactorial circadian concept

Circadian light, systematic information, music, individual foreclosure

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Patients with psychiatric diagnose and not speaking danish -

Design outcomes

Primary

Measure	Time frame
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

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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026