The goal of this trial is to evaluate the effect of standardized oral, written and audiovisual information, given in the emergency department, on the development and severity of post traumatic symptoms in patients with mild traumatic brain injury…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Posttraumatische klachten na LTH
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Presence of post traumatic symptoms, as measured with th Riversmead Post
Concussion Questionnaire, 1 week and 3 months after MTBI.
Secondary outcome
Return to work or other normal daily activities
Background summary
The Dutch Institute for Healthcare Improvement (CBO) guidelines, suggest that
providing MTBI patients with standardized written information in the early
phase in the emergency department, may positively influence the presence and
severity of post traumatic symptoms. However, there is a pausity of evidence
supporting this suggestion.
Study objective
The goal of this trial is to evaluate the effect of standardized oral, written
and audiovisual information, given in the emergency department, on the
development and severity of post traumatic symptoms in patients with mild
traumatic brain injury after 1 week and 3 months.
Study design
Double-blind randomized controlled trial
Intervention
Patients will be informed and requested for their informed consent. If
included, patients will be assigned to either an intervention or a control
group. Both groups will be provided with standardized basic information about
their treatment and follow-up. The intervention group will receive additional
extensive written and audiovisual information, containing background
information on MTBI and suggestions on possible coping strategies for post
traumatic complaints.
Study burden and risks
Included patients will have a longer stay of about 10-15 minutes on the
emergency department, due to logistical factors and the fact that they will
receive extra information from their treating physician. Further, patients
agree to be contacted by phone twice, for an interview of an estimated 20
minutes. There are no direct healthrisks associated with the participation of
this study. Patients receiving the additional information in the intervention
group, could possibly benefit from the positive effect on their post-traumatic
symptoms.
Leyweg 275
Den Haag 2545 CH
NL
Leyweg 275
Den Haag 2545 CH
NL
Listed location countries
Age
Inclusion criteria
Aldult patients with mild traumatic brain injury (MTBI) admitted to the emergency department (ED)
Exclusion criteria
Not able to speak or write Dutch
Suffering from mental retardation or dementia
Abnormal head CT
Neurological impairment
Design
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL43651.098.13 |