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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00189046
Other study ID # 03/237-E
Secondary ID
Status Terminated
Phase Phase 4
First received September 12, 2005
Last updated September 12, 2005
Start date January 2004
Est. completion date April 2005

Study information

Verified date December 2004
Source UMC Utrecht
Contact n/a
Is FDA regulated No
Health authority Netherlands: Medical Ethics Review Committee (METC)
Study type Observational

Clinical Trial Summary

It has been suggested that cognitive functioning is impaired in chronic pain patients. Since most of these pain patients engage in daily activities including driving, it was hypothezised that they may have an increased risk of becoming involved in traffic accidents.


Description:

Most chronic pain patients engage in daily activities including driving. Driving a car is a complex task requiring mental alertness and a variety of cognitive functions such as perception, attention, learning, memory and decision making.Several studies have demonstrated cognitive impairments on laboratory tasks in patients with chronic pain, particularly on measures assessing attentional capacity, processing speed and psychomotor speed. These findings suggest that car driving performance might be impaired, and that chronic pain patients may therefore have an increased traffic accident risk. Unfortunately, no studies have investigated the impact of chronic pain on actual driving ability. The present study was designed to investigate the effects of chronic pain on actual driving performance during normal traffic. In addition to the on-the-road driving test, psychomotor, and memory tests measuring driving-related skills were conducted in the laboratory. Moreover, effects of pain on an attentional capacity test were tested using event-related potentials.


Recruitment information / eligibility

Status Terminated
Enrollment 30
Est. completion date April 2005
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 30 Years to 60 Years
Eligibility Inclusion Criteria:

age driving licence driving experience normal vision right-handed fluently Dutch speaking

Exclusion Criteria:

psychological or physical disorder drug or alcohol abuse psychotropic medication use excessive smoking, drinking

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Intervention

Behavioral:
driving and laboratory tests


Locations

Country Name City State
Netherlands Department of Psychopharmacology Utrecht

Sponsors (2)

Lead Sponsor Collaborator
UMC Utrecht Utrecht University

Country where clinical trial is conducted

Netherlands, 

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