The goal of the study is to investigate psychoneurobiological mechanisms of persistent itch in patients following burn injury.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Patienten met brandwondenletsel, minimaal 6 maanden na incident.
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
This is an explorative study, investigating four different aspects of the
psychoneurobiological processing of itch in patients with burn wounds and
healthy controls. Since each of the four psychoneurobiological characteristics
is individually relevant, the study has four different outcome measures:
1. For the sensory characteristics, visual analogue scale (VAS) scores for itch
will be used as primary endpoint for the measurements for itch sensitivity as
well as for the central modulation of itch (change in VAS itch).
2. For the neurobiological characteristics, individual alpha-power and peak
frequency during resting state EEG as well as in response to itch stimuli
(event-related EEG) will be used.
3. For the behavioral characteristics, the reaction time will be determined for
the implict tests.
4. For the cognitive-affective characteristics, the total score of validated
questionnaires will be used.
Secondary outcome
The secondary endpoint is to explore the autonomic heart rate responses in
response to the psychoneurobiological measurements.
Background summary
Itch is a common symptom of patients followings burns. The majority of patients
experience mild to severe levels of itch even 1-2 years following wound healing
after injury. Itch can severely affect the patient's well-being and daily
functioning. There is increasing evidence for altered perception and processing
of itch e.g., by sensitization processes, in patients with prolonged symptoms
of itch. However, these processes have hardly been studied in patients with
burn injury. Knowledge on the mechanisms underlying itch may contribute to
early identification of patients at risk to develop persistent itch and the
early treatment of itch symptoms in burn-injured patients.
Study objective
The goal of the study is to investigate psychoneurobiological mechanisms of
persistent itch in patients following burn injury.
Study design
In this experimental study, psychoneurobiological mechanisms of itch in
patients with persistent itch following burn injury and healthy subjects will
be investigated on four different levels of itch perception and processing,
i.e., sensory, neurobiological, behavioral, and cognitive-affective
characteristics. To this end, validated and frequently applied methods of
quantitative sensory testing (QST), electroencephalography (EEG), implicit
tests for measuring automatic behavioral responses to itch, and questionnaires
measuring cognitive-affective responses to itch will be used.
This study contributes to our knowledge on the psychoneurobiological mechanisms
of itch in burn patients. In line with what is known on the
psychoneurobiological processing of itch in patients with persistent itch
resulting from skin disease, it is expected that the perception and processing
of itch in burn-injured patients might be comparably disturbed.
Study burden and risks
At home, participants first complete a series of validated questionnaires
measuring cognitive-affective aspects related to burn wounds, itch or physical
symptoms in general (duration ca. 30-45 minutes). Participants will then visit
the Radboud University Nijmegen (Medical Centre) once for approximately four
hours, including breaks. Non-invasive EEG measurements will be conducted in
resting state, and in response to different quantitative sensory testing (QST)
stimuli evoking short-term itch (and/or pain). QST stimuli have frequently been
applied in our research group and have been shown to be evoke mild to moderate
VAS scores in healthy subjects and patients (e.g., van Laarhoven et al.,
2007;2010a, 2010b;2012;2013). QST stimuli also enable the assessment of central
itch modulation (van Laarhoven et al., Pain 2010). Simple computer tasks will
be applied to measure automatic responses to itch, e.g., the approach-avoidance
task (AAT), which have previously been applied within our research group in
other patient groups with itch, who experienced the task as not-burdensome.
Non-invasive measurements for heart rate will also be conducted. No risks are
involved with participation in this study.
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
Age >= 18 years.
Itch symptoms up to at least 6 months after burn injury (for patients with burn wounds only)
Exclusion criteria
1. Severe physical or psychological morbidity that would adversely affect participation (e.g., heart- or lung disease or DSM-IV diagnoses).
2. Use of pacemaker.
3. Pregnancy.
4. Burn wounds affecting the head (due to EEG measurements).
5. Chronic pain or itch symptoms with medical cause other than burn wounds.
Design
Recruitment
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 | NL43955.091.13 |