To test the feasibility and added value of facial electromyography to continuous pain monitoring in infants
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
pijn 1) tijdens vaccinatie en 2) na chirurgische ingrepen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measures are the muscle activity of the corrugator
supercilii and the orbicularis oculii, either during a painful event or during
prolonged pain in infants at the NICU.
Secondary outcome
During the 1st part of the study only the Neonatal Facial Coding System.
During the 2nd part of the study the Neonatal Facial Coding System and the
movement of the extremities and heart rate.
Background summary
Pain in infants in clinical care is an undesirable emotion. The treatment of
pain is becoming an important part of the total treatment protocol. Recognition
of pain in infants is complicate because infants are not able to express pain
by speaking. Currently used pain assessments scales in infants are not feasible
for prolonged measurements in clinical care. Additionally, the used methods are
subjective. An objective and continuous pain assessment instrument is necessary
to optimise the treatment of pain. One of the major parameters in current pain
assessment tools is facial expression. Facial expression could be objectively
measured by facial muscle activity. Results of facial muscle activity
measurements are scarce and it is not yet clear whether it is possible to
measure facial muscular activity on neonates. Therefore facial muscle activity
will be the main outcome parameter in this study.
Study objective
To test the feasibility and added value of facial electromyography to
continuous pain monitoring in infants
Study design
Cross-sectional observation study
Study burden and risks
The burden and risks associated with participation are minimal. The subjects do
not undergo physical examinations or other tests; miniature sensors attached on
the skin with infant-friendly tape register only natural behaviours. Since the
objective of the study is pain monitoring in neonates, this study can only be
done using infants because pain expressions of adults or children who can speak
are not comparable to the expressions of infants.
s-Gravendijkwal 230
3015 CE Rotterdam
Nederland
s-Gravendijkwal 230
3015 CE Rotterdam
Nederland
Listed location countries
Age
Inclusion criteria
1st part of the study:
- the neonate/baby has a gestational age of at least 36 weeks.
2nd part of the study:
- Neonates and infants aged 0-18 months
- Weight > 1500 grams
- Abdominal, including urological, or thoracic surgery
Exclusion criteria
1st part of study:
- exclusion criteria for a vaccination will be followed.
2nd part of the study:
- Receiving sedative drugs or muscle relaxants < 12 hours prior to surgery
- Receiving sedative drugs or muscle relaxants after surgery
- Neurological damage (posthypoxic encephalopathy or major congenital anomalies of the central nervous system)
- (Severe) spasticity
- Hypotonia
- Corrected gestational age < 36 weeks
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 | NL13073.078.06 |