Primary: Is Skin Conductance a valid and reliable pain assessment tool for postoperative and procedural pain in neonates and infants < 3 yr? Secondary: 1. The effects of skin temperature, heart rate, respiration rate, blood pressure (dependent…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
pijn
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Skin conductance values, COMFORT behaviour scale
Secondary outcome
Parameters that may influence skin conductance
- Skin temperature
- Respiratory rate
- Oxygen saturation
- Heart rate
- Bloodpressure (Systolic, diastolic, mean)
Background summary
The goal of our study is to compare pain assessment with the validated COMFORT
behavior scale with skin conductance measurements. We will perform this study
in preverbal children (<3 years old) at the intensive care unit or high care
unit of the Sophia Children*s Hospital. This group of patients will benefit
from a more objective way of pain assessment in postoperative care and
procedural pain. This study will be part of the validation process of skin
conductance as a pain assessment tool.
Study objective
Primary: Is Skin Conductance a valid and reliable pain assessment tool for
postoperative and procedural pain in neonates and infants < 3 yr?
Secondary:
1. The effects of skin temperature, heart rate, respiration rate, blood
pressure (dependent variables) on Skin Conductance values (primary outcome).
2. Sensitivity to change: Do Skin Conductance values significantly change after
analgesic treatment?
3. Sensitivity to change: Are Skin Conductance values significantly different
during a painful intervention versus a non-painful intervention?
Study design
A single centre, prospective, cross-sectional observational study
Study burden and risks
Risks to and burden for the patient are negligible. It is a non-intervention
study, so there will be no benefits for the patient by participating in the
study. The COMFORT behavior score is part of the standard care for children in
ErasmusMC - Sophia Children*s hospital. The validation of Skin Conductance as a
pain assessment tool can not be conducted without participation of the patients
in our study population.
Dr Molewaterplein 60
3015GJ Rotterdam
Nederland
Dr Molewaterplein 60
3015GJ Rotterdam
Nederland
Listed location countries
Age
Inclusion criteria
-Written informed consent of the parents
-Children under the age of three years
-(Planned) postoperative admission to the pediatric intensive care unit / high care.
Exclusion criteria
-Withdrawal of informed consent of the parents
-Skin conditions that may affect the skin conductance at the measurement site.
-Implanted pacemaker of implanted cardioverter defibrillator.
-Local or regional anesthesia, affecting the innervation of the measurement site.
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 | NL24509.078.08 |