Primary Objective: Analyse the behavioural response of individuals with Down's syndrome directly after a painful dental stimulus and compare this with video-analysed behaviour.Secondary Objective(s): 1) Determine which observational scale can…
ID
Source
Brief title
Condition
- Other condition
- Chromosomal abnormalities, gene alterations and gene variants
Synonym
Health condition
Downsyndroom
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The participants will all have a different mental level. Which will probably
mean the will all react in a different way.
The primary study outcomes are the pain-scores of the dentist, the dental
assistant and the patient.
Secondary outcome
The pain behaviour will be assessed using different observation scales:
1) 3 behaviours form the Facial Action Coding system
2) Non-communicating Pain Checklist for adults
3) Numeric pain scale
4) Comfort scale
Background summary
A lack of research has limited our understanding of the prevalence and
experience of pain and its longterm implications for individuals with
developmental disabilities. Little research is done to discribe the way in
which individuals with Down's syndrome express and communicate pain.The dental
setting provides the opportunity to observe these individuals during a
potentially painful dental stimulus.
Study objective
Primary Objective:
Analyse the behavioural response of individuals with Down's syndrome directly
after a painful dental stimulus and compare this with video-analysed behaviour.
Secondary Objective(s):
1) Determine which observational scale can be used to reliably and accurately
assess pain during a dental treatment with individuals with Down's syndrome.
2) Determine the inter-analyst reliability of the two independent analysts who
analyse the video's.
3) Compare the response of individuals with Down's syndrome on a aversive
dental treatment with the response on a painful dental treatment (anaesthesia
injection or mechanical removal of calculus) to indicate behavioural
expression related to pain.
Study design
The participants will be videotaped during their dental treatment. These
video's will be assessed using different pain-observation scales to assess the
painbehaviour of the participants.
Directly after the potential painful stimulus (dental injection) the
participants will be asked how much pain they had. Furthermore, the dentist and
the dental assistent will give a score on how much pain they thought the
participant felt.
Afterwards, the scores of the different observation scales will be compared
with each other and with the scores given by the clinicians. Also the
inter-rater reliability will be assessed and the validity of the different
scales by comparing the scores of a painful with a non-pain stimulus.
Study burden and risks
Not applicable
Louwesweg 1 (ACTA)
Amsterdam 1066EA
NL
Louwesweg 1 (ACTA)
Amsterdam 1066EA
NL
Listed location countries
Age
Inclusion criteria
Individuals 18 years or older with Down's syndrome.
Exclusion criteria
Indivuduals with Down's syndrome younger than 18 years.
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 | NL28326.075.10 |