ISRCTN ISRCTN43755461
DOI https://doi.org/10.1186/ISRCTN43755461
Secondary identifying numbers NTR475
Submission date
27/01/2006
Registration date
27/01/2006
Last edited
26/08/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Judith Versloot
Scientific

Academisch Centrum Tandheelkunde Amsterdam (ACTA)
Louwesweg 1
Amsterdam
1066 EA
Netherlands

Phone +31 (0)20 5188243
Email j.versloot@acta.nl

Study information

Study designRandomised open label active controlled parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Scientific titleComputerized anaesthesia delivery system (Wand) versus traditional syringe: comparing pain and pain-related behaviour in children
Study acronymWAND
Study objectivesDoes the use of the Wand system reduce pain related behavior during the local anaesthesia injection in children?
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedAnesthesia injection, local
InterventionLocal anesthesia injection with a computerised anaesthesia delivery system (Wand) or the traditional syringe.
Intervention typeProcedure/Surgery
Primary outcome measureOccurrence of 5 pain related behaviors observed in 15 s intervals of the injection time.
Secondary outcome measuresVenham's Distress score (0-5) in 15 s intervals of the injection time and self-reported pain (0-10)
Overall study start date01/10/2005
Completion date01/06/2006

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit4 Years
Upper age limit11 Years
SexBoth
Target number of participants100
Key inclusion criteria1. Age 4-11 years
2. Needing two treatment sessions
3. Dutch speaking
Key exclusion criteriaSpecial education
Date of first enrolment01/10/2005
Date of final enrolment01/06/2006

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Academisch Centrum Tandheelkunde Amsterdam (ACTA)
Amsterdam
1066 EA
Netherlands

Sponsor information

Academic Centre Dentistry Amsterdam (ACTA) (Netherlands)
University/education

Louwesweg 1
Amsterdam
1066 EA
Netherlands

ROR logo "ROR" https://ror.org/04x5wnb75

Funders

Funder type

University/education

Interuniversity Dentistry Research School (IOT) (Netherlands)

No information available

Academic Centre Dentistry Amsterdam (ACTA) (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 12/07/2008 Yes No