A single-centre investigator-blinded randomised parallel-group study protocol to investigate the influence of an acclimatisation appointment on children’s behaviour during N2O/O2 sedation as measured by psychological, behavioural and real-time physiological parameters

Abstract Aims and objectives To describe a study protocol of a randomised control trial (RCT) assessing the effectiveness, in reducing dental anxiety, of an acclimatising nitrous oxide sedation (N2O) session prior to actual dental treatment with N2O. Materials and methods A single-centre investigator-blinded parallel-group RCT conducted in a postgraduate dental hospital in Dubai, United Arab Emirates (UAE). Anxious children requiring N2O (aged 5–15 years) will be randomly assigned to; a study group: children who will have a preparatory N2O trial experience or; a control group: children who will only have N2O explained to them. Treatment with N2O for both groups will start at the second visit. The following outcomes will be recorded: completion of dental treatment, anxiety scores at baseline and after treatment (using the Modified Child Dental Anxiety Scale faces), behaviour of the child (using Frankl Rating Behaviour Scale) and the acquisition of real-time physiological anxiety-related parameters (using E4®electronic wrist devices). Results The data will be analysed statistically. Discussion There is a paucity of research regarding dental N2O acclimatising appointments. This RCT will supplement existing literature. Conclusions This RCT will report whether prior acclimatising of a child to N2O sedation is effective, or not, in improving dental treatment behaviour.