A single-centre investigator-blinded randomised parallel-group study protocol to investigate the influence of an acclimatisation appointment on children’s behaviour during N(2)O/O(2) sedation as measured by psychological, behavioural and real-time physiological parameters

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 (N(2)O) session prior to actual dental treatment with N(2)O. 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 N(2)O (aged 5–15 years) will be randomly assigned to; a study group: children who will have a preparatory N(2)O trial experience or; a control group: children who will only have N(2)O explained to them. Treatment with N(2)O 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 N(2)O acclimatising appointments. This RCT will supplement existing literature. CONCLUSIONS: This RCT will report whether prior acclimatising of a child to N(2)O sedation is effective, or not, in improving dental treatment behaviour.