A study protocol for a single-centred randomized trial to investigate the effect of pre-treatment communication methods on dental anxiety among adult dental patients

OBJECTIVE: Optimal oral health is an essential component of good quality of life. However, this may be hindered by dental anxiety (DA), thereby, affecting the utilization of dental services. DA could be alleviated by pre-treatment information; however, the method of delivering this information is yet to be explored. It is, therefore, necessary to assess the modes of presenting pre-treatment information to ascertain the one with significant effect on DA. This will improve treatment outcomes and quality of life for individuals. Hence, the primary objective is to assess the effect of audiovisual and written forms of pre-treatment information on DA, while the secondary objective will compare the subjective and objective methods of assessing DA with psychometric anxiety scale (Index of Dental Anxiety and Fear (IDAF)-4C(+)) and salivary alpha-amylase respectively. STUDY DESIGN: Single-centred, single-blind, parallel-group, four-arm randomized clinical trial. METHODS: The study will compare the effects of audiovisual and written forms of pre-treatment information on DA among adults. Patients 18 years and above scheduled for dental treatment will be screened for eligibility. Written informed consent will be sought before participation. Participants will be allocated randomly using block randomization, to the groups; G1: audiovisual and G2: a written form of pre-treatment information. At the visit, participants will complete the DA questionnaires (IDAF-4C(+), Modified Dental Anxiety Scale and Visual Analogue Scale). Physiological anxiety-related changes of salivary alpha-amylase will be measured using a point-of-care kit (iPro oral fluid collector) at baseline, and 10 min after intervention. Furthermore, blood pressure will be taken at baseline and 20 min into the treatment. The mean changes of physiologic anxiety levels and 95% confidence intervals will be compared between the methods of pre-treatment information. DISCUSSION: This study hopes to establish pre-treatment information as a method for reducing DA among the populace. Also, to assess the relationship between questionnaire-based and physiologic methods of assessing DA.