Al‐Khotani 2016.

Methods	Study design: prospective randomised controlled trial, parallel Location: Saudi Arabia Number of centres: 1 Setting: university hospital Recruitment period: September 2007 to May 2008 Funding source: not discussed
Participants	Inclusion criteria: general good health, no previous dental experience involving LA administration for the last 2 years and restorative treatment required under LA Exclusion criteria: previous unpleasant experience in medical setting or known dental phobia as reported in the medical records, need for pharmacological management to co‐operate or medical disability such as the history of seizures or convulsion disorders, nystagmus, vertigo or equilibrium disorders, eye problems and autism Number of participants randomised: 56 Number of participants evaluated: 56 Number of males/females: 22 males, 34 females Mean age (years): Group 1: 8.3 (range 7 to 9.6), Group 2: 8.1 (range 7 to 9.8) Age range: 7 to 9 years old (mean: 8.2 +/‐ SD 0.8)
Interventions	Group 1: audiovisual distraction during treatment including delivery of LA Group 2 (control): conventional treatment, including delivery of LA
Outcomes	Anxiety: measured preoperatively and postoperatively using the Facial Image Scale (FIS). Self‐reported, 5 faces that best represent patient's emotional state, ranging from 1 to 5 Anxiety and co‐operation measured by Modified Venham's clinical ratings of anxiety and co‐operative behaviour scale (MVARS). This scale has 6 categories ranging from 0 to 5 Anxiety measuring blood pressure (systolic and diastolic) and pulse rate. Measurements made at: intraoral examination, injection with LA, application of rubber dam, cavity preparation, and tooth restoration
Notes	CONSORT flow chart not presented Declarations of interest: the authors declare no conflicts of interest Sample size calculation made and discussed however, no reference to previous papers or pilot studies for information Consent form and ethical approval obtained Study performed by the same paediatric dentist Pilot study performed with 6 patients that were not included in the study Trained, independent assessors. Interexaminers reliability obtained (Cohen's kappa: 0.85)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	Quote: "The randomization was performed by a dental assistant not participating in the study by assigning the first patient to either group by the toss of a coin, after that the next patient went to the other group" Comment: method described implies that the first patient was assigned randomly, but that every patient after that was assigned via alternation
Allocation concealment (selection bias)	Unclear risk	No discussion regarding allocation concealment is presented
Blinding of participants and personnel (performance bias) All outcomes	High risk	Children not blinded. No discussion regarding blinding of personnel Quote: "... in the AV‐group, before the start of the restorative procedure, the child was introduced to the AV‐system (i‐theatreTM) and allowed to choose his/her favourite cartoon…"
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No discussion on how blinding of observers was carried out. No discussion whether children in the control group were wearing AV glasses or similar in order to blind raters Quote: "The two observers were blinded, and the tapes were coded during the main study"
Incomplete outcome data (attrition bias) All outcomes	High risk	Numbers of patients not presented on tables or discussed in text. No CONSORT flow chart therefore no information on number of dropouts and reasons for them
Selective reporting (reporting bias)	Unclear risk	Descriptive statistics on number of patients not presented
Other bias	Low risk	No further bias identified