Cassidy 2002.

Study characteristics
Methods	RCT. 2 arms.
Participants	Number of children: 33 control, 29 treatment Sex of children: 28 M, 34 F Age range of children: 5 years Mean age range of children: not reported Needle procedure: DPTP immunization Diagnosis of child: none Inclusion criteria: 5 years old, due to receive standard DPTP preschool immunization, in good health, developmentally normal, parent/guardian agreement to participate after initial recruitment contact Exclusion criteria: previously immunized with DPTP vaccine, previously hospitalized, the presence of any acute or chronic medical condition Setting: 2 urban pediatric practices in Halifax, Nova Scotia, Canada
Interventions	1. Audio‐visual distraction: Age‐appropriate TV musical cartoon 2. Blank screen standard care control: TV was present but off
Outcomes	Pain measure: Child self‐report: Faces Pain Scale (FPS) Experimenter rating of child pain: Children’s Hospital of Eastern Ontario Pain Scale (CHEOPS), from videotaped procedures Experimenter rating of child pain: Child Facial Coding System (CFCS) Distress measure: Parent rating of child anxiety: 10 cm VAS Adverse events: none mentioned
Notes	Study dates: study dates not reported Funding: Dalhousie Medical School Research Foundation Conflicts of interest: none declared
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "subjects were randomly assigned…using a standard randomization table" p.110 Par 2
Allocation concealment (selection bias)	High risk	Use of an open random allocation schedule (e.g. random‐number table)
Blinding of participants and personnel (performance bias) All outcomes	High risk	Study participants and personnel  were not blinded
Blinding of outcome assessment (detection bias) All outcomes	High risk	No blinding of self‐report outcome assessment
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	No reasons for missing data provided and unclear of potential impact on outcomes
Selective reporting (reporting bias)	Unclear risk	Insufficient information to permit judgment of 'low' or 'high' risk
Other bias	High risk	Multiple potential sources of bias related to study design and other problems (e.g. non‐neutral control stimulus)