Miller 2016.

Study characteristics
Methods	RCT. 5 arms.
Participants	Number of children: 20 control, 19 or 20 per treatment arm Sex of children: 48 M, 50 F Age range of children: 3 ‐ 12 years Mean age range of children: 6.73 ± 2.71 years Needle procedure: IV cannulation Diagnosis of child: mixed (34% trauma, 27% gastrointestinal, 39% generic medical conditions) Inclusion criteria: 3 ‐ 12 years, required an IV cannulation procedure Exclusion criteria: unconscious or required high‐level medical care, had cognitive difficulties impacting use of self‐reported outcome measures, had uncorrected visual impairment impacting the effective use of interventions, were non‐English‐speaking Setting: emergency department at the Royal Children's Hospital, Brisbane, Australia
Interventions	1. Ditto distraction: Children had access to interactive games and stories on a Ditto device during the procedure. The distraction stories and games use multisensory stimuli including animated visual content, sound, and vibration to divert a child's attention away from painful and distressing medical procedures. 2. Ditto procedural preparation: Children had access to an interactive procedural preparation story on a Ditto device before the procedure. The story informs the child about the steps in the upcoming procedure and what the child can do to help staff during the procedure. 3. Ditto combined procedural preparation and distraction: Children had access to a Ditto device for both the procedural preparation story before the procedure and interactive stories and games as distraction during the procedure. 4. PlayStation portable: Children had access to a Sony handheld PlayStation Portable and interactive games during the procedure. 5. Standard distraction (‘Usual Care’): Children had access to toys, nursing, and caregiver interaction as in standard protocol.
Outcomes	Pain measures: Child self‐report: Wong Baker FACES scale (during procedure) Caregiver/parent report of child pain: VAS (during procedure) Faces, Legs, Activity, Crying, Consolability (FLACC): (during procedure) Adverse events: none mentioned
Notes	Study dates: March 2011 to July 2012 Funding: none stated Conflicts of interest: none declared
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "block randomization". Insufficient information to permit judgment of 'low' or 'high' risk.
Allocation concealment (selection bias)	Low risk	Quote: "use of consecutively‐numbered sealed opaque envelopes" (p. 446)
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 outcome assessment
Incomplete outcome data (attrition bias) All outcomes	Low risk	No missing data
Selective reporting (reporting bias)	Unclear risk	Insufficient information to permit judgment of 'low' or 'high' risk
Other bias	Low risk	Appears to be free of other bias that would affect outcomes