Rimon 2016.

Study characteristics
Methods	RCT. 2 arms.
Participants	Number of children: 24 control, 29 treatment Sex of children: 21 M, 32 F Age range of children: 2 ‐ 15 years Mean age range of children: 6.9 ± 3.4 years (control); 5.6 ± 2.8 years (treatment) Needle procedure: blood draw or IV access Diagnosis of child: none reported Inclusion criteria: accompanied by a parent Exclusion criteria: if they needed urgent IV cannulation, had developmental disabilities, were critically ill or needed IV cannulation for the treatment of a severe bacterial infection, or if they had received glucocorticoids during the preceding 6 weeks Setting: pediatric emergency department in Israel
Interventions	1. Medical clown: Children spent 15 minutes with the medical clown before the procedure, followed by blood collection in the presence of the medical clown. The medical clown used CBT, including distraction through humour (magic tricks, puppets, jokes) and imagery (imagining a pleasant object). 2. No medical clown: Parents were not given any instructions in how to help their child, nor did emergency department nurses use any guided imagery or distraction techniques, even though many were knowledgeable about distraction techniques.
Outcomes	Pain measure: Child self‐report (4 ‐ 7 year olds): FPS‐R Child self‐report (7+ years): ViAS (100 mm VAS) Physiological measure: Serum cortisol plasma levels Adverse events: none mentioned
Notes	Study dates: 1‐year period ending in September 2015. Funding: The Magi Foundation and The Adelis Foundation Conflicts of interest: none declared
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "randomly assigned...by a patient allocation scheme implementing a stratified block design. Block size varied randomly from four to eight" (p. 681)
Allocation concealment (selection bias)	Unclear risk	Unclear if all appropriate safeguards taken with assignment envelopes (i.e. opaque)
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	Missing data minor and deemed unlikely to influence study outcomes
Selective reporting (reporting bias)	Unclear risk	Unclear reporting of pain outcomes for 2 ‐ 3‐year‐olds.
Other bias	Low risk	Appears to be free of other bias that would affect outcomes