Vosoghi 2010.

Study characteristics
Methods	RCT. 2 arms.
Participants	Number of children: 36 treatment, 36 control Sex of children: 37 M, 35 F Age range of children: 3 ‐ 6 years old Mean age range of children: not reported Needle procedure: IV insertion Diagnosis of child: infectious diseases (57), internal medicine diseases (15) Inclusion criteria: 3 ‐ 6 years, orientation to time, place and people, ability to make verbal communication Exclusion: pain, seizure, or any life‐threatening condition, administration of pain killers, insertion of > 1 catheter, time of attempting to insert the catheter > 60 seconds Setting: emergency department of a children’s hospital in Iran
Interventions	1. Distraction: 2 minutes before the IV insertion, distraction was done using a bubble maker (i.e. a train that whistles and makes bubbles while moving) and was continued until the end of the procedure. 2. Control: Same overall study procedure for all participants. No distraction was administered.
Outcomes	Pain measure: Child self‐report: OUCHER Physiological measure: Heart rate Oxygen saturation Adverse events: none mentioned
Notes	This was an article in Farsi and we had a translator help us with data extraction. For study exclusion criteria, the authors did not explain what they meant by 'pain' but presumably this was pain not explicitly due to the needle procedure. In addition, although means and SDs for the OUCHER were not reported in the paper, we obtained them through a contact with the study authors. Study dates: study dates not reported Funding: none stated Conflicts of interest: none declared
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Randomized ‐ no further details. Insufficient information to permit judgment of 'low' or 'high' risk
Allocation concealment (selection bias)	Unclear risk	Insufficient information to permit judgment of 'low' or 'high' risk
Blinding of participants and personnel (performance bias) All outcomes	High risk	No mention of blinding but nature of psychological intervention precludes this
Blinding of outcome assessment (detection bias) All outcomes	High risk	No blinding of outcome assessment
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Insufficient reporting of exclusions to permit judgment of 'low' or 'high' risk
Selective reporting (reporting bias)	High risk	One or more outcomes of interest are reported incompletely to include in meta‐analyses
Other bias	Unclear risk	Insufficient information to assess whether an important risk of bias exists