Cavender 2004.

Study characteristics
Methods	RCT. 2 arms.
Participants	Number of children: 23 control, 20 treatment Sex of children: 19 M, 24 F Age range of children: 4 ‐ 11years Mean age of children: 7.88 ± 1.74 years Needle procedure: venepuncture or IV insertion Diagnosis of child: surgical (n = 11), trauma (n = 7), vomiting (n = 9), other (n = 16) Inclusion criteria: 4 ‐ 11 years old, English‐speaking, has medical order for venepuncture or IV insertion Exclusion criteria: children with chronic illness, children presenting with possible child abuse Setting: emergency department of private 322‐bed, pediatric medical center in the Southwestern USA
Interventions	1. Distraction + parental positioning: Standard care with the addition of instructions from child life specialists on positioning and distraction. Parents engaged their child with the distraction by asking questions and reminding them to concentrate 2. Standard care control
Outcomes	Pain measure: Child self‐report during procedure: Wong Baker FACES Pain Rating Distress measure: Child self‐report during procedure: Glasses Fear Scale Parent and Child Life Specialist report of child fear (during procedure, post‐procedure): Glasses Fear Scale Child Life Specialist report of child distress: Procedural Behavior Checklist (PBCL) Adverse events: none mentioned
Notes	Study dates: study dates not reported Funding: Les Femmes du Monde of Dallas, Texas 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 table of random numbers" p.36 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 outcome assessment
Incomplete outcome data (attrition bias) All outcomes	Low risk	No missing data
Selective reporting (reporting bias)	High risk	One or more outcomes of interest are reported incompletely
Other bias	Unclear risk	Insufficient information to assess whether an important risk of bias exists (e.g. reliability of fear scale)