Sinha 2006.

Study characteristics
Methods	RCT. 2 arms.
Participants	Number of children: 120 control, 120 treatment Sex of children: 120 M, 120 F Age range of children: 6 ‐ 18 years Mean age of children: 10.73 ± 3.5 years (intervention); 10.81 ± 3.9 years (control) Needle procedure: sutures for laceration repair Diagnosis: uncomplicated laceration repair involving only the skin and subcutaneous tissue, < 5 cm in length Inclusion criteria: 6 ‐ 18 years old, visiting ED for laceration repair between noon and midnight Exclusion criteria: children presenting with multiple lacerations greater than or equal to 1 complex laceration, or a laceration with other injuries Setting: hospital emergency department in a 253‐bed tertiary care children’s hospital serving a population of 2.5 million in a 17‐county service region in the United States
Interventions	1.Distraction: Children were given a choice of distracters including music, video games, or cartoon video. For children who did not show interest in any of these, a child life specialist read a book or blew bubbles during the procedure. Procedure was explained to the child. 2. Standard care control: Procedure was explained to the child.
Outcomes	Pain measure: Child self‐report: 7‐point FPS Anxiety/Distress measure: Child self‐report: State scale of State Trait Anxiety Inventory for Children (STAIC) Caregiver/parent report: 100 mm VAS Adverse events: none mentioned
Notes	SDs were not reported in the paper and we calculated them from available data. The STAIC outcome was only used with children 10 years and older. Study dates: October 2003 to August 2004 Funding: Ken Graff Young Investigator Grant award by the Section on Emergency Medicine, American Academy of Pediatrics Conflicts of interest: none declared
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Randomly assigned by a patient allocation scheme implementing a stratified block design to ensure equal gender. Insufficient information to permit judgment of 'low' or 'high' risk
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	Participants were not blinded
Blinding of outcome assessment (detection bias) All outcomes	High risk	No blinding of self‐report and parent‐report outcome assessment
Incomplete outcome data (attrition bias) All outcomes	Low risk	Reported missing data did not impact outcomes
Selective reporting (reporting bias)	Low 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. "heightened awareness of distraction techniques amongst ED personnel" p. 1167)