Gonzalez 1993.

Study characteristics
Methods	RCT. 3 arms.
Participants	Number of children: 14 control, 14 treatment Sex of children: 21 M, 21 F Age range of children: 3 ‐ 7 years Mean age of children: 4.9 ± 1.2 years (intervention); 4.6 ±.8 years (control) Needle procedure: Immunization Diagnosis of child: none Inclusion criteria: none given Exclusion criteria: none given Setting: primary care clinic at a large, urban public hospital in the United States
Interventions	1. Distraction: Prior to the procedure, mothers were instructed how to verbally distract their child during the medical procedure with modeling (through recording) and practice of example distractions. During the procedure, a large sign with distraction examples and a research assistant were available to cue parents. 2. No treatment control: Mothers listened to a short lecture and discussed transportation to the hospital. 3. Reassurance: Mothers taught and practised reassuring their child verbally during the medical procedure.
Outcomes	Pain measure: Child self‐report: Oucher Pain Rating Scale Distress measure: OSBD‐R Modified Frankl Behavior Rating Scale Adverse events: None mentioned
Notes	We used a total N of 28 for this study (instead of 42) because we only included 2 of 3 intervention (Distraction versus Control). This is because there is already considerable existing research to suggest that reassurance is a distress‐promoting strategy, and was therefore not included as one of the interventions assessed in this review. 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 ‐ using a block randomization procedure that took age into account ‐ 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	Unclear risk	Insufficient information to permit judgment of 'low' or 'high' risk
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Insufficient information to permit judgment of 'low' or 'high' risk (e.g. research assistant ratings)
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	Unclear risk	Insufficient information to assess whether an important risk of bias exists