Kleiber 2001.

Study characteristics
Methods	RCT. 2 arms.
Participants	Number of children: 22 control, 22 treatment Sex of children: 11 M, 33 F Age range of children: 4 ‐ 7 years Mean age of children: 62.8 ± 16.7 months (intervention); 59.4 ± 11.7 months (control) Needle procedure: IV Insertion Diagnosis of child: being treated or evaluated for non‐life‐threatening conditions such as chronic urinary tract infections, urinary incontinence, chronic constipation, growth failure, reactive airway disease Inclusion criteria: no neurological or sensory impairment at IV site, child able to distinguish between biggest and smallest in order to complete Oucher Pain scale, parent with legal custody agreed to be with child during procedure, parent able to speak and read English Exclusion criteria: none reported Setting: large Midwestern tertiary care hospital in the United States
Interventions	1. Parent coaching and distraction: Parents viewed an educational video on distraction that provided rationale, suggestions, and modeling of effective distraction with children. Children remained with their parents during the video and were involved in selecting a distracter with their parents. 2. Standard care control: Individual practitioners determined use of EMLA and parents were allowed to accompany their child during the procedure.
Outcomes	Pain measure: Child self‐report: Oucher Pain Rating Scale Distress measure: Parent report: Perception of Procedures Questionnaire‐Revised (PPQ‐R) Behavioral: OSBD‐R Adverse events: none mentioned
Notes	Although not stated in the paper, personal communication with the author confirmed randomization was achieved via a random table of numbers. Study dates: study dates not reported Funding: NIH‐NINR predoctoral award #F31 NR07107‐01, and National Research Service Award #T32‐NR07082‐02 Conflicts of interest: none declared
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Randomized ‐ permutated block randomization used to assure that a balanced number of children with histories of high distress were randomized to the control and experimental groups. 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	Study participants were not blinded
Blinding of outcome assessment (detection bias) All outcomes	High risk	No blinding of self‐report and parent‐report of outcome assessment
Incomplete outcome data (attrition bias) All outcomes	Low risk	Reasons for missing data unlikely to be related to true outcome and balanced across intervention groups
Selective reporting (reporting bias)	High risk	One or more outcomes of interest are reported incompletely
Other bias	High risk	Multiple potential sources of bias related to study design and other problems (e.g. low reliability of parent outcome measure)