Cohen 2015.

Study characteristics
Methods	RCT. 3 arms.
Participants	Number of children: 30 control, 30 parenting training plus distraction, 30 distraction Sex of children: 44 M, 46 F Age range of children: 4 ‐ 6½ years Mean age range of children: 4.8 years ± 9.7 months Needle procedure: routine vaccinations Diagnosis of child: none reported Inclusion criteria: 4 ‐ 6 years, presenting for preschool immunizations Exclusion criteria: non‐English speakers unable to complete measures, child having significant medical or developmental issues Setting: outpatient pediatric practice in the United States
Interventions	1. Bear Essentials parent training plus distraction: Parents received a laptop loaded with the “Bear Essentials” program to complete while in the waiting room. This is an interactive computer program with a narrator that explains parent behaviors that positively or negatively impact child distress during an immunization. In the treatment room, the nurse provided a portable DVD player and a selection of movies to the family to use during the procedure. 2. Distraction only: Parents were provided with a laptop installed with parent‐led computer games to use while in the waiting room. In the treatment room, the nurse made available a portable DVD player and a selection of movies to watch during the procedure. No direct training about optimal behavior was provided to the parents. 3. Standard care control: Parents were provided treatment as usual. No training, movies, or other systematic distractions were provided.
Outcomes	Pain measure: Child self‐report: Faces Pain Scale‐Revised (FPS‐R) Parent report of child pain: VAS (100 mm) Nurse report of child pain: VAS (100 mm) Distress measure: Child procedural behaviors of crying, screaming, and negative emoting Adverse events: none mentioned
Notes	Study dates: Study dates not reported Funding: grant from the National Institute of Child Health and Human Development at the National Institutes of Health (1R21HD047263‐01) Conflicts of interest: none declared
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "computer generated random number table" p.3
Allocation concealment (selection bias)	High risk	Quote: "condition assignment remained concealed in a binder"
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)	Unclear risk	Insufficient information to permit judgment of 'low' or 'high' risk
Other bias	Low risk	Appears to be free of other bias that would affect outcomes.