Caprilli 2007.

Study characteristics
Methods	RCT. 2 arms.
Participants	Number of children: 54 control, 54 treatment Sex of children: 52 M, 56 F Age range of children: 4 ‐ 13 years Mean age range of children: 6.67 ± 3.19 (intervention); 7.07 ± 3.47 (control) Needle procedure: venepuncture Diagnosis of child: none given Inclusion criteria: native‐born, Italian‐speaking children Exclusion criteria: significant hearing or visual impairments, cognitive disorders, previous experience of hospitalization Setting: Anna Meyer Pediatric Hospital, Florence, Italy
Interventions	1. Music distraction: Live musicians played and sang music before, during, and after blood sampling. Parents were present and the child was invited to join in the music. Approximately 20 minutes. 2. Standard medical care control: Children in this group received standard medical care. The doctor and nurse who performed the procedure were the same for the control and the music groups, and they were instructed to maintain their normal modes of consolation and/or distraction.
Outcomes	Pain measure: Child self‐report: Wong Baker Faces Scale Distress measure: Amended form of Observational Scale of Behavioral Distress (OSBD‐A) (Phase 2 used in analyses) Adverse events: none mentioned
Notes	Study dates: November 2003 to February 2004 Funding: Anna Meyer Foundation Conflicts of interest: none declared
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: “children were randomly assigned to one of two 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 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	High risk	Had a potential source of bias related to the specific study design (e.g. timing of parent ratings)