Balan 2009.

Study characteristics
Methods	RCT. 3 arms.
Participants	Number of children: 50 control, 50 treatment Sex of children: 55 M, 45 F Age range of children: 5 ‐ 12 years Mean age of children: 7.96 ± 2.18 years Needle procedure: venepuncture for blood collection Diagnosis of child: heterogeneous (see exclusion criteria). Inclusion criteria: 5 ‐ 12 years old, requiring venepuncture for blood collection Exclusion criteria: history of hypersensitivity to local anesthetics of the amide type or to 1 or more of the constituents of EMLA, history of congenital or idiopathic methaemoglobinaemia, glucose‐6‐phosphatase deficiency or sever hepatic disease, children with altered sensorium, children whose clinical condition warranted the urgent administration of drugs Setting: inpatient department at a hospital in Mumbai, India
Interventions	1. Music therapy: Indian classical instrumental music using headphones 2. No intervention control: placebo cream and headphones with no music 3. EMLA cream
Outcomes	Pain measures (all ratings at minute 0): Child self‐report: 0 ‐ 10 VAS Caregiver/parent report of child pain: 0 ‐ 10 VAS Nurse/health professional report of child pain: 0 ‐ 10 VAS Independent observer report of child pain: 0 ‐ 10 VAS Adverse events: none mentioned
Notes	We used a total N of 100 for this study (instead of 150) because we only assessed 2 of 3 interventions (music therapy versus no intervention control group). Study dates: study dates not reported Funding source: none stated Conflicts of interest: none declared
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "randomized…using random number table" p.470 Par 1
Allocation concealment (selection bias)	High risk	Use of an open random allocation schedule (e.g. random‐number table)
Blinding of participants and personnel (performance bias) All outcomes	High risk	Participants and personnel were not blinded
Blinding of outcome assessment (detection bias) All outcomes	High risk	No blinding of self‐report outcome assessment and researcher provided intervention and outcome assessment
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Quote: "Whenever possible this child was also told to indicate his or her score on the VAS." p. 470 Par 2
Selective reporting (reporting bias)	High risk	One or more outcomes reported incompletely for inclusion in meta‐analysis
Other bias	Low risk	Appears to be free of other bias that would affect outcomes