Yinger 2016.

Study characteristics
Methods	RCT. 2 arms.
Participants	Number of children: 29 control, 29 treatment Sex of children: 27 M, 31 F Age range of children: 4 ‐ 6 years Mean age of children: 56.6 ± 6.7 months Needle procedure: immunizations Diagnosis: none reported Inclusion criteria: 48 ‐ 72 months of age, accompanied by at least 1 English‐speaking parent or legal guardian, and scheduled to receive at least 1 immunization by injection during their doctor visit Exclusion criteria: none reported Setting: 3 healthcare sites in the southeastern USA (2 family medicine clinics; 1 hospital‐affiliated pediatric practice)
Interventions	1. Music therapy: The music therapy intervention included different songs and CBTs within each phase of the medical procedure, including the preparatory phase (introductory song to teach deep breathing and information provision), during the procedure (coaching and active engagement in music as behavioral distraction, in addition to engaging children in non‐procedural talk about the music as a form of cognitive distraction), and recovery phase (presented a new instrument and additional songs to provide distraction). After the child had recovered and no longer displayed distress behaviors, the clinician‐researcher presented a good‐bye song to aid with completion of the procedure. 2. Standard care: The clinician‐researcher remained in the room to hold and monitor the video camera, but did not interact with the child, child’s parents, or nurse(s).
Outcomes	Pain measure: Parent‐report: UCLA Universal Pain Assessment Tool Distress measure: Parent‐report: Researcher created tool (7‐point Likert Scale) Behavioural: distress behaviors from Child‐Adult Medical Procedure Interaction Scale‐Revised (CAMPIS‐R) Adverse events: none mentioned
Notes	Study: 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)	Low risk	Quote: "web‐based randomization program" (p. 348)
Allocation concealment (selection bias)	High risk	Quote: "full allocation concealment was not possible" (p. 348)
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	Missing data balanced across groups
Selective reporting (reporting bias)	Low risk	Primary and secondary outcomes identified and fully reported
Other bias	Low risk	Appears to be free of other bias that would affect outcomes