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. 2018 Oct 4;2018(10):CD005179. doi: 10.1002/14651858.CD005179.pub4

Kristjansdottir 2010.

Study characteristics
Methods RCT. 3 arms.
Participants Number of children: 39 control, 79 treatment
Sex of children: 63 M, 55 F
Age range of children: 13 ‐ 15 years
Mean age of children: 14 ± 0.18 years
Needle procedure: polio immunization
Diagnosis of child: none (community sample)
Inclusion criteria: Icelandic‐speaking adolescents for a ninth grade immunization
Exclusion criteria: none reported
Setting: school in Iceland
Interventions 1. Music distraction (with headphones):Adolescents listened to music using headphones.
2. Music distraction (without headphones): Adolescents listened to music from loudspeakers.
3. Standard care control: Nurses maintained their normal modes of caring, which were to comfort and guide the adolescents verbally.
Outcomes Pain measure:
  • Child self‐report: 0 ‐ 10 VAS


Adverse events: none mentioned
Notes Study dates: 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: "table of random numbers was used to randomize into groups" (p. 20 Par 11)
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 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 Unclear risk Insufficient information to assess whether an important risk of bias exists