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 |
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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. |
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Outcomes | Pain measure:
Adverse events: none mentioned |
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Notes | Study dates: study dates not reported Funding: none stated Conflicts of interest: none declared |
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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 |