Nilsson 2015.
Study characteristics | ||
Methods | RCT (randomized cross‐over trial). 2 arms. | |
Participants | Number of children: 20 control first, 17 treatment first Sex of children: 0 M, 37 F Age range of children: 11 ‐ 12 years Mean age range of children: not reported Needle procedure: vaccination Diagnosis of child: none reported Inclusion criteria: 11 ‐ 12 years, receiving 3 HPV vaccinations Exclusion criteria: none given Setting: three schools in western Sweden |
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Interventions | 1. Relaxation and guided imagery: Nurses provided relaxation and guided imagery during the procedure. Children were encouraged to progressively relax their muscles and think about something positive. The nurse encouraged them to engage in the fantasy by asking detailed questions about it. 2. Standard care: Standard care was performed according to regulations. The nurses were instructed to talk as they normally do during vaccinations without any systematic relaxation or other non‐pharmacological or pharmacological intervention. |
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Outcomes | Pain measure:
Distress measure:
Physiological measure:
Adverse events: none mentioned |
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Notes | Outcomes included from time 1 only (before the cross‐over to other condition) Study dates: September 2012 to September 2013. Funding: grants from the Ebba Danelius Foundation, Swedish Association of Paediatric Nurses, the Gertrud Östlinder Foundation and the Jerring Foundation. 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: "using a computer program (randomizer.org)" (p. 726) |
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 | Some missing data but likely not related to outcomes of interest |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to permit judgment of 'low' or 'high' risk |
Other bias | Low risk | Appears to be free of other bias that would affect outcomes |