Skip to main content
. 2018 Oct 4;2018(10):CD005179. doi: 10.1002/14651858.CD005179.pub4

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
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.
Outcomes Pain measure:
  • Child self‐report: Color Analogue Scale (CAS)


Distress measure:
  • Child self‐report: verbal rating scale for stress (0 ‐ 10)


Physiological measure:
  • Salivary cortisol (nmol/L)


Adverse events: none mentioned
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
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