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

Mutlu 2015a.

Study characteristics
Methods RCT. 3 arms.
Participants Number of children: 44 control, 44 treatment (balloon inflation)
Sex of children: 48 M, 40 F
Age range of children: 9 ‐ 12 years
Mean age range of children: 10.39 ± 1.08 years (treatment balloon inflation), 10.36 ± 1.12 years (control)
Needle procedure: venipuncture
Diagnosis of child: none reported
Inclusion criteria: 9 ‐ 12 years, presented at the blood testing room
Exclusion criteria: taken analgesic drugs within 24 hours prior to the blood sampling procedure, had fever, mental or neurological disorders, a medical history of fainting, chronic diseases that necessitated frequent blood sampling procedures, previously undergone surgery
Setting: blood testing room of pediatric department of large research hospital in Instanbul, Turkey
Interventions 1. Balloon Inflation: Before the procedure, children were asked to choose a balloon of the color of their choice and inflate it. The balloon was then deflated. During the procedure, the child inflated the balloon again.
2. Cough Trick: [k1] Before the procedure, children were told that they would be asked to cough while their blood was being taken. As a preliminary exercise, the children were asked before the procedure to take a deep breath and then cough actively. During the procedure, the child was asked to cough.
3. Control: The usual procedure of the blood testing room was followed. Parents were allowed to accompany their children but no pain reducing intervention of any kind was applied.
Outcomes Pain measure:
  • Child self‐report: FPS‐R


Adverse events: none mentioned
Notes We did not include the cough trick group in this review, as we do not consider the intervention to be a psychological mechanism.
Study dates: April to July 2011
Funding: Research Fund of Istanbul University, Turkey
Conflicts of interest: none declared
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "using a computer program" p.179
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 High risk Reasons for missing data likely to be related to true outcome.
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.