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 |
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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. |
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Outcomes | Pain measure:
Adverse events: none mentioned |
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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 |
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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. |