Sahiner 2016.
Study characteristics | ||
Methods | RCT. 4 arms. | |
Participants | Number of children: 30 control, 30 per treatment group (90) Sex of children: 63 M, 57 F Age range of children: 6 ‐ 12 years Mean age range of children: 9.1 ± 1.6 years Needle procedure: venipuncture Diagnosis of child: none reported Inclusion criteria: 6 ‐ 12 years, requested blood tests Exclusion criteria: none given Setting: Phlebotomy Unit of the Karaman Maternity and Children Hospital in Turkey |
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Interventions | 1. Distraction cards: Children received visual cards covered with pictures and shapes just before the procedure. The child carefully examined the cards and then the researcher asked questions about the cards (e.g. Can you see the comet?) until the procedure was complete. 2.Listening to cartoon music: Music from 15 cartoons watched by children aged 6 to 12 years was played and the child was asked to identify which cartoon the music belonged to. A new song was played when the child recognized the music until the procedure was complete. 3. Balloon Inflation: Children were given a balloon of their color choice. They were asked to inflate the balloon before the procedure and keep on inflating until the procedure was complete. Children were given the balloons to keep. 4. Control: The routine blood‐taking procedure was followed. |
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Outcomes | Pain measure:
Distress 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: "computer generated table of random numbers" (p. 4) |
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 | No missing data |
Selective reporting (reporting bias) | Low risk | Objectives clearly stated and fully reported |
Other bias | Low risk | Appears to be free of other bias that would affect outcomes |