Nguyen 2010.
Study characteristics | ||
Methods | RCT. 2 arms. | |
Participants | Number of children: 20 control, 20 treatment Sex of children: 25 M, 15 F Age range of children: 7 ‐ 12 years Mean age of children: 8.8 ± 1.59 years (intervention); 9.4 ± 1.93 years (control) Needle procedure: LP Diagnosis: leukemia Inclusion criteria: 7 ‐ 12 year olds, with leukemia, due to undergo a LP Exclusion criteria: significant hearing or visual impairment, cognitive disorder Setting: hospital oncology ward at NHP, Hanoi, Vietnam |
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Interventions | 1. Music distraction: Children listened to music using earphones beginning 10 minutes prior to the procedure. 2. Control: Children wore earphones without music beginning 10 minutes prior to the procedure. |
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Outcomes | Pain measure:
Distress measure:
Physiological measure:
Adverse events: none mentioned |
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Notes | Study dates: November 2007 to July 2008. 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) | Unclear risk | Randomized ‐ no further details. Insufficient information to permit judgment of 'low' or 'high' risk |
Allocation concealment (selection bias) | Unclear risk | Unclear if all appropriate safeguards taken with assignment envelopes (i.e. sequentially‐numbered or sealed) |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants were not blinded |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No blinding of self‐report outcome assessment |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing data |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to permit judgment of 'low' or 'high' risk |
Other bias | High risk | Potential source of bias related to measurement of outcomes |