Gold 2006.
Study characteristics | ||
Methods | RCT. 2 arms. | |
Participants | Number of children: 10 control, 10 treatment Sex of children: 12 M, 8 F Age range of children: 8 ‐ 12 years Mean age of children: 10.2 years Needle procedure: IV Diagnosis of child: heterogeneous, 12/20 had “medical conditions” Inclusion criteria: awaiting MRI or CT scans, required IV placement Exclusion criteria: children with known or reported cognitive disabilities, taking pain medication, did not pass the cognitive and physical screening Setting: Department of Radiology at Childrens Hospital Los Angeles, United States |
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Interventions | 1. Virtual reality distraction: Standard care and VR game presented through a head‐mounted display, which began 5 minutes before IV placement and continued for 5 minutes afterwards 2. Standard care control: Topical anesthesia spray prior to IV placement |
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Outcomes | Pain measure:
Adverse events: none mentioned |
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Notes | Study dates: study dates not reported Funding: donation 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 | Stratified according to age (7‐9, 10‐12), then randomized to condition ‐ no further details. Insufficient information to permit judgment of 'low' or 'high' risk |
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 | Participants and personnel 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) | High risk | One or more outcomes of interest are reported incompletely (i.e. nurse and parent report) |
Other bias | High risk | Small sample size potential source of bias affecting outcomes |