Jeffs 2007.
Study characteristics | ||
Methods | RCT. 3 arms. | |
Participants | Number of children: 8 control, 19 distraction (10 = investigator‐selected and 9 = self‐selected) Sex of children: 17 M, 15 F Age range of children: 11 ‐ 17 years Mean age of children: 14.06 ± 2.31 years Needle procedure: phase II of allergy testing involving injection Diagnosis of child: none reported Inclusion criteria: 11 ‐ 17 years old, required environmental or food allergen testing, parental presence, ability to read and write in English Exclusion criteria: bee venom allergy testing, cognitive and developmental disability Setting: outpatient allergy testing clinic within large medical centre located in a moderate‐size metropolitan area of the northeastern United States |
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Interventions | 1. Distraction (investigator‐selected): Children watched a nursing recruitment video targeting an adolescent audience prior to and during allergy testing. 2.Distraction (self‐selected): Children selected 1 distracter from collection of music, audio books, or videos. 3.Usual care control: Received no intervention and consisted of typical communication between children and the nurse |
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Outcomes | Pain measure:
Adverse events: none mentioned |
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Notes | Phase I allergy testing was used to determine the presence of non‐reactive allergens. Distraction was resumed during Phase 2 testing, so only Phase II testing was used in the analyses for this review. Phase 1 involved an N of 32, while Phase 2 involved and N of 27; therefore, the total N reported for this study is 27. Study dates: study dates not reported Funding: grant funding was provided by the Foundation of the New York State Nurses Association and the Delta Pi chapter of Sigma Theta Tau International 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 | Participants randomly assigned "using a computer‐generated random numbers table" (p. 175 Par 2) |
Allocation concealment (selection bias) | Unclear risk | Unclear if all appropriate safeguards taken with assignment envelopes (i.e. sequentially numbered or opaque) |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "unblinded experimental design" (p. 172 Par 7) |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "unblinded experimental design" and no blinding of self‐report of outcome assessment (p. 172 Par 7) |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing data for phase included in current review |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to permit judgment of 'low' or 'high' risk |
Other bias | High risk | Multiple potential sources of bias related to study design and other problems (e.g. low statistical power) |