Carrasco 2017.
Methods | Study design: randomised trial, parallel Location: Mexico Number of centres: 1 Setting: clinic at the university Recruitment period: not reported Funding source: not reported |
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Participants | Inclusion criteria: patients must have never received dental care and had to be seeking attention at the university for the first time and their dental treatment had to include LA Exclusion criteria: not defined Number of participants randomised: 40 Number of participants evaluated: 40 Number of males/females: 16 males, 24 females Age range: 5 to 9 years Mean age (months): 90, SD: 17.15 No reporting of the group age |
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Interventions | Group 1: hypnosis. Patients had headphones with a record of guided hypnosis playing during appointment Group 2 (control group): patients had headphones with no sound (to block the drill noise with no audio) |
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Outcomes |
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Notes | Observers were trained and inter‐rater reliability obtained Consent and ethical approval obtained Sample size calculation made, however the sample number were small and we are not sure if it can show a difference or not No reference to previous published protocol |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of randomisation has not been reported |
Allocation concealment (selection bias) | Unclear risk | No discussion regarding allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding of patients was not discussed. However, the authors reported that patients were asked to wear headphone to blind the outcome assessor only. Furthermore, it seems impossible to blind the operator as the headphones for patients in the hypnosis group were playing audio during the treatment while patient in the other group had no audio |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Patients in the trail were asked to wear headphones to maintain the FLACC evaluators blind to the group membership. However, children in the experimental group were asked to raise their hand before LA according to the authors and there is no mention if the children in the control group did the same or not |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Only 1 appointment so possibly no dropouts |
Selective reporting (reporting bias) | Low risk | All recorded outcomes were reported on within the results section |
Other bias | High risk | The authors did not report on patient characteristic and demographics data in the study. Furthermore, the patients in the control group were asked to wear headphones to block drill noise according to the authors which could have introduced bias |