Oberoi 2016.
Methods | Study design: randomised controlled study Location: India Number of centres: not reported Setting: not reported Recruitment period: not reported Funding source: not reported |
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Participants | Inclusion criteria: child needing a pulp therapy in primary or permanent mandibular molars, no previous dental experience and were ASA I Exclusion criteria: not reported Number of participants randomised: 200 Number of participants evaluated: 200 Number of males/females: 94 males (Group 1: 48, Group 2: 46); 106 females (Group 1: 52, Group 2: 54) Age range: 6 to 16 years |
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Interventions | Group 1: hypnotic induction to administer LA Group 2: LA without hypnotic induction |
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Outcomes |
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Notes | Declarations of interest: not reported No sample size calculation Ethical approval and consent obtained |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "The method of allocation consisted of creating 200 slips of equal size and shape, 100 marked with I and 100 marked with II. The slips were folded and pooled in a bowl and shuffled. Each child was asked to pick a slip from the bowl" |
Allocation concealment (selection bias) | Unclear risk | Not discussed whether the slips and the bowl were opaque and if the children and investigators could see allocation. Quote: "The slips were folded and pooled in a bowl and shuffled. Each child was asked to pick a slip from the bowl" |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not discussed but would not be possible to blind either |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quotes: "A second observer, blinded to whether the child had received hypnosis, was called into the operatory by pressing a button that gave a signal in the adjoining room" and "independent statistician who was blinded to the group assignment" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No excluded participants |
Selective reporting (reporting bias) | Low risk | All recorded outcomes were reported within the results section |
Other bias | High risk | Wide age range, with no division into groups for analysis. No discussion of ages of patients in each group, although authors calculated a statistically significant correlation between age and resistance in the experimental group (Group 1) |