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. 2020 Feb 27;2020(2):CD011024. doi: 10.1002/14651858.CD011024.pub2

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
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
Interventions Group 1: hypnotic induction to administer LA
Group 2: LA without hypnotic induction
Outcomes
  • Physical and verbal resistance: resistance to delivery of LA, such as high hand movements, leg movements, crying or verbal protests and/or orophysical resistance. Assessed by independent observer blinded to intervention

  • Pulse rate: measured at baseline, at tissue penetration and on administration of LA

  • Change in oxygenation level: from baseline until LA delivery

Notes Declarations of interest: not reported
No sample size calculation
Ethical approval and consent obtained
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)