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

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
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
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)
Outcomes
  • Anxiety/pain: assessed with the FLACC scale (Face, Legs, Activity, Cry, Consolability) during LA

  • Heart rate before and during LA

  • Skin conductance before and during LA (excluded from the review)

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
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