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. 2018 Oct 4;2018(10):CD005179. doi: 10.1002/14651858.CD005179.pub4

Ramírez‐Carrasco 2017.

Study characteristics
Methods RCT. 2 arms.
Participants Number of children: 20 control, 20 treatment
Sex of children: 16 M, 24 F
Age range of children: 5 ‐ 9 years
Mean age range of children: 90 ± 17.15 months
Needle procedure: dental anesthetic
Diagnosis of child: healthy children
Inclusion criteria: participants must have never received dental care, seeking attention at the Pediatric Dentistry Clinic a t the Autonomous University of San Luis Potosi for the first time and their dental treatment had to include a local anesthetic
Exclusion criteria: none stated
Setting: pediatric dentistry clinic a t the Autonomous University of San Luis Potosi, Mexico
Interventions 1. Hypnosis: Children listened to a classic directive hypnosis intervention through headphones. The hypnosis intervention included a standard 3‐minute progressive muscle relaxation induction followed by a 5‐minute deepening procedure aimed at increasing the person's focus, absorption, and concentration. In the intervention phase the hypnotic suggestions were aimed at modifying their perception of pain. Participants were asked to visualize a safe and special garden with a fountain in the middle. They were told the fountain water would make their mouth numb and relaxed, so they would feel completely comfortable and relaxed while the dentist “made their tooth feel better". Standard conventional behavior management techniques were also used.
2. Control: Children were asked to wear headphones to block out the sound of the dental drill. Standard conventional behavior management techniques were used.
Outcomes Pain measure:
  • Behavioural: FLACC


Physiological measure:
  • Heart rate

  • Skin conductance


Adverse events: None mentioned
Notes Study dates: study dates not reported
Funding: none stated
Conflicts of interest: none declared
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomized ‐ no further details. Insufficient information to permit judgment of 'low' or 'high' risk
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgment of 'low' or 'high' risk
Blinding of participants and personnel (performance bias)
All outcomes High risk Study participants and personnel were not blinded
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "evaluators blind to the patients' group membership" (p. 2)
Incomplete outcome data (attrition bias)
All outcomes Low risk No missing data
Selective reporting (reporting bias) High risk Outcomes insufficiently reported for inclusion in meta‐analysis
Other bias Unclear risk Insufficient information to permit judgment of 'low' or 'high' risk