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 |
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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. |
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Outcomes | Pain measure:
Physiological measure:
Adverse events: None mentioned |
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Notes | Study dates: study dates not reported Funding: none stated Conflicts of interest: none declared |
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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 |