Huet 2011.
Study characteristics | ||
Methods | RCT. 2 arms. | |
Participants | Number of children: 15 control, 14 treatment Sex of children: 16 M, 13 F Age range of children: 5 ‐ 12 years Mean age of children: not reported (median = 8 years and 9 years) Needle procedure: local dental anesthetic Diagnosis of child: none Inclusion criteria: not reported Exclusion criteria: not reported Setting: Department of Pediatric Dentistry at Rennes University Hospital, France |
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Interventions | 1. Hypnosis: Hypnosis followed the 3‐step Ericksonian procedure and was directed by a trained hypnotherapist. Hypnotic induction began in the dentist’s chair and focused on images, suggestions, and stories of interest to the child identified during an initial interview. The hypnotherapist spoke throughout the dental anesthesia and treatment, incorporating aspects of the intervention. 2. Standard care control: Children underwent the same procedures without hypnosis. The initial interview included reassuring explanations about the usual protocol. |
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Outcomes | Pain measure:
Distress measure:
Adverse events: none mentioned |
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Notes | Study dates: over a 3‐month period with year 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) | Low risk | Quote: "randomly assigned by lottery" (p.426) |
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 | High risk | No blinding of outcome assessment |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Missing data minimal and unlikely to be related to true outcome |
Selective reporting (reporting bias) | High risk | One or more outcomes of interest are reported incompletely |
Other bias | High risk | Multiple potential sources of bias related to study design and other problems |