Huang 2016.
| Methods | Trial design: RCT, 3 groups Location: Orthodontic Department of the West China Hospital of Stomatology, Chengdu, China. Number of centres: 1 |
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| Participants | SELECTION CRITERIA Recruited from among 54 right‐handed healthy young medical college students after they provided written informed consent. (i) aged 22 ± 3 years; (ii) mild‐to‐moderate malocclusion and no previous orthodontic treatment; (iii) no oral diseases which may lead to pain perception (i.e. toothache, periodontitis, oral ulcer, pulpitis) within 1 week; (iv) no infectious diseases or systemic diseases or both; (v) pain threshold from 3 to 60 seconds; and (vi) pain tolerance < 5 min, as reflected by the cold pressor test (CPT). EXCLUSION CRITERIA Psychiatric issues, abnormal pain perception, and excessive anxiety or depression based on screening by the CPT with EEG monitoring and a series of questionnaires, including the Short‐form McGill Pain Questionnaire, the Trait‐Anxiety Inventory, the State‐Anxiety Inventory, and the Self‐Rating Depression Scale. Participants: 36 (gender distribution not given) Number randomised: 36 (cognitive behavioural therapy: 12; brain wave music: 12; control: 12) Number evaluated: 36 (cognitive behavioural therapy: 12; brain wave music: 12; control: 12) Mean age: 22 ± 3 years |
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| Interventions | INTERVENTIONS: Cognitive behavior therapy or brain wave music both lasted for approximately 3 minutes. There was a verbal introduction (2 minutes) before and a silent period (5 minutes) after each intervention, the intervention therefore lasted 10 minutes overall. CONTROL: No special instructions |
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| Outcomes | VAS scores recorded daily 1 to 10 days, then at 14 and 30 days after initial orthodontic appliance placement | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "A stratified block randomisation was performed before the treatment... One individual in each block was randomly assigned to the BWM group, the CBT group or the control group, via a computer‐generated sequence." (p. 2) |
| Allocation concealment (selection bias) | Low risk | "Group allocation was performed by a Chinese Clinical Trial Registry statistician" (p. 2) |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Operators were blinded to group allocation. "One individual in each block was randomly assigned to the BWM group, the CBT group or the control group, via a computer‐generated sequence performed by a Chinese Clinical Trial Registry statistician. The clinicians and data analysts were blinded to the allocation. Separately, in isolated rooms, the three groups received the same 15‐min instruction regarding orthodontic treatment, tooth‐movement pain, oral hygiene maintenance and the respective study procedures." |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Data analysts were blinded. As described in blinding section above, trial authors considered participants to be blinded but it is unclear if this would have been effective as placebo was not used. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No losses |
| Selective reporting (reporting bias) | Low risk | Study protocol not available, but outcomes mentioned in the methods section appeared to have been reported |
| Other bias | Low risk | Appeared to be free of other forms of bias |