Goel 2017.
Study characteristics | ||
Methods | Study design: randomised, cross‐over trial Location: Ghaziabad, India Number of centres: 1 Recruitment period: not reported Funding source: self‐funded |
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Participants | Inclusion criteria: patients requiring impression of the maxillary arch; patients with Gagging Severity Index scores of 3 to 5 Exclusion criteria: not reported Age: 4 to 14 years old Gender: male: 17; female: 23 Number randomised: 40 Number evaluated: 40 |
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Interventions | Intervention: diode laser with a penetration depth of few millimetres in a defocused continuous mode applied on P6 acupressure point (output 0.5 mW, wavelength 940 nm, energy 4J) Total number of intervention groups: 2 (cross‐over design):
Control: no laser Duration of treatment: 1 minute Duration of follow‐up: no follow‐up |
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Outcomes | Completion of dental procedure: not reported Reduction in gagging as assessed by researcher/dentist: dichotomous: presence or absence of gagging Assessed by participant: not reported Health‐related quality of life: not reported Adverse effects: not reported |
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Notes | Sample size calculation: reported. Data from pilot study was used, pooled variance S2 = 1.58 and mean difference d = 1.385 Key conclusions of the study authors: "LLLT on PC6 point was found to be effective in lowering anxiety levels as observed by faces modified anxiety rating scale. Further, it was authenticated as the pulse rates were significantly reduced and oxygen saturation levels were significantly increased. Also, gag reflex was significantly controlled when LASER stimulation was done at PC6" |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method not reported. Quote: "The patients were randomly assigned into two groups Group A and Group B" |
Allocation concealment (selection bias) | Unclear risk | Method not reported |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Method not reported |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Method not reported |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropouts. All subjects completed the study |
Selective reporting (reporting bias) | Low risk | All outcomes described were reported. Conclusions are in accordance with the results |
Other bias | Unclear risk | We are not sure regarding the carry‐over effect of the laser treatment |