Karst 2007.
Methods | Design: four group parallel trial Purpose: study the effect of auricular acupuncture on dental procedural anxiety | |
Participants | Patients: outpatients undergoing dental extraction Baseline comparability: yes | |
Interventions | Placebo: needling with non penetrative needle at points not regarded having effect on anxiety (finger and liver points)
Untreated: no needling
Experimental: ‐needling at ' ... relaxation, tranquillizer, and master cerebral points in the external ear ...'. ‐midazolam, intranasal (average dose 4mg) (Co‐intervention: NS) |
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Outcomes | Spielberger state‐trait anxiety inventory VAS Sedation score Quality of dental condition Physiological status | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Low risk | 'list of random numbers' |
Allocation concealment? | Unclear risk | NS |
Blinding? Treatment provider | High risk | Not described as double‐blind (placebo/acupuncture) |
Blinding? Outcome assessor | Unclear risk | Not relevant as patient reported outcome |
Incomplete outcome data addressed? All outcomes | High risk | Drop‐out > 15% or NS |
Free of selective reporting? | Unclear risk | No protocol available |
Free of other bias? | Low risk | |
No signs of variance inequality or skewness? | Low risk | No variance inequality (F‐test not statistically significant) and no skewness (1.64 standard deviations does not exceed the mean) |
Trial size > 49? | High risk | N = 29 |
Clearly concealed allocation + trial size > 49 + drop‐out max 15% | High risk | Trial size < 49 |