Binaural beats, dental anxiety, low certainty

Pooled randomised trials report less anxiety and pain during dental procedures. The reviewers grade that finding low certainty and report a high risk of bias.

Evidence context

Evidence type: Published systematic review with meta-analysis of randomised clinical trials, conducted by independent researchers with no relationship to Fluctara.
Evidence level: external replication
Population or setup: Nine trials were reviewed qualitatively and six were pooled quantitatively. Participants were children and adults aged 5 to 48 undergoing dental procedures ranging from simple restorations to third-molar extractions and orthodontic treatment, in China, Turkey, Indonesia, India, Dubai, and Iran. The intervention was binaural-beat audio delivered during the procedure; comparators were blank audio or a positive control.
Result: Anxiety measured on a visual analogue scale fell before versus after the intervention by a mean difference of 1.62 (95% CI 0.84 to 2.40), with no measurable heterogeneity between studies for that comparison. Anxiety measured with Venham's Picture Test fell by 1.36 (95% CI 0.82 to 1.89). Against a control condition, anxiety was lower by 1.50 (95% CI 0.65 to 2.34). Reported pain also fell. The reviewers concluded that dental pain and anxiety appear to be alleviated, and that clinicians may view the technique as a viable non-pharmacological option.
Uncertainty: The reviewers graded the certainty of this evidence as low. They found a high risk of selection and detection bias across the included trials: most lacked allocation concealment, and blinding of outcome assessment was generally inadequate. Heterogeneity varied from none to 94 per cent depending on which comparison was pooled, meaning some pooled estimates combine trials that disagree substantially. Anxiety and pain in these trials were measured by self-report scales, which are sensitive to expectation.

Limitations

Certainty of evidence was graded low by the reviewers themselves; this is a signal about the underlying trials, not about the arithmetic of the pooling.
High risk of selection and detection bias was found across the included studies.
Heterogeneity reached 94 per cent for some comparisons, so a single pooled number can conceal disagreement between trials.
Trials published in languages other than English were excluded, and access to unpublished work was limited, so publication bias cannot be ruled out.
Every included trial studied a dental procedure. Nothing here establishes what happens outside a procedural setting, and Fluctara sessions are not a procedural setting.
The trials tested binaural-beat audio in general. None of them tested audio generated by Fluctara.
A group-level average says nothing about what any individual experienced, including individuals who got worse.

Evidence references

Effectiveness of Binaural Beats in Reducing Dental Pain and Anxiety among Children and Adults: A Systematic Review and Meta-analysis. Available at https://pmc.ncbi.nlm.nih.gov/articles/PMC12451561/ — full text reviewed 2026-08-29. Declared funding: none. Declared conflict of interest: none.
Registered in PROSPERO, January 2024, as recorded in the review's own methods section.

Correction history

No correction is published for this revision.

Related programme

No public programme relationship is approved for this record.