Abstract
Pediatric surgery is associated with high levels of anxiety for both children and parents/caregivers. To mitigate anxiety, auricular acupuncture has shown its potential in the perioperative setting. Accordingly, our team developed a wearable prototype auricular laser acupuncture system, AcuHealth V1.0, as a portable acupuncture device and conducted a proof-of-concept evaluation with parents of children undergoing surgery. The primary aim of this study was to conduct feasibility testing of the AcuHealth V1.0 system in delivering auricular laser acupuncture. Parents of children who were scheduled to undergo outpatient surgery were randomly assigned to one of three groups: authentic acupuncture (laser beams at known anxiolytic acupoints, n = 13), sham acupuncture (non-anxiolytic acupoints, n = 14), or a placebo control group (inactive laser, n = 14). Parent self-reported anxiety (0-10 numerical rating scale) was assessed at baseline, pre-intervention (once child was taken to the OR), post-intervention, and at 30 min after the intervention. Usability and acceptability data regarding the device were assessed after the intervention. Baseline data revealed no significant difference in anxiety between the three groups. Parent-reported anxiety level at 30-min post-intervention as compared to baseline in the authentic group was significantly decreased (delta mean ± std = -3.58 ± 2.07) compared to both the sham acupuncture (-1.35 ± 2.65) and placebo control group (0.54 ± 1.13). Evaluation of changes in parent-reported anxiety between groups over time using two-way repeated-measures analysis of variance (ANOVA) revealed a significant difference between the three groups (p = 0.001). Post hoc analysis with Scheffe test pairwise comparisons showed that at 30-min post-intervention compared to baseline, the authentic intervention group was significantly less anxious compared with both the sham group (p = 0.033) and the placebo control group (p = 0.001). Additionally, feedback regarding the usage of the device supported the acceptability and usability of the device with no adverse events. This pilot study administering laser auricular acupuncture via the AcuHealth V1.0 system decreased parental anxiety after 30 min in parents who received treatment immediately after their children were taken to the operating room with no adverse effect.
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