Pain and anxiety reduction using a manual stimulation distraction device when administering local analgesia oro-dental injections: a multi-center clinical investigation

OBJECTIVE: This study was designed to assess the effects of a manual stimulating distraction device (Isoflex referred to as Manual Stimulation Distraction Device or MSDD) for reducing pain and anxiety experienced with standard dental local anesthetic injections. Additionally, the memory recall effects on injection pain and anxiety were also explored. METHODOLOGY: Patients from different dental clinics were identified by their practitioners as requiring dental procedures under local anesthesia, in the same area on both sides of the mouth. A local anesthetic solution was injected on either the left or right side at different times by random selection; one side using MSDD, while the opposite side used a solution without MSDD. Each patient acted as his or her own symmetrical split-mouth control. The same dentist administered both injections, using identical technique and equipment for each side. Forty-six patients used the MSDD first with the injection, while 54 used MSDD second when they received the injection. Using 10-point visual analogue nominal and ordinal scales, pain and stress were recorded by the patient each time after receiving the injection. The results were pooled and subjected to statistical analysis. Student's paired t-test was employed to test for significant differences in pain and anxiety (stress) when injections were administered with and without MSDD. RESULTS: Results showed significant reductions in perceived pain and stress from local analgesia injections (p < 0.001) when MSDD was used. There was no correlation of pain reduction with age, gender, upper or lower jaw, with or without MSDD. There was a trend for pain and stress to be scored higher for those subjects who had a lower period since the first injection (POFI) scores. This was attributed to recent memory of pain, as POFI scores over one week were significantly lower (p < 0.05). Stress reduction for POFI scores greater than one week proved to be non-significant (p = 0.099). CONCLUSION: In this study, MSDD was effective at reducing pain and stress experienced with local regional analgesic injections.