Abstract
PURPOSE: The research examined whether lidocaine spray application to the cervix would decrease the pain experienced during procedures. METHOD: A double-blind randomised controlled trial included 294 women from July 2022 through February 2023. The study participants received either lidocaine spray (n = 147) or placebo (n = 147) through computerized randomization. The visual analogue scale measured patient pain at six distinct points throughout the procedure. The Beck scales evaluated patients’ levels of anxiety and depression. The main outcome variables consisted of pain measurements obtained during hysterometry and device insertion. The sample size was determined based on prior studies to detect a clinically meaningful difference in VAS scores. Trial registration: ClinicalTrials.gov Identifier: NCT07155785, registered on 13 March 2024. RESULTS: The lidocaine spray group reported an average device insertion pain score of 4.18 ± 3.28 while the placebo group reported 4.24 ± 3.51 (p = 0.788). The pain scores during hysterometry did not differ between groups (3.44 ± 2.77 vs. 3.33 ± 2.93; p = 0.718). Both treatment groups reported severe pain to the same extent with approximately 27% of patients. The pain levels of women increased significantly when their anxiety scores were high regardless of the treatment they received (p < 0.05). Minor variations in operator technique and individual psychophysical differences may have contributed to pain perception but were equally distributed between groups. CONCLUSION: The application of lidocaine spray failed to provide any pain relief during intrauterine device insertion procedures. Anxiety levels directly affected how much pain patients experienced. It was understood that psychological preparation prior to the procedure may be more important than physical interventions.