Nurse-Led Intervention to Reduce Parental Anxiety and Child Pain During Non-Therapeutic Male Circumcision: A Randomized Trial.

Introduction: Non-therapeutic male circumcision is often performed in outpatient settings and has physical and emotional implications for children and families. Objective: To evaluate the effectiveness of a nurse-led intervention in reducing parental anxiety and child pain during non-therapeutic male circumcision. Methods: An open-label, parallel-group, randomized trial was conducted at Policlínica Maresme (Spain) for review between March and May 2022. A total of 314 family members and 192 children aged 0 to 3 years were randomly assigned (1:1) to either a nurse-led intervention or standard care. The intervention included a face-to face preoperative educational session, guided use of non-pharmacological pain relief techniques during surgery, and structured postoperative follow-up. The control group received routine care comprising written postoperative instructions and follow-up calls. Primary outcomes were preoperative parental anxiety, assessed using the Hamilton Anxiety Rating Scale (HAM-A), and immediate postoperative child pain, measured with the Face, Legs, Activity, Cry, Consolability (FLACC) tool. Secondary outcomes included pain at 24 to 48 hours and 8 to 10 days, caregiver-reported home care difficulties, and complication rates. Results: Baseline parental anxiety did not differ between groups (mean difference -0.29; 95% confidence interval [CI] -2.22 to 1.64). Children in the intervention group had significantly lower postoperative pain (mean FLACC 0.72 vs. 1.39; mean difference -0.66; 95% CI -0.98 to -0.35) and were more often pain-free (55.4% vs. 32.6%; odds ratio [OR] 2.55; 95% CI 1.42-4.59). Pain at 24 to 48 hours and caregiver-reported difficulties were also reduced. No group differences were found in complication rates. Conclusion: The nurse-led intervention improved children's pain outcomes and caregiver preparedness for home care, although it did not significantly reduce parental anxiety. Structured, nurse-led education combined with non-pharmacological strategies can enhance pediatric pain management and caregiver preparedness, particularly in healthcare settings where non-therapeutic male circumcision is performed for cultural or religious reasons. Trial Registration: ClinicalTrials.gov: NCT05387291.