Randomized trial comparing hypnosis versus standard management on patient anxiety and pain during pelvic brachytherapy applicator removal.

Abstract

Purpose: Removal of brachytherapy applicator is routinely performed under premedication including Kalinox® gas inhalation without general anesthesia. The applicator removal is nevertheless associated with discomfort, anxiety or pain. We assessed the adjunction of formal hypnosis during this procedure.

Methods and materials: This prospective, randomized, single-center study focused on adult patients undergoing pelvic brachytherapy applicator removal. Patients were randomly assigned to (1:1): standard management including Kalinox® (control group) vs. standard management including Kalinox® accompanied by formal hypnosis (hypnosis group). The primary endpoint was anxiety using the State-Trait Anxiety Inventory (STAI) Y-A form (state anxiety). A secondary endpoint was pain after applicator removal (numerical scale).

Results: A total of 68 patients (mean age, 51.9 years) were included (cervical cancer, 86.6%). Before applicator removal, mean (SD) STAI Y-A anxiety score was 45.9 (5.6) in the control group vs. 47.5 (5.9) in the hypnosis group. After applicator removal, the scores were 48.1 (4.3) versus 47.7 (4.2), respectively (p = 0.76). Pain score was not significantly different after applicator removal (p = 0.055) in the hypnosis group compared to the control group: 1.29 (1.72) versus 0.71 (1.51), respectively. There were no significant differences between the 2 groups concerning caregiver satisfaction with patient management (p = 0.27), ease of realization (p = 0.17) and caregiver comfort (p = 0.42).

Conclusion: This study failed to demonstrate a substantial benefit of formal hypnosis on anxiety in patients undergoing pelvic brachytherapy applicator removal. But this study suggests that the use of hypnotic communication techniques enables a positive attitude to patient care, thus reinforcing the patient-caregiver relationship.