Evaluation of a multisensory hypnosis mask during transrectal ultrasound-guided prostate biopsy: Results of a randomized controlled trial.

Abstract

Objectives: To assess whether the Hypnos Pro® mask - a multisensory hypnosis-based device combining light stimulation, auditory guidance, and hypnotic narration - reduces pain and anxiety during transrectal ultrasound-guided prostate biopsy (TRUS-Bx).

Methods: This randomized controlled trial compared TRUS-Bx performed with or without the Hypnos Pro® mask. Initially designed to include 172 patients, the study was prematurely stopped after randomization of 99 participants due to changes in clinical practice (Hypnos Pro® group, n=49; control group, n=50). Pain intensity was assessed using a Visual Analogue Scale (VAS) 20minutes after probe removal. Anxiety was measured using the Spielberger State-Trait Anxiety Inventory (STAI-YA). Secondary outcomes included procedure characteristics, patient willingness to repeat the biopsy, and staff satisfaction.

Results: Eighty-eight patients were analyzed (Hypnos Pro®: n=45; control: n=43). Median pain VAS scores were significantly higher in the Hypnos Pro® group than in controls (2.2 [1.2-4.8] vs. 1.4 [0.5-3.2]; P=0.038). After stratified analysis adjusting for prior biopsy history and education level, this difference did not reach statistical significance (P=0.10). Changes in STAI-YA scores did not differ significantly between groups (-5.1±9.0 vs. -6.6±8.8; P=0.56). Procedure duration and number of biopsy cores were comparable between groups. Willingness to repeat the procedure was similar (84% vs. 91%; P=0.40).

Conclusion: The use of the Hypnos Pro® mask did not reduce pain or anxiety during TRUS-guided prostate biopsy. Pain scores were higher in the mask group in the unadjusted analysis, but this difference did not remain significant after adjustment for baseline imbalance. These findings do not support the routine use of multisensory hypnosis devices during prostate biopsy. Further studies are warranted to clarify the impact of sensory isolation devices on patient comfort during prostate biopsy.

Level of evidence: level 3.