Pilot randomized controlled trial of a hypnosis intervention for women with bladder pain syndrome.

Abstract

To evaluate the feasibility and acceptability of a randomized controlled trial of a hypnosis intervention for the treatment of bladder pain syndrome/interstitial cystitis (BPS/IC) in women. We conducted a parallel arm, non-blinded, pilot randomized controlled trial of standardized hypnosis sessions including a hypnosis web tool versus usual care in adult women with BPS/IC. Pilot study outcomes included feasibility domains: process, resources and management, safety, and acceptability. Clinical outcomes of lower urinary tract symptoms and quality of life were measured using validated questionnaires at baseline and at the end of the 4-week intervention. We randomized 29 out of 30 (96.7%) eligible women. In the hypnosis group, 12 of 15 (80.0%) subjects completed the 4-week intervention and follow up, and 13 of 14 (92.9%) in the usual care group. In the hypnosis group, adherence to the standardized sessions was 80% and participants used the web-based tool for an average of 5.6 ± 2.7 times per week. Scores for emotional distress, relaxation, pain severity and expected bladder symptoms significantly improved during the first two of three planned hypnosis sessions (all p < 0.05). Improvement in quality of life scores was greater in the hypnosis group than the usual care group (-2.6 ± 2.3 vs. -0.9 ± 1.1, p = 0.04). There were no significant between-group differences in urinary symptoms or bladder pain. No adverse events were reported. A hypnosis intervention for the treatment of bladder pain syndrome/interstitial cystitis is feasible, acceptable, safe, and may improve quality of life.