Abstract
Abstract Background Crohn’s disease (CD) is a chronic, immune-mediated condition associated with abdominal pain, psychological comorbidities, and reduced quality of life (QoL), even in remission. Clinical hypnosis, involving focused relaxation and therapeutic suggestion, is helpful for irritable bowel syndrome, pain, and anxiety, and may have anti-inflammatory effects. Study Aims: To implement hypnosis as an adjunctive therapy for adolescents with CD. To assess the impact on QoL, abdominal pain, psychosocial measures, and disease activity compared to standard care. Methods Forty 12–18 year-olds with CD diagnosed >3 months prior randomized to hypnosis intervention (HI) or waitlist control (WC). HI receive one in-person hypnosis session focused on enhancing comfort, calm, and energy; education on self-hypnosis; audio recordings for 8 weeks home practice. Assessments at 8 and 16 weeks. Primary outcome: disease-specific health-related (HR) QoL Impact III, single-item QoL modified Cantril Scale, parent-proxy HRQoL PedsQL 4.0. Secondary outcomes: Anxiety, Depressive Symptoms, Sleep Disturbance (PROMIS pediatric short forms); abdominal pain frequency and intensity; Pain Beliefs Questionnaire short form (PBQ-SF); school absences; healthcare utilization; Physician’s Global Assessment (PGA); Pediatric Crohn’s Disease Activity Index. With n=40, 80% power to detect 13-point difference in Impact III. Two-sided Wilcoxon test used to compare differences from baseline to follow up and between groups. Results Demographics: 40 participants enrolled February-May 2019. 50% female. 15.8 y ± 2. PGA: 28 quiescent, 6 mild, 3 moderate, 3 not documented. 18, 8, and 13 of 40 with moderate-severe depressive symptoms, anxiety, and sleep disturbance, respectively. 25 of 40 with abdominal pain in the past week. WC with poorer systemic symptom-related QoL by Impact III (p=0.01) and greater depressive symptoms (p=0.03) compared to HI. Post-Intervention (8 Weeks): In HI and not in WC, significant improvement was noted in parent-reported QoL (p=0.006; Figure 1), maximum abdominal pain intensity (p=0.01, Figure 2), PBQ-SF subdomain emotion-focused coping efficacy (p=0.04), and school absences (p=0.03). 50% of HI participants used self-hypnosis at least 3–4 times per week and tended to have greater QoL improvement than those who practiced less. Participants described improvement in stress, anxiety, and sleep, though corresponding measures were unchanged. 16-week outcomes and disease activity pending. Conclusions Adolescents with CD have pain, reduced QoL, and psychological impairment despite inactive disease. Hypnosis is an acceptable, feasible, and promising complementary therapy in CD and may improve QoL, abdominal pain, coping efficacy, and school attendance. Additional RCTs with longer follow up, objective disease activity assessment, and measures to improve compliance are warranted.
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