ABSTRACT
OBJECTIVES: To assess the feasibility of a randomized controlled trial (RCT), evaluating the efficacy and patients' perceptions of a psychological intervention aimed at reducing anxiety levels in adults undergoing first-time colonoscopy. METHODS: Adults undergoing first-time colonoscopy were randomized to a psychological intervention vs. sham intervention. The primary outcome was feasibility, defined as a recruitment rate of >50%. Patients' state anxiety was assessed before and after the intervention using the state-trait inventory for cognitive and somatic anxiety (STICSA) score. Follow-up interviews were performed within 1 week with a sample of patients and focus groups with clinical staff. RESULTS: A total of 130 patients were recruited from 180 eligible patients (72%). Eighty were randomized and completed the study (n = 39) in the psychological intervention group and (n = 41) in the sham. In the psychological intervention group, pre- and postmedian STICSA scores were 29 and 24 (P < 0.001), respectively. In the sham group, pre- and postmedian scores were 31 and 25 (P < 0.001), respectively. Follow-up interviews with patients (n = 13) suggested that 100% of patients perceived the psychological intervention as beneficial and would recommend it to others. CONCLUSION: The study was feasible. Patients in both groups improved their anxiety scores, but there were no significant differences between arms. Despite this, patients receiving psychological intervention perceived a benefit from the relaxation exercises.
