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.
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.
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.