2885 Reducing Anxiety in Patients Undergoing First-Time Colonoscopy: A Pilot and Feasibility Study for a Randomized Controlled Trial

INTRODUCTION: Patients undergoing colonoscopy may experience pre-procedure anxiety, which is associated with increased pain and might affect the willingness to undergo subsequent studies. We hypothesised that a brief psychological intervention would reduce anxiety before colonoscopy. The aim of the pilot study was to evaluate the feasibility of conducting a randomized, controlled trial (RCT) of the efficacy of a psychological intervention (PsI) in reducing anxiety levels in adult patients undergoing first-time colonoscopy under conscious sedation. METHODS: We performed a mixed method, double-blinded RCT of adult patients undergoing first-time colonoscopy. Eligible patients were randomized to a PsI vs. sham PsI. The primary outcome was feasibility, with success defined a priori as recruitment rate >50%. All participants had an anxiety assessment pre- and post-intervention using State-Trait Inventory for Cognitive and Somatic Anxiety (STICSA) score.Pre- and post-intervention scores were compared within and between groups. Secondary outcomes included sedation dose, patient comfort, cecal intubation rate and willingness to repeat colonoscopy. RESULTS: In total, 130 patients were recruited from 180 eligible participants (72%). Eighty were randomized and completed the study (44%).Failure to randomize recruited patients was due to logistical scheduling issues after patient arrival (26/50: 52%). Baseline characteristics were similar among groups (Table 1). In the PsI group, pre- and post-intervention median STICSA scores were 29 and 24 ( P < 0.001), respectively. In the sham group, pre and post median scores were 31 and 25 ( P < 0.001), respectively. There were no significant differences between the groups for any other secondary outcomes (Table 2). Although not statistically significant, the PsI group had fewer patients unwilling to repeat a colonoscopy and a higher cecal intubation rate than the sham PsI group. CONCLUSION: We have shown that it is feasible to recruit patients to an RCT evaluating PsI in colonoscopy and identified potentially remediable administrative challenges that reduced study completion rates. In addition, anxiety scores in both groups improved following colonoscopy although we did not observe a significant difference between treatment arms. Both findings are key to adjust future study design (e.g. a third arm that receives usual care). Currently, a qualitative assessment is underway to evaluate participant and staff acceptance of the study design and intervention.