Sample size {14}
To calculate the number of patients needed in this trial, we have used a power of 80% and an alpha level of 5% (0.05) and used outcome differences observed in previous studies. We need to include at least 106 patients, with 53 patients in the intervention arm and 53 in the comparison arm to be able to detect a clinically relevant 13.8 (SD ± 25) mean difference in change between the groups on the IBDQ scale based on the similar changes observed in studies by Ng, Millard [