Sample and randomization process
Anxiety, malignancy, hearing or visual difficulty, psychiatric, Depression
END STAGE RENAL DISEASE, SENILE DEMENTIA, HEPATIC ENCEPHALOPATHY, ADVERSE EVENT
A total of 274 consecutive patients, scheduled to undergo either a gastroscopy or a colonoscopy (diagnostic or therapeutic) at the outpatient department of Medical Unit of Mayo Hospital from October 2018 to February 2020, participated in the study. Written informed consent was taken from every patient prior to participation in the study. They were debriefed about the nature and purpose of the study and their role. Forty-two patients were excluded from the study because they met any of the following criteria: (1) diagnosed cases of psychiatric illnesses; (2) history of previous endoscopy; (3) undergoing emergency endoscopy (whether diagnostic or therapeutic); (4) end stage renal disease; (5) hearing or visual difficulty; (6) senile dementia; (7) pregnant or diagnosed cases of malignancy; (8) signs of hepatic encephalopathy.Two hundred thirty-two eligible patients who were enrolled in the study (see CONSORT flow chart of the participants through the trial.For gastroscopy, patients were instructed to stop eating 6 h before the procedure and stop drinking all kinds of liquids 2 h prior to the procedure. For colonoscopy, patients were given bowel preparation kits that contained Polyethylene Glycol (PEG 3350) and electrolytes. The kits were to be mixed in 1 liter of water and consumed 24 h before the procedure. Patients were instructed to stop eating once they used the kit and use clear liquids (water or oral rehydrating solutions) till the time they reported for the procedure.Patients were admitted to Medical Unit a day before endoscopy. They were shifted to endoscopy floor in the morning after a longer than 12 h fasting period. Demographic questionnaire, Depression, Anxiety and Stress Scale-42 (DASS-42) and Visual analogue scale (VAS) were administered by psychologist as baseline in a separate room. 232 patients were then randomly allocated between two groups (group 1 watched animated video of endoscopy procedure, however, group 2 didn’t watch any video) on a 1:1 ratio using permuted block randomization with a fixed block sizes of four, by a house officer who wasn’t involved in providing intervention to any group or in assisting any of the endoscopy procedures and was responsible to break the code in case of adverse event. The allocation sequence to the study conditions was kept concealed from psychologists measuring outcome variables, using sequentially numbered, opaque and sealed envelopes. The nature of the investigation required patients to be aware of what group they were in, so, the patients were not blinded to treatment group allocation. Patients were told not to inform anyone about their allocation. Patients were assured about confidentiality of their responses and their identities. They were also told that information obtained from them will only be used for academic and research purposes. No financial and other inducements were offered to the participants that were likely to coerce participation.