Chronic Liver Disease, Inflammatory Bowel Diseases
Conditions
Keywords
Endoscopy, Visual Aid, Anxiety, Counselling
Brief summary
A single blind randomized controlled trial was conducted to compare the effect of counselling and visual aid on the anxiety levels in patients undergoing endoscopy and to investigate the superiority of visual aid over psychological counselling and preparation for the procedure in an informed patient.
Detailed description
A single blind RCT was conducted to assess level of state anxiety between two interventional groups; counselling group and video group. 232 consecutive patients were enrolled from the outpatient department who were scheduled to undergo either a gastroscopy or a colonoscopy (diagnostic or therapeutic). The patients were randomly allocated to one of the two intervention groups (A and B) at the time of endoscopy scheduling. All of the patients received regular instructions regarding gut-preparation at the time of appointment and were also provided with written clear instructions. A gastroenterologist provided information about endoscopy, including the exact preparation instructions and information on the importance of bowel preparation and the adverse effects of the agents used. Depression Anxiety Stress Scale-42 was administered at baseline. Intervention group A (counselling group) was counselled about the procedure, complications and the post-procedure recovery phase and Group B (video group) was also counselled and shown a 5 minutes animated video of the respective procedure in separate room by gastroenterologist. Endoscopies were carried out by trained doctors (endoscopists) with a minimum experience of 1000 endoscopic procedures. Patients in both the groups were interviewed again after the intervention using Depression Anxiety Stress Scale-42.
Interventions
BEHAVIORALCounselling with visual aid
patients were counselled about the procedure, complications and the post-procedure recovery phase and shown a 5 minutes animated video of the gastroscopy or colonoscopy procedure
BEHAVIORALCounselling
Patients counselled about the procedure, complications and the post-procedure recovery phase
Sponsors
King Edward Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
The randomisation process was performed by a house officer who was not involved in performing 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. Patients were told not to inform anyone about their allocation.
Intervention model description
The 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. The allocation sequence to the study conditions was kept concealed from psychologists measuring outcome variables, using sequentially numbered, opaque and sealed envelopes.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* both genders (male or female) with a minimum age of 18 years * Able to comprehend questions being asked in Urdu language * Mentally competent at signing the consent form
Exclusion criteria
* Patients who were diagnosed cases of psychiatric illnesses * Undergoing emergency endoscopy (whether diagnostic or therapeutic) * End stage renal disease * Hearing difficulty * Senile dementia * Pregnant or diagnosed cases of malignancy * Signs of hepatic encephalopathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety | 90 minutes | Depression Anxiety Stress Scale-42 (DASS-42) was used to measure state anxiety of the patients undergoing endoscopy before and after intervention.. Score on anxiety scale ranges from 0 to 20+. 0-7 is normal, 8-9 is mild, 10-14 is moderate, 15-19 is severe and 20+ is extremely severe anxiety. The higher score on anxiety scale, the higher the level of anxiety among participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| fear | 90 minutes | Visual analogue scale was used to measure fear of the patients undergoing endoscopy before and after intervention. Participants were asked to rate the intensity of fear on a scale of 0-10. 0 means no fear and 10 means worst fear possible. |
| Stress | 90 minutes | Depression Anxiety Stress Scale-42 (DASS-42) was used to measure stress of the patients undergoing endoscopy before and after intervention. Score on stress scale ranges from 0 to 34+. 0-14 is normal, 15-18 is mild, 19-25 is moderate, 26-33 is severe and 34+ is extremely severe stress. The higher score on stress scale, the higher the level of stress among participants. |
Countries
Pakistan
Outcome results
None listed