Clinical trial NCT05241158: Impact of Counselling and Visual Aid on Anxiety in Endoscopic Patients
Official title: State Anxiety Level in Patients Undergoing Upper Gastrointestinal Endoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Liver Disease
Inflammatory Bowel Diseases
Keywords: Endoscopy
Visual Aid
Anxiety
Counselling
Lead sponsor: King Edward Medical University
Sponsor class: OTHER
First posted: 2022-02-15
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Anxiety
timeFrame: 90 minutes
Secondary outcomes:
measure: fear
timeFrame: 90 minutes
measure: Stress
timeFrame: 90 minutes
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Mayo Hospital
state: Punjab
Study officials:
affiliation: King Edward Medical University
name: Ali Asad Khan, FCPS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Child Health Sciences & The Children's Hospital, Lahore
name: Anam Ali, MS
role: PRINCIPAL_INVESTIGATOR
References: