Impact of Counselling and Visual Aid on Anxiety in Endoscopic Patients

Inflammatory Bowel Diseases Clinical Trial

Official title:

State Anxiety Level in Patients Undergoing Upper Gastrointestinal Endoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05241158
• Other study ID #: 179/RC/KEMU
• Status: Completed
• Phase: N/A
• Start date: August 16, 2018
• Est. completion date: February 4, 2020

Study information

• Verified date: November 2022
• Source: King Edward Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: February 4, 2020
• Est. primary completion date: February 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Liver Disease
• Inflammatory Bowel Diseases
• Liver Diseases

Intervention

Behavioral:
• Counselling 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
• Counselling
Patients counselled about the procedure, complications and the post-procedure recovery phase

Locations

Country	Name	City	State
Pakistan	Mayo Hospital	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
King Edward Medical University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety	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.	90 minutes
Secondary	fear	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.	90 minutes
Secondary	Stress	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.	90 minutes