Impact of Counselling and Visual Aid on Anxiety in Endoscopic Patients

Not Applicable

Completed

• Conditions: Chronic Liver Disease; Inflammatory Bowel Diseases
• Interventions: Behavioral: Counselling with visual aid; Behavioral: Counselling

• Registration Number: NCT05241158
• Lead Sponsor: King Edward Medical University

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.

Study Timeline

• Study Start: 2018-08-16
• Primary Completion: 2020-02-04
• Study Completion: 2020-02-04
• Study First Submitted: 2022-02-05
• Study First Submitted QC: 2022-02-05
• Study First Posted: 2022-02-15
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-16
• Last Update Posted: 2022-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Counselling with visual aid	Group B: Video group Patients in the visual aid group (video group) were provided with the same information mentioned in intervention group A. In addition to that, patients watched a 5 minutes video of the respective procedure. Video showed the animation of a gastroscopy or colonoscopy procedure with a voice over explaining all the steps of the procedure in addition to the pre and post-procedure precautions to be observed.
Group A	Counselling	Group A: Counselling group Patients were given a briefing about the procedure; the use of local anesthetic along with potential benefits and side effects of the drug. The steps of the endoscopy procedure (gastroscopy or colonoscopy) were explained in detail including the position, intubation, biopsy or intervention wherever applicable, extubation and post-procedure observation period in the recovery room. Detailed instructions were provided regarding post-procedural care, introduction of diet \& follow-up.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Mayo Hospital; 🇵🇰 Lahore, Punjab, Pakistan