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Impact of Counselling and Visual Aid on Anxiety in Endoscopic Patients

Primary Purpose

Chronic Liver Disease, Inflammatory Bowel Diseases

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Counselling with visual aid
Counselling
Sponsored by
King Edward Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Liver Disease focused on measuring Endoscopy, Visual Aid, Anxiety, Counselling

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group A

Group B

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
February 5, 2022
Last Updated
November 16, 2022
Sponsor
King Edward Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05241158
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
August 16, 2018 (Actual)
Primary Completion Date
February 4, 2020 (Actual)
Study Completion Date
February 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Edward Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Liver Disease, Inflammatory Bowel Diseases
Keywords
Endoscopy, Visual Aid, Anxiety, Counselling

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
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.
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Counselling with visual aid
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Counselling
Intervention Description
Patients counselled about the procedure, complications and the post-procedure recovery phase
Primary Outcome Measure Information:
Title
Anxiety
Description
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.
Time Frame
90 minutes
Secondary Outcome Measure Information:
Title
fear
Description
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.
Time Frame
90 minutes
Title
Stress
Description
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.
Time Frame
90 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Asad Khan, FCPS
Organizational Affiliation
King Edward Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anam Ali, MS
Organizational Affiliation
University of Child Health Sciences & The Children's Hospital, Lahore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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Impact of Counselling and Visual Aid on Anxiety in Endoscopic Patients

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