Impact of Counselling and Visual Aid on Anxiety in Endoscopic Patients

NCT05241158 | Completed

• 1 other identifier: 179/RC/KEMU
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Liver Disease; Inflammatory Bowel Diseases

Keywords

Endoscopy; Visual Aid; Anxiety; Counselling

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• fear

  90 minutes

• Stress

  90 minutes

Study Arms (2)

Group A

ACTIVE COMPARATOR

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.

Behavioral: Counselling

Group B

ACTIVE COMPARATOR

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.

Behavioral: Counselling with visual aid

Interventions

Counselling with visual aid BEHAVIORAL

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

Group B

Counselling BEHAVIORAL

Patients counselled about the procedure, complications and the post-procedure recovery phase

Group A

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• King Edward Medical University: lead

Study Sites (1)

Mayo Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (1)

• Khan AA, Ali A, Khan AS, Shafi Y, Masud M, Irfan F, Abaidullah S. Effects of visual aid on state anxiety, fear and stress level in patients undergoing endoscopy: a randomized controlled trial. Ann Med. 2023 Dec;55(1):1234-1243. doi: 10.1080/07853890.2023.2191000.

  PMID: 37078544 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Anxiety Disorders

Interventions

Counseling; Audiovisual Aids

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Educational Technology; Technology; Technology, Industry, and Agriculture

Study Officials

• Ali Asad Khan, FCPS

  King Edward Medical University

  PRINCIPAL INVESTIGATOR

• Anam Ali, MS

  University of Child Health Sciences & The Children's Hospital, Lahore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 5, 2022
• First Posted: February 15, 2022
• Study Start: August 16, 2018
• Primary Completion: February 4, 2020
• Study Completion: February 4, 2020
• Last Updated: November 18, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)