Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2026-01-01 @ 6:18 PM
Study NCT ID:
NCT05241158
Status:
COMPLETED
Last Update Posted:
2022-11-18
First Post:
2022-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Counselling and Visual Aid on Anxiety in Endoscopic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003376', 'term': 'Counseling'}, {'id': 'D001296', 'term': 'Audiovisual Aids'}], 'ancestors': [{'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D018961', 'term': 'Educational Technology'}, {'id': 'D013672', 'term': 'Technology'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': '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.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "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."}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2020-02-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-16', 'studyFirstSubmitDate': '2022-02-05', 'studyFirstSubmitQcDate': '2022-02-05', 'lastUpdatePostDateStruct': {'date': '2022-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anxiety', 'timeFrame': '90 minutes', '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.'}], 'secondaryOutcomes': [{'measure': 'fear', 'timeFrame': '90 minutes', '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.'}, {'measure': 'Stress', 'timeFrame': '90 minutes', '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Endoscopy', 'Visual Aid', 'Anxiety', 'Counselling'], 'conditions': ['Chronic Liver Disease', 'Inflammatory Bowel Diseases']}, 'referencesModule': {'references': [{'pmid': '37078544', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nDepression 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* both genders (male or female) with a minimum age of 18 years\n* Able to comprehend questions being asked in Urdu language\n* Mentally competent at signing the consent form\n\nExclusion Criteria:\n\n* Patients who were diagnosed cases of psychiatric illnesses\n* Undergoing emergency endoscopy (whether diagnostic or therapeutic)\n* End stage renal disease\n* Hearing difficulty\n* Senile dementia\n* Pregnant or diagnosed cases of malignancy\n* Signs of hepatic encephalopathy'}, 'identificationModule': {'nctId': 'NCT05241158', 'briefTitle': 'Impact of Counselling and Visual Aid on Anxiety in Endoscopic Patients', 'organization': {'class': 'OTHER', 'fullName': 'King Edward Medical University'}, 'officialTitle': 'State Anxiety Level in Patients Undergoing Upper Gastrointestinal Endoscopy', 'orgStudyIdInfo': {'id': '179/RC/KEMU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A', '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.', 'interventionNames': ['Behavioral: Counselling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', '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.', 'interventionNames': ['Behavioral: Counselling with visual aid']}], 'interventions': [{'name': 'Counselling with visual aid', 'type': 'BEHAVIORAL', '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', 'armGroupLabels': ['Group B']}, {'name': 'Counselling', 'type': 'BEHAVIORAL', 'description': 'Patients counselled about the procedure, complications and the post-procedure recovery phase', 'armGroupLabels': ['Group A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Mayo Hospital', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'overallOfficials': [{'name': 'Ali Asad Khan, FCPS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'King Edward Medical University'}, {'name': 'Anam Ali, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "University of Child Health Sciences & The Children's Hospital, Lahore"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Edward Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'ali asad', 'investigatorAffiliation': 'King Edward Medical University'}}}}