Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-28 @ 10:48 AM
Study NCT ID:
NCT05164068
Status:
COMPLETED
Last Update Posted:
2021-12-20
First Post:
2021-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of an Informative Anxiety and Stress in Patients Requiring an Oral Biopsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-07-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-17', 'studyFirstSubmitDate': '2021-11-22', 'studyFirstSubmitQcDate': '2021-12-17', 'lastUpdatePostDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anxiety level comparison biopsy with two preoperative information types', 'timeFrame': 'Baseline', 'description': 'Modified Dental Anxiety Scale (MDAS) was used to assess anxiety levels. The Modified Dental Anxiety Scale (MDAS) consisted of 5 questions ranging from 5 (no anxiety) to 25 (highest anxiety level). Every patient was asked to mark his or her perceived dental anxiety level on the line.'}, {'measure': 'Anxiety level comparison biopsy with two preoperative information types', 'timeFrame': '1 day of Final measure of the biopsy intervention', 'description': 'Modified Dental Anxiety Scale (MDAS) was used to assess anxiety levels. The Modified Dental Anxiety Scale (MDAS) consisted of 5 questions ranging from 5 (no anxiety) to 25 (highest anxiety level). Every patient was asked to mark his or her perceived dental anxiety level on the line.'}], 'secondaryOutcomes': [{'measure': 'Evaluate patient-reported pain levels', 'timeFrame': 'Baseline', 'description': 'The Visual Analog Scale (VAS) will be used on a 0 to 10 scale, 0 being no pain at all and 10 being the worst pain imaginable.'}, {'measure': 'Evaluate patient-reported pain levels', 'timeFrame': '1 day of final measure of the biopsy intervention', 'description': 'The Visual Analog Scale (VAS) will be used on a 0 to 10 scale, 0 being no pain at all and 10 being the worst pain imaginable.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anxiety ; Dental']}, 'referencesModule': {'references': [{'pmid': '28106507', 'type': 'BACKGROUND', 'citation': 'Lin CS, Wu SY, Yi CA. Association between Anxiety and Pain in Dental Treatment: A Systematic Review and Meta-analysis. J Dent Res. 2017 Feb;96(2):153-162. doi: 10.1177/0022034516678168. Epub 2016 Nov 16.'}, {'pmid': '29558935', 'type': 'BACKGROUND', 'citation': 'Caltabiano ML, Croker F, Page L, Sklavos A, Spiteri J, Hanrahan L, Choi R. Dental anxiety in patients attending a student dental clinic. BMC Oral Health. 2018 Mar 20;18(1):48. doi: 10.1186/s12903-018-0507-5.'}]}, 'descriptionModule': {'briefSummary': 'In clinical practice, patients scheduled for biopsy often suffer substantial stress before, during or after the procedure. In particular, most patients feel uncomfortable both with the procedure itself and with the idea of the results of the biopsy.\n\nProviding adequate information is crucial, though there is no agreement as to which is the best way to present such information. Although verbal information provided by the professional is the most common scenario, the use of written information in the form of explanatory leaflets, as well as audio recordings or videos, has also been proposed The present study was carried out at the Dental School of Universidad de San Carlos (Guatemala) to evaluate the hypothesis that an audiovisual intervention providing information on oral biopsy is able to reduce patient anxiety and stress.', 'detailedDescription': 'A prospective, randomized clinical trial was carried out involving. A total of 120 patients were therefore finally randomized, following the Consort Statement guidelines, with the definition of two groups: a control group (n = 60) that received standard verbal information, and an experimental group (n = 60) that received information in the form of a video'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The inclusion criteria were a patient age of over 18 years and the presence of an oral lesion/s requiring biopsy.\n\nExclusion Criteria:\n\n* Patients with decompensated systemic disorders, poor general condition, a history of psychiatric disease or psychoactive drug use were excluded, as were pregnant women and individuals failing to sign the informed consent document.'}, 'identificationModule': {'nctId': 'NCT05164068', 'acronym': 'Anxiety', 'briefTitle': 'Effect of an Informative Anxiety and Stress in Patients Requiring an Oral Biopsy', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Murcia'}, 'officialTitle': 'Effect of an Informative Video Upon Anxiety and Stress in Patients Requiring an Oral Biopsy', 'orgStudyIdInfo': {'id': 'adcobiusac 023-2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Information video', 'description': 'The experimental group likewise consisted of 60 individuals that received information about the biopsy procedure in video format', 'interventionNames': ['Behavioral: Information video']}, {'type': 'NO_INTERVENTION', 'label': 'Information face-to -face', 'description': 'The control group consisted of 60 patients that received face-to-face verbal information in a homogeneous and reproducible manner'}], 'interventions': [{'name': 'Information video', 'type': 'BEHAVIORAL', 'description': 'The video contents were clear and adapted to the characteristics of the population of Guatemala. The video provided a simple description of the biopsy, its risks and benefits, complications and general recommendations, and was presented preoperatively', 'armGroupLabels': ['Information video']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30008', 'city': 'Murcia', 'country': 'Spain', 'facility': 'Pia Lopez Jornet', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Murcia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Investigador principal Head Oral Medicine', 'investigatorFullName': 'Pia Lopez Jornet', 'investigatorAffiliation': 'Universidad de Murcia'}}}}