Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-01-05 @ 12:41 AM
Study NCT ID:
NCT06514404
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-23
First Post:
2024-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Study of Empathy and Anxiety in the Different Academic Years, at the Beginning of Academic Year and Exam Period in Healthy Students.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006266', 'term': 'Health Education'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D000099060', 'term': 'Adherence Interventions'}, {'id': 'D055118', 'term': 'Medication Adherence'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 65}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-09-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-17', 'studyFirstSubmitDate': '2024-07-17', 'studyFirstSubmitQcDate': '2024-07-17', 'lastUpdatePostDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Empathy Quotent', 'timeFrame': 'Through study completion, an average of 1 week', 'description': 'It consists of 60 items, 40 measuring empathy and 20 control measures. Scores range from 0 to 80. It measures cognitive and affective empathy in adults. Equalizer allows classification into four categories, which facilitates comparison between groups. The cut-off for each level is: from 0 to 32 scores: low empathy (average scores in Asperger Syndrome is 20), from 33 to 52 scores: average empathy (average in men 42, average in women 47), from 53 to 63 scores: above average, from 64 to 80 scores: high empathy'}, {'measure': 'State anxiety', 'timeFrame': 'Through study completion, an average of 1 week', 'description': 'The response scale is Likert-type with 4 alternatives (in the Spanish adaptation from 0 to 3). There are 20 items for evaluation. Thus, the range of responses goes from 0 to 60, with a higher level of anxiety corresponding to a higher score.'}, {'measure': 'Anxiety as a trait', 'timeFrame': 'Through study completion, an average of 1 week', 'description': 'The response scale is Likert-type with 4 alternatives (in the Spanish adaptation from 0 to 3). Trait anxiety has 20 items for its evaluation. Thus, the range of responses goes from 0 to 60, with a higher level of anxiety corresponding to a higher score.'}, {'measure': 'Abbreviated personality questionnaire', 'timeFrame': 'Through study completion, an average of 1 week', 'description': 'The EPQR-A is an abbreviated form of the Eysenck Personality Questionnaire. It is a 24-item self-report measure that leverages three personality scales (extraversion, neuroticism and psychoticism) and a lie validity scale. Each scale is assessed by 6 questions that participants rate on a binary frequency scale scored 1 or 0.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['health students', 'anxiety', 'empahty', 'assessment personality', 'Health behavior'], 'conditions': ['Health Education', 'Health Promotion', 'Health Behavior']}, 'descriptionModule': {'briefSummary': 'Students from different health science degrees will carry out a study on the variables of empathy, anxiety and personality profile.', 'detailedDescription': 'Students from different health science degrees will carry out a study on the variables of empathy, anxiety and personality profile by means of validated questionnaires in order to compare them between different Spanish regions and in different courses to be able to see their evolution and characteristics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Health science students are the target population of this study and the aim is to obtain data on their state and trait anxiety as well as its relationship with personality at the beginning of the academic year.', 'genderDescription': 'we will compare the students by sex', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women who are studying a health grade.\n* Subjects that wish to participate in the study.\n\nExclusion Criteria:\n\n* Students who do not wish to participate in the study.'}, 'identificationModule': {'nctId': 'NCT06514404', 'briefTitle': 'Comparative Study of Empathy and Anxiety in the Different Academic Years, at the Beginning of Academic Year and Exam Period in Healthy Students.', 'organization': {'class': 'OTHER', 'fullName': 'Mayuben Private Clinic'}, 'officialTitle': 'Comparative Study of Empathy and Anxiety in the Different Academic Years, at the Beginning of Academic Year and Exam Period and the Relationship of These Variables With Personality at the University of León and Madrid in the Degree of Nursing, Physiotherapy and Podiatry.', 'orgStudyIdInfo': {'id': 'C.I. 23/792-E'}}, 'armsInterventionsModule': {'interventions': [{'name': 'observational study', 'type': 'OTHER', 'description': 'Observational study of the effects on anxiety and empathy of personality the situation of start academic year in health sciences'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Eva María Martínez-Jiménez, PhD', 'role': 'CONTACT', 'email': 'evamam03@ucm.es', 'phone': '913941498'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayuben Private Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Profesor', 'investigatorFullName': 'EVA MARIA MARTÍNEZ JIMENEZ', 'investigatorAffiliation': 'Universidad Complutense de Madrid'}}}}