Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT07238205
Status:
RECRUITING
Last Update Posted:
2025-11-20
First Post:
2025-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mixed Reality Training for Teaching Cervical Effacement and Dilation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants were blinded to group allocation, and the outcomes assessor was blinded to the intervention received by each participant to prevent assessment bias.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, parallel-group controlled trial including an intervention group receiving mixed reality training and a control group receiving standard education.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-15', 'studyFirstSubmitDate': '2025-09-12', 'studyFirstSubmitQcDate': '2025-11-15', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of Cervical Dilation Measurement (cm)', 'timeFrame': '4 month', 'description': "Accuracy of cervical dilation measurement will be assessed by calculating the absolute difference (in centimeters) between the student's measurement and the researcher's reference measurement. Each participant will perform one vaginal examination on five different pregnant women. The mean absolute difference across all five assessments will be reported as the participant's cervical dilation measurement accuracy. Smaller values indicate higher accuracy."}, {'measure': 'Accuracy of Cervical Effacement Measurement (%)', 'timeFrame': '4 month', 'description': "Cervical effacement accuracy will be assessed by calculating the absolute difference (in percentage points) between the student's effacement measurement and the researcher's reference measurement. Each participant will perform one vaginal examination on five different pregnant women. The mean absolute difference across all five assessments will be reported as the participant's cervical effacement measurement accuracy. Smaller values indicate higher accuracy."}], 'secondaryOutcomes': [{'measure': 'Assessment of Cognitive Load', 'timeFrame': '4 months', 'description': 'Cognitive load will be assessed using the Cognitive Load Scale, a 9-point Likert-type measure.\n\nParticipants will respond to the question "How much mental effort did you invest in completing the task?" by selecting a score between 1 (low) and 9 (high).\n\nThe midpoint of the scale is 5; participants scoring above this value will be considered to have experienced higher levels of cognitive load.'}, {'measure': 'Assessment of Presence Experience', 'timeFrame': 'Immediately after MR training (within 1 day)', 'description': 'The sense of presence will be assessed using the Presence Scale (PS) adapted to a 5-point Likert scale. Participants will rate their virtual reality experience from 1 (strongly disagree) to 5 (strongly agree). Higher subscale scores indicate that the virtual environment is perceived as more realistic and that the sense of presence is stronger.'}, {'measure': 'Assessment of Midwifery Professional Perception', 'timeFrame': '4 months', 'description': 'Midwifery professional perception will be assessed using the Midwifery Professional Perception Scale (MPPS). Participants will rate statements reflecting their perceptions of the midwifery profession on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate a more positive perception of the midwifery profession.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cervical Dilatation', 'Labor', 'First Stage'], 'conditions': ['Labor; Poor, Primary']}, 'descriptionModule': {'briefSummary': "The aim of this educational research is to determine whether a mixed reality-based training program is effective in teaching midwifery students how to assess cervical effacement and dilation. The study also examines the impact of mixed reality on students' cognitive load, sense of presence, and midwifery professional perception.\n\nThe main questions the study seeks to answer are:\n\nDoes mixed reality training reduce students' cognitive load?\n\nDoes mixed reality increase the students' sense of presence?\n\nHow does mixed reality-based training influence students' professional perception of midwifery?\n\nDo students who receive mixed reality training perform better in assessing cervical effacement and dilation on real pregnant women compared with the control group?", 'detailedDescription': "The aim of this educational research is to determine whether a mixed reality-based training program is effective in teaching midwifery students how to assess cervical effacement and dilation. The study also examines the impact of mixed reality on students' cognitive load, sense of presence, and midwifery professional perception.\n\nThe main questions the study seeks to answer are:\n\nDoes mixed reality training reduce students' cognitive load?\n\nDoes mixed reality increase the students' sense of presence?\n\nHow does mixed reality-based training influence students' professional perception of midwifery?\n\nDo students who receive mixed reality training perform better in assessing cervical effacement and dilation on real pregnant women compared with the control group?\n\nHow the research will be conducted:\n\nResearchers will compare a mixed reality intervention group with a control group receiving traditional training. Students in both groups will evaluate five different pregnant women to assess cervical effacement and dilation in real clinical settings.\n\nParticipants will:\n\nReceive either mixed reality-based training (intervention) or traditional instruction (control)\n\nComplete the Cognitive Load Scale, Sense of Presence Scale, and Midwifery Professional Perception Scale\n\nPerform cervical effacement and dilation assessments on five pregnant women during clinical practice"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Enrolled in the Midwifery Department at Mardin Artuklu University,\n* Taking the course "Normal Birth and Postpartum Care,"\n* Who have not previously received any structured training (practical training, simulation, etc.) related to vaginal examination or cervical dilation/effacement procedures,\n* Who do not feel confident in assessing cervical effacement and dilation,\n* Who volunteer to participate in the study will be included,\n* Pregnant women who are in the first stage of labor and have no obstetric complications.\n\nExclusion Criteria:\n\n* Individuals who are graduates of health vocational high schools,\n* Have disabilities in their eyes, hands, arms, or fingers,\n* Those who do not complete the training will not be included.'}, 'identificationModule': {'nctId': 'NCT07238205', 'briefTitle': 'Mixed Reality Training for Teaching Cervical Effacement and Dilation', 'organization': {'class': 'OTHER', 'fullName': 'Mardin Artuklu University'}, 'officialTitle': 'The Effect of Mixed Reality Application in Teaching Cervical Effacement and Dilatation on Cognitive Load, Sense of Presence, and Midwifery Professional Perception', 'orgStudyIdInfo': {'id': 'MAU-Midwifery-UG-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mixed Reality Training Group', 'description': 'Students will participate in a mixed reality (MR)-based training program.', 'interventionNames': ['Other: mixed reality education']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Education Group', 'description': 'Students in the control group will receive traditional theoretical instruction.', 'interventionNames': ['Other: Standard Education Group']}], 'interventions': [{'name': 'mixed reality education', 'type': 'OTHER', 'description': 'Students will participate in a mixed reality (MR)-based training program.\n\nThe program is designed to teach cervical effacement and dilation assessment.\n\nDuring the training, students will interact with three-dimensional virtual cervical models.\n\nThey will be able to practice repeatedly in a safe, error-free environment to enhance their clinical skills.\n\nAfter completing MR training, students will perform vaginal examinations on 10 virtual patient scenarios.\n\nThe accuracy of each assessment will be automatically evaluated by the system.\n\nFollowing MR training, students will conduct vaginal examinations on five pregnant women under researcher supervision in a real clinical setting.\n\nThe following scales will be administered to participants:\n\nCognitive Load Scale\n\nSense of Presence Scale\n\nMidwifery Professional Perception Scale\n\nThese measures will be used to determine the cognitive and professional effects of MR-based learning.', 'armGroupLabels': ['Mixed Reality Training Group']}, {'name': 'Standard Education Group', 'type': 'OTHER', 'description': "Students in the control group will receive traditional theoretical instruction.\n\nThe training content will cover the principles of cervical effacement and dilation assessment.\n\nAfter completing the theoretical training, students will complete the Cognitive Load Scale and the Midwifery Professional Perception Scale.\n\nUnder researcher supervision, students will perform vaginal examinations on five pregnant women to assess cervical effacement and dilation.\n\nThese evaluations will be used to examine the effects of traditional training on students' cognitive load, professional perception, and practical assessment skills.", 'armGroupLabels': ['Standard Education Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47200', 'city': 'Mardin', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Ülkin Gündüz Aruser, Ph.D', 'role': 'CONTACT', 'email': 'ulkingunduz@artuklu.edu.tr', 'phone': '+905314592113'}], 'facility': 'Mardin Training and Research Hospital', 'geoPoint': {'lat': 37.31309, 'lon': 40.74357}}], 'centralContacts': [{'name': 'Ülkin Gündüz Aruser, Ph.D', 'role': 'CONTACT', 'email': 'ulkingunduz@artuklu.edu.tr', 'phone': '+905314592113'}, {'name': 'Hacer Ünver Koca, Assoc. Prof.', 'role': 'CONTACT', 'email': 'hacer.unver@inonu.edu.tr', 'phone': '+905446799899'}], 'overallOfficials': [{'name': 'Ülkin Gündüz Aruser, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mardin Artuklu University'}, {'name': 'Hacer Ünver Koca, Assoc. Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Inonu University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mardin Artuklu University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant', 'investigatorFullName': 'Ulkin Gündüz', 'investigatorAffiliation': 'Mardin Artuklu University'}}}}