Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2025-12-26 @ 7:55 AM
Study NCT ID:
NCT07248592
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-25
First Post:
2025-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Empathy Training and Its Effect on Maternity Nurses' Communication Skills
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017060', 'term': 'Patient Satisfaction'}], 'ancestors': [{'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This study employs a single-group pre-test/post-test design. One cohort of maternity nurses will receive the intervention. Outcomes are measured at baseline (pre-test) before the training begins and then again after the training is complete (post-test). The primary analysis will compare the outcomes from these two time points to assess the effect of the training.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2025-11-18', 'studyFirstSubmitQcDate': '2025-11-18', 'lastUpdatePostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Maternity Nurses' Empathy and Communication skills", 'timeFrame': 'one week after ending sessions of training', 'description': 'Empathy level among maternity nurses, measured using the Toronto Empathy Questionnaire (TEQ). The total score ranges from 0 to 64, with a higher score indicating greater empathy.'}], 'secondaryOutcomes': [{'measure': "Parturient Women Perception of Maternity Nurses' Empathic Care", 'timeFrame': 'one week after ending sessions of training', 'description': "Parturient women's perception of nurses' empathic care, measured using the Consultation and Relational Empathy (CARE) Measure. The total score ranges from 10 to 50, with a higher score indicating better perceived empathy."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Maternity nurses', 'empathetic communication skills', 'women perception', 'Parturient women'], 'conditions': ['Communication Skills', 'Patient Satisfaction']}, 'descriptionModule': {'briefSummary': "The goal of this clinical trial is to evaluate the effectiveness of empathy skills training on Maternity Nurses' Communication and Parturient Women's Perception of Empathetic Care.\n\nThe main questions it aims to answer are;\n\n* Do maternity nurses who received empathy skills training have better empathetic communication skills when caring with parturient women than those who don't.?\n* Do parturient women who received care from maternity nurses trained with empathy skills training perceive higher empathy level than mothers who received care from untrained nurses?\n\nParticipants will:\n\n* Have 3 educational training sessions on empathy communication skills.\n* Will be followed by the researcher for any clarifications about the educational content of session\n* nurses will be asked to evaluate their empathy communication skills twice (once before training and second time after training) .\n\nalso parturient women will be asked to assess their maternity nurses' empathy care level twice (once before training and second time after training).", 'detailedDescription': "Empathy is one of the elements that influence compassionate skills which required for building a meaningful relationship between maternity nurse and the patient requires. Empathy is particularly important to maternity nurse and allows them to understand things from a woman's angle. Indeed, nurses with high-empathy are able to comprehend the feelings of women, which are very beneficial, particularly during some stages of childbirth when women may not want to talk or in situations where verbal communication is not possible. However, providing effective and empathic communication between maternity nurse and mothers increases satisfaction and control over delivery and reduces blood pressure, anxiety, pain, and fear of childbirth.\n\nThis study used a quasi-experimental (one group pre/posttest) . it will be conducted at three health settings at Mansoura city, Egypt and will involve 45 maternity nurses and 120 parturient women. Maternity nurses will be trained on empathic communication skills."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be currently employed in a maternity care setting Labor \\& Delivery Unit.\n* Have direct patient contact with parturient women as a primary part of their regular duties.\n* Have a minimum of 6 months of experience.\n\nExclusion Criteria:\n\n* Nurses whose primary role is administrative, managerial without direct patient care responsibilities.\n* Have previously participated in a pilot or feasibility study for the same or a highly similar intervention.\n* Planned absence (e.g., extended leave, vacation) for a significant portion of the study intervention or data collection period.'}, 'identificationModule': {'nctId': 'NCT07248592', 'briefTitle': "Empathy Training and Its Effect on Maternity Nurses' Communication Skills", 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': "Empathy Training: Its Effect on Maternity Nurses' Communication and Parturient Women's Perception of Empathetic Care", 'orgStudyIdInfo': {'id': '0593'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Empathy and Communication Skills Training Arm', 'description': 'This arm consists of all enrolled study participants, who are qualified maternity nurses working in the labor and delivery unit at Mansoura University Hospitals .', 'interventionNames': ['Other: Maternity Nurse Empathy and Communication Skills Training Program']}], 'interventions': [{'name': 'Maternity Nurse Empathy and Communication Skills Training Program', 'type': 'OTHER', 'otherNames': ['MNECS Training Program'], 'description': 'All participants in this single arm will receive the structured MNECS Training Program. This is a multi-session, interactive workshop designed to enhance empathy and patient-centered communication.', 'armGroupLabels': ['Empathy and Communication Skills Training Arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Al Mansurah', 'state': 'Dakahlia Governorate', 'country': 'Egypt', 'facility': 'Mansoura University', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'centralContacts': [{'name': 'Nadia Y AbdElla, Assis. prof', 'role': 'CONTACT', 'email': 'drnadiaabdella@gmail.com', 'phone': '2733200', 'phoneExt': '50'}], 'overallOfficials': [{'name': 'Nadia Y AbdElla, Assis. prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mansoura University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The reason for not sharing data is to comply with and protect the confidentiality of participants, which is a primary ethical requirement in research.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor', 'investigatorFullName': 'Nadia Youssef Ahmed AbdElla', 'investigatorAffiliation': 'Mansoura University'}}}}