Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-25 @ 5:25 PM
Study NCT ID:
NCT07175103
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-16
First Post:
2025-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
RCT to Evaluate the Efficacy of the NSSCEP in Reducing Burnout Among Jordanian Pediatric Oncology Nurses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077062', 'term': 'Burnout, Psychological'}, {'id': 'D000073397', 'term': 'Occupational Stress'}], 'ancestors': [{'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D009784', 'term': 'Occupational Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-08-22', 'size': 1889088, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-08-25T18:13', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-11', 'studyFirstSubmitDate': '2025-08-26', 'studyFirstSubmitQcDate': '2025-09-11', 'lastUpdatePostDateStruct': {'date': '2025-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in Burnout Symptoms, improve Job satisfaction and missed nursing care', 'timeFrame': 'Pre-intervention (baseline) and post-intervention (at 4 weeks, following completion of the educational sessions).', 'description': "This study evaluates the Nurses' Stress Self-Care Educational Program (NSSCEP) for Jordanian pediatric oncology nurses. The four-week program includes workshops on stress management, mindfulness, and coping strategies to reduce burnout and enhance well-being. Burnout, job satisfaction, and missed nursing care are assessed using validated tools: Professional Quality of Life Scale, Nurse Job Satisfaction Scale, and MISSCARE Survey. Higher scores indicate better outcomes. The study aims to support nurse mental health and improve care quality in Jordanian hospitals."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Paediatric Oncology', 'Nurses', 'Burnout', 'Occupational Stress', 'Self Care']}, 'referencesModule': {'references': [{'pmid': '35079601', 'type': 'BACKGROUND', 'citation': 'Wei H. The development of an evidence-informed Convergent Care Theory: Working together to achieve optimal health outcomes. Int J Nurs Sci. 2021 Dec 21;9(1):11-25. doi: 10.1016/j.ijnss.2021.12.009. eCollection 2022 Jan.'}, {'pmid': '33575453', 'type': 'BACKGROUND', 'citation': 'Wei H, Hardin SR, Watson J. A unitary caring science resilience-building model: Unifying the human caring theory and research-informed psychology and neuroscience evidence. Int J Nurs Sci. 2020 Nov 24;8(1):130-135. doi: 10.1016/j.ijnss.2020.11.003. eCollection 2021 Jan 10.'}, {'pmid': '32236429', 'type': 'BACKGROUND', 'citation': 'Wei H, Kifner H, Dawes ME, Wei TL, Boyd JM. Self-care Strategies to Combat Burnout Among Pediatric Critical Care Nurses and Physicians. Crit Care Nurse. 2020 Apr 1;40(2):44-53. doi: 10.4037/ccn2020621.'}]}, 'descriptionModule': {'briefSummary': "The goal of this clinical trial is to learn if the Nurses' Stress Self-Care Educational Program (NSSCEP) can reduce burnout and occupational stress in Jordanian pediatric oncology nurses. The main questions it aims to answer are:\n\n1. Does NSSCEP reduce symptoms of burnout in pediatric oncology nurses?\n2. Does NSSCEP improve stress management skills among pediatric oncology nurses? Researchers will compare nurses participating in the NSSCEP to a control group receiving a general technical skills program to see if NSSCEP reduces burnout and improves stress management.\n\nParticipants will:\n\n1. Attend four educational sessions over one month, focusing on stress recognition, coping strategies, and resilience-building techniques\n2. Complete weekly checklists to track their application of stress management skills\n3. Participate in pre- and post-intervention surveys to assess burnout and stress levels", 'detailedDescription': "Burnout and occupational stress are significant challenges for pediatric oncology nurses in Jordan, who face intense emotional and professional demands while caring for critically ill children. The Nurses' Stress Self-Care Educational Program (NSSCEP) is designed to address this issue by equipping nurses with practical self-care strategies to enhance resilience and well-being. This study aims to evaluate the effectiveness of the NSSCEP in reducing burnout and stress levels among Jordanian pediatric oncology nurses working in hospital settings.\n\nThe NSSCEP is a structured, four-session educational intervention delivered over several weeks. Each session focuses on evidence-based self-care techniques, including stress management, mindfulness, emotional regulation, and coping strategies tailored to the unique challenges of pediatric oncology nursing. The program is facilitated by trained professionals and includes interactive workshops, group discussions, and practical exercises to foster skill development. The study compares the NSSCEP intervention group to a control group receiving standard workplace support to assess its impact on nurse well-being.\n\nThis trial addresses a critical gap in workplace interventions for Jordanian nurses, where cultural and systemic factors may influence stress and burnout. By implementing the NSSCEP, the study seeks to provide a scalable model for supporting nurse mental health in high-stress specialties. The findings may inform hospital policies and future interventions to promote sustainable nursing practice in Jordan and similar settings."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. A registered nurse (RN) employed in a paediatric oncology unit in for at least 6 months.\n2. Willingness to participate in all aspects of the study, including interventions, questionnaires, and follow-up assessments.\n3. Ability to understand and communicate in English\n4. Have ability Self-reported experience of burnout related to their role as a paediatric oncology nurse.\n5. Nurses provide informed consent\n\nExclusion Criteria:\n\n1. Less than six months of experience in paediatric oncology\n2. Non-registered nurses (e.g., nursing assistants or technicians)\n3. Non-voluntary participation or inability to provide informed consent\n4. Inability to communicate in English\n5. Involvement in leadership roles or administrative positions'}, 'identificationModule': {'nctId': 'NCT07175103', 'acronym': 'NSSCEP', 'briefTitle': 'RCT to Evaluate the Efficacy of the NSSCEP in Reducing Burnout Among Jordanian Pediatric Oncology Nurses', 'organization': {'class': 'OTHER', 'fullName': 'Universiti Putra Malaysia'}, 'officialTitle': "Nurses' Self-Care Educational Programme (NSSCEP)", 'orgStudyIdInfo': {'id': '10/2025/10411'}, 'secondaryIdInfos': [{'id': 'Prof Soh Kim Lam', 'type': 'OTHER', 'domain': 'Universiti Putra Malaysia'}, {'id': 'Dr. Faiq Algbour', 'type': 'OTHER', 'domain': 'Essra Hospital'}, {'id': 'IRB-JUH', 'type': 'OTHER', 'domain': 'Jordan Unversity Hosptal'}, {'id': 'IRB', 'type': 'OTHER', 'domain': 'Al Abdali Hospital'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stress Self-Care Education Group', 'description': "Participants in this arm will receive the Nurses' Stress Self-Care Educational Program (NSSCEP), consisting of four educational sessions over one month focused on stress recognition, coping strategies, and resilience-building techniques. Participants will also complete weekly checklists and pre- and post-intervention surveys to assess burnout and stress levels.", 'interventionNames': ["Behavioral: Nurses' Stress Self-Care Educational Program (NSSCEP)"]}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Technical Skills Education Group', 'description': 'Participants in this arm will receive a general technical skills program unrelated to stress management, delivered over one month in four sessions. Participants will also complete weekly checklists and pre- and post-intervention surveys to assess burnout and stress levels.', 'interventionNames': ['Other: General Technical Skills Program']}], 'interventions': [{'name': "Nurses' Stress Self-Care Educational Program (NSSCEP)", 'type': 'BEHAVIORAL', 'description': 'A control intervention consisting of four 1-hour sessions over one month, focusing on general technical skills relevant to pediatric oncology nursing (e.g., procedural updates, equipment use). The program does not include stress management content. Participants complete weekly checklists and pre- and post-intervention surveys to measure burnout and stress levels.', 'armGroupLabels': ['Stress Self-Care Education Group']}, {'name': 'General Technical Skills Program', 'type': 'OTHER', 'description': 'A control program with four 1-hour sessions over one month, focusing on technical skills (e.g., procedural updates, equipment use) without stress management content. Includes weekly checklists and pre/post surveys to measure burnout and stress.', 'armGroupLabels': ['Technical Skills Education Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11141', 'city': 'Amman', 'country': 'Jordan', 'facility': 'Prince Hamza Hospital', 'geoPoint': {'lat': 31.95522, 'lon': 35.94503}}], 'centralContacts': [{'name': 'FADI MY ABUSUQAIR, Dr', 'role': 'CONTACT', 'email': 'abusuqair@gmail.com', 'phone': '+962780462337'}], 'overallOfficials': [{'name': 'Soh K Lam, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universiti Putra Malaysia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universiti Putra Malaysia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'UNIVERSITI PUTRA MALAYSIA / Faculty of Medical and Health Science / Serdang', 'investigatorFullName': 'Fadi Musa Yousef Abu Suqair', 'investigatorAffiliation': 'Universiti Putra Malaysia'}}}}