Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2026-01-25 @ 8:17 AM
Study NCT ID:
NCT07239206
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-26
First Post:
2025-11-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serious Game for Improving Targeted Temperature Management Knowledge and Situational Awareness in Critical Care Nurses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006323', 'term': 'Heart Arrest'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants are blinded to group assignment until the intervention begins. Investigators are aware of allocation to deliver the assigned teaching method.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomly assigned into two parallel groups. The experimental group will receive lecture-based teaching combined with a digital serious game intervention, while the control group will receive lecture-based teaching with case discussion only. Randomization will be performed at the beginning of each class session to ensure balanced group allocation.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2025-11-16', 'studyFirstSubmitQcDate': '2025-11-16', 'lastUpdatePostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Targeted Temperature Management (TTM) Knowledge Score', 'timeFrame': 'Baseline (pre-test), 1 week after intervention, and 6 weeks after intervention', 'description': 'TTM knowledge will be assessed using a validated 16-item multiple-choice questionnaire developed based on current clinical guidelines. Scores range from 0 to 100, with higher scores indicating greater knowledge of targeted temperature management principles and nursing care.'}, {'measure': 'Change in Situational Awareness (SA) Score', 'timeFrame': 'Baseline, 1 week after intervention, and 6 weeks after intervention', 'description': 'Situational awareness will be measured using a 11-item Likert scale (1-5) questionnaire assessing perception, comprehension, and projection dimensions. Total scores range from 12 to 60, with higher scores indicating greater situational awareness in clinical TTM scenarios.'}, {'measure': 'System Usability Scale (SUS) Score', 'timeFrame': '1 week after intervention (experimental group only)', 'description': 'The usability of the serious game will be evaluated using the 10-item System Usability Scale (SUS). Scores range from 0 to 100, with higher scores indicating better system usability and learner satisfaction.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Targeted temperature management', 'Serious game'], 'conditions': ['Targeted Temperature Management', 'Nursing Education', 'Serious Game', 'Cardiac Arrest']}, 'referencesModule': {'references': [{'pmid': '12847056', 'type': 'BACKGROUND', 'citation': 'Nolan JP, Morley PT, Vanden Hoek TL, Hickey RW, Kloeck WG, Billi J, Bottiger BW, Morley PT, Nolan JP, Okada K, Reyes C, Shuster M, Steen PA, Weil MH, Wenzel V, Hickey RW, Carli P, Vanden Hoek TL, Atkins D; International Liaison Committee on Resuscitation. Therapeutic hypothermia after cardiac arrest: an advisory statement by the advanced life support task force of the International Liaison Committee on Resuscitation. Circulation. 2003 Jul 8;108(1):118-21. doi: 10.1161/01.CIR.0000079019.02601.90. No abstract available.'}, {'pmid': '29457760', 'type': 'BACKGROUND', 'citation': 'Gorbanev I, Agudelo-Londono S, Gonzalez RA, Cortes A, Pomares A, Delgadillo V, Yepes FJ, Munoz O. A systematic review of serious games in medical education: quality of evidence and pedagogical strategy. Med Educ Online. 2018 Dec;23(1):1438718. doi: 10.1080/10872981.2018.1438718.'}, {'pmid': '33765189', 'type': 'BACKGROUND', 'citation': 'Nolan JP, Sandroni C, Bottiger BW, Cariou A, Cronberg T, Friberg H, Genbrugge C, Haywood K, Lilja G, Moulaert VRM, Nikolaou N, Olasveengen TM, Skrifvars MB, Taccone F, Soar J. European Resuscitation Council and European Society of Intensive Care Medicine guidelines 2021: post-resuscitation care. Intensive Care Med. 2021 Apr;47(4):369-421. doi: 10.1007/s00134-021-06368-4. Epub 2021 Mar 25.'}]}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial aims to evaluate the effectiveness of a serious game in improving targeted temperature management (TTM) knowledge and situational awareness among critical care nurses. A total of 120 nurses from adult intensive care units will be randomly assigned to either a control group receiving traditional lecture-based teaching or an experimental group receiving lecture-based teaching combined with a digital serious game. Outcomes will be measured using a TTM knowledge test, a situational awareness scale, and a system usability scale. The findings will provide evidence for the use of serious games as an innovative educational strategy to enhance post-resuscitation care quality and patient safety.', 'detailedDescription': "Targeted temperature management (TTM) is an evidence-based neuroprotective strategy recommended for patients resuscitated after cardiac arrest. Despite its clinical importance, critical care nurses often lack sufficient knowledge and situational awareness to effectively implement TTM, due to limited exposure to relevant cases and time constraints in training. Conventional teaching methods, while beneficial, face challenges such as limited resources, time, and opportunities for repeated practice.\n\nSerious games, which integrate educational content with interactive digital game elements, offer a flexible and engaging learning tool that enables repeated practice in a safe, simulated environment. Previous studies have shown that serious games can enhance learners' motivation, knowledge retention, and decision-making skills.\n\nThis study will develop and implement a serious game specifically designed for TTM education. The randomized controlled trial will enroll 120 intensive care unit nurses, randomly allocated into two groups: the control group will receive lecture-based teaching with case discussion, while the experimental group will receive the same content supplemented with the serious game for additional practice. All participants will complete a pre-test, a post-test one week after the intervention, and a follow-up test at six weeks.\n\nThe primary outcome will be the improvement in TTM knowledge, and secondary outcomes will include situational awareness and system usability (experimental group only). The study is expected to provide evidence that serious games are an effective and scalable strategy for enhancing TTM-related knowledge and situational awareness, thereby supporting better quality of post-resuscitation care and patient safety."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Registered nurses currently working in adult intensive care units (medical, surgical, or mixed ICUs).\n* Able to read and understand Chinese.\n* Willing to participate and provide informed consent.\n* Available to complete pre-test, post-test, and follow-up assessments.\n\nExclusion Criteria:\n\n* Nurses working in pediatric or neonatal ICUs.\n* Nurses holding administrative or supervisory positions (non-clinical).\n* Nurses currently participating in other TTM-related educational or research programs.\n* Individuals unable to complete the intervention or evaluation schedule.'}, 'identificationModule': {'nctId': 'NCT07239206', 'briefTitle': 'Serious Game for Improving Targeted Temperature Management Knowledge and Situational Awareness in Critical Care Nurses', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Effectiveness of Serious Game on Facilitating Targeted Temperature Management Knowledge and Situational Awareness Among Critical Care Nurses', 'orgStudyIdInfo': {'id': '202507084RINA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Serious Game + Lecture', 'description': 'Participants in this arm will receive lecture-based teaching combined with a digital serious game designed to enhance targeted temperature management (TTM) knowledge and situational awareness. The serious game includes interactive case scenarios, decision-making tasks, and real-time feedback to simulate ICU situations and reinforce learning.', 'interventionNames': ['Behavioral: Serious Game Intervention', 'Behavioral: Lecture-based Education']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active Comparator: Lecture Only', 'description': 'Participants in this arm will receive lecture-based teaching with case discussion only, covering the same targeted temperature management (TTM) content as the experimental group. No serious game intervention will be provided.', 'interventionNames': ['Behavioral: Lecture-based Education']}], 'interventions': [{'name': 'Serious Game Intervention', 'type': 'BEHAVIORAL', 'description': 'A digital serious game designed to train critical care nurses in targeted temperature management (TTM). The game features case-based simulations, interactive decision-making, and real-time feedback to improve clinical reasoning and situational awareness.', 'armGroupLabels': ['Experimental: Serious Game + Lecture']}, {'name': 'Lecture-based Education', 'type': 'BEHAVIORAL', 'description': 'Standard lecture-based teaching covering the principles, procedures, and nursing care of targeted temperature management (TTM). Participants in this group do not receive the serious game component.', 'armGroupLabels': ['Active Comparator: Lecture Only', 'Experimental: Serious Game + Lecture']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'HUI-YI LI', 'role': 'CONTACT', 'email': 'bicky05@ntuh.gov.tw', 'phone': '0920867591'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Clinical Trial Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'National Taiwan University Hospital', 'investigatorFullName': 'National Taiwan University Clinical Trial Center', 'investigatorAffiliation': 'National Taiwan University Hospital'}}}}