Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 2:03 AM
Study NCT ID:
NCT07491757
Status:
COMPLETED
Last Update Posted:
2026-03-24
First Post:
2026-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Determining the Effects of Training on Nursing Students Using Two Different Methods for Maintaining Fluid and Electrolyte Balance in a Child Trapped Under a Collapse
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006266', 'term': 'Health Education'}], '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': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-19', 'studyFirstSubmitDate': '2026-03-13', 'studyFirstSubmitQcDate': '2026-03-19', 'lastUpdatePostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The intervention group is expected to score higher on the nursing intervention form aimed at maintaining fluid and electrolyte balance in children trapped under the rubble.', 'timeFrame': 'At the end of 4 week.', 'description': 'The scale for nursing interventions aimed at maintaining fluid and electrolyte balance in children trapped under rubble has a minimum score of 0 and a maximum score of 100. It is expected that the intervention group will score higher.'}, {'measure': 'It is expected that the intervention group will have higher levels of self-confidence on the Nursing Anxiety and Self-Confidence with Clinical Decision Making (NASC-CDM©) Scale.', 'timeFrame': 'At the end of 4 week.', 'description': 'The Nursing Anxiety and Self-Confidence with Clinical Decision Making (NASC-CDM©) Scale has a minimum score of 27 and a maximum score of 162. It is expected that the intervention group will have higher self-confidence scores.'}, {'measure': 'It is expected that the intervention group will have lower anxiety levels on the Nursing Anxiety and Self-Confidence with Clinical Decision Making (NASC-CDM©) Scale.', 'timeFrame': 'At the end of 4 week.', 'description': 'The Nursing Anxiety and Self-Confidence with Clinical Decision Making (NASC-CDM©) Scale has a minimum score of 27 and a maximum score of 162. It is expected that the intervention group will have lower anxiety scores.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Water-Electrolyte Balance', 'Health Education', 'Nursing intervention'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The aim of this randomized controlled trial is to determine the effects of two different training methods on nursing students regarding the maintenance of fluid and electrolyte balance in a child trapped under rubble. The sample consisted of 69 participants (conventional training group: 23; simulation group: 23; control group: 23). The traditional education group received training on nursing interventions related to fluid and electrolyte balance in children trapped under rubble in a single theoretical module lasting a total of 90 minutes. The simulation group, however, received the same training in two modules-combining theoretical instruction with a simulation scenario-over a total of 270 minutes. The control group received no training. Data were collected in two phases: a pre-test and a post-test; the post-tests were administered one month after the pre-test.', 'detailedDescription': "Mass disasters such as earthquakes have more severe and long-lasting biopsychosocial effects on children, whose developmental processes are ongoing and whose stress coping mechanisms are more limited compared to adults. In particular, building collapses pose a life-threatening danger to children. Crush injuries in children trapped under debris and the resulting physiological changes include disruption of fluid-electrolyte balance. Fluid-electrolyte imbalance resulting from tissue damage and Crush Syndrome can lead to life-threatening complications such as metabolic issues and acute kidney failure. Therefore, it is essential for pediatric nurses to possess the knowledge and skills necessary for caring for children in disaster conditions to ensure effective care can be maintained. This necessity highlights the importance of incorporating such knowledge and skills into the pediatric nursing undergraduate education curriculum.\n\nIt is crucial for pediatric nursing students to be adequately prepared to handle these complex and high-risk clinical situations they may encounter during disaster conditions, as this directly impacts the quality of care. However, factors such as the limited likelihood of encountering such cases in real clinical settings and the high workload and time constraints in clinical practice areas necessitate the use of alternative educational methods to help students develop their knowledge and skills. Traditional teaching methods, which are among the various approaches, are mostly teacher-centered and limited to question-and-answer sessions. For this reason, the use of simulation-based training methods has become increasingly widespread in recent years, particularly in the field of pediatric care.\n\nThis study included 69 students enrolled at the Faculty of Nursing at Selcuk University. Participants were divided into groups using sealed envelopes labeled SG, KEG, and KG. Prior to the study, the sample size for each group was calculated based on the effect size (d=0.80), power (.95), and alpha error (.05), resulting in a total of 57 participants. To prevent potential sampling issues that might arise during the study (such as participants not wishing to continue), the sample size was increased by 20%, resulting in a total of 69 nursing students (conventional education group: 23; simulation group: 23; control group: 23). The traditional education group received training on nursing interventions related to the fluid-electrolyte balance of a child trapped under debris in a single theoretical module lasting a total of 90 minutes. The simulation group, however, received the same training through both theoretical instruction and simulation scenario experience, in two modules totaling 270 minutes. The control group received no training.\n\nData were collected using an information form, a form assessing nursing students' nursing practices aimed at maintaining fluid and electrolyte balance in a child trapped under debris, and the Clinical Decision-Making Confidence and Anxiety Scale in Nursing. Validity and reliability studies for these scales were conducted on the Turkish population."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '26 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be a fourth-year student in the School of Nursing at Selçuk University\n* Have successfully completed the Pediatric Nursing course\n* Participate in all training sessions on fluid and electrolyte management for children trapped under rubble\n* Volunteer to participate in the study\n\nExclusion Criteria:\n\n* Failing to attend 10% of the training sessions for students in the startup groups\n* Requesting to withdraw from the program at any stage'}, 'identificationModule': {'nctId': 'NCT07491757', 'briefTitle': 'Determining the Effects of Training on Nursing Students Using Two Different Methods for Maintaining Fluid and Electrolyte Balance in a Child Trapped Under a Collapse', 'organization': {'class': 'OTHER', 'fullName': 'Selcuk University'}, 'officialTitle': 'Determining the Effects of Training on Nursing Students Using Two Different Methods for Maintaining Fluid and Electrolyte Balance in a Child Trapped Under a Collapse: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2025/108'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Classical education group', 'interventionNames': ['Other: Nursing Intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Simulation training group', 'interventionNames': ['Other: nursing intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'No training was provided to the students in this group during the research process. After the analyses were completed, the training materials were also provided to this group in accordance with ethical principles.'}], 'interventions': [{'name': 'Nursing Intervention', 'type': 'OTHER', 'otherNames': ['classical education group'], 'description': 'It consisted of a single module and three training topics (fluid and electrolyte balance in children, crush syndrome in children trapped under debris, and the role and responsibilities of pediatric nurses in emergency situations such as earthquakes and floods). The training was delivered by the researcher, with each topic lasting 30 minutes for a total duration of 90 minutes.', 'armGroupLabels': ['Classical education group']}, {'name': 'nursing intervention', 'type': 'OTHER', 'otherNames': ['simulation'], 'description': 'It consists of two modules. The first module covers the same topics as the traditional training group. The second module covers the use of simulation in healthcare (30 min), a simulation-based training scenario involving an 8-year-old girl trapped under rubble, and case analysis. Regarding the use of simulation in healthcare, information was provided on the history of simulation, examples of simulation-based training in nursing and pediatric nursing, and the implementation plan for simulation-based training. Subsequently, the simulation case was introduced, and students participating in the simulation-based training were assigned seat numbers. A simple computer-generated random number table was used for randomization, and groups of three were selected in this manner. After the groups were determined, the students were taken to the simulation room. Information was provided about the case, the materials to be used, and the environment, and questions were answered. Following this stage,', 'armGroupLabels': ['Simulation training group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Konya', 'country': 'Turkey (Türkiye)', 'facility': 'Selçuk University', 'geoPoint': {'lat': 37.87135, 'lon': 32.48464}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Selcuk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Sevil Özkan', 'investigatorAffiliation': 'Selcuk University'}}}}