HealthyNCT07491757
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
A study testing Nursing Intervention in people with Healthy, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Nursing Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Nov 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 26 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be a fourth-year student in the School of Nursing at Selçuk University
- Have successfully completed the Pediatric Nursing course
- Participate in all training sessions on fluid and electrolyte management for children trapped under rubble
- Volunteer to participate in the study
Who cannot join
- Failing to attend 10% of the training sessions for students in the startup groups
- Requesting to withdraw from the program at any stage
Trial locations and contacts
1 site in 1 country.
About this study
Official 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: Randomized Controlled Trial
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.
Read the detailed description
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.
It 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.
This 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.
Data 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.
- Conditions
- Healthy
- Being tested
- Nursing Intervention
- Keywords
- Water-Electrolyte Balance, Health Education, Nursing intervention
- Medical subject headings
- Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nursing InterventionOther
Also called classical education group
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.
nursing interventionOther
Also called simulation
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,
| Study group | Role | What they receive |
|---|---|---|
| Classical education group | Experimental | Not described Receives: Other: Nursing Intervention |
| Simulation training group | Experimental | Not described Receives: Other: nursing intervention |
| Control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: At the end of 4 week.
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.
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.
Measured: At the end of 4 week.
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.
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.
Measured: At the end of 4 week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start30 Nov 2025
- Primary completion10 Dec 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevil Özkan, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07491757
- Sponsor's protocol ID
- 2025/108
- Status last verified
- Mar 2026
- First submitted
- 13 Mar 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07491757
- Acronym / sponsor ID
- 2025/108
- Conditions
- Healthy
- Keywords
- Water-Electrolyte Balance, Health Education, Nursing intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 30 Nov 2025 (actual)
- Primary completion
- 10 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
It 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.
This 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.
Data 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Classical education group | Experimental | Other: Nursing Intervention |
| Simulation training group | Experimental | Other: nursing intervention |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 20 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Be a fourth-year student in the School of Nursing at Selçuk University
- Have successfully completed the Pediatric Nursing course
- Participate in all training sessions on fluid and electrolyte management for children trapped under rubble
- Volunteer to participate in the study
Key exclusion criteria (2 listed)
- Failing to attend 10% of the training sessions for students in the startup groups
- Requesting to withdraw from the program at any stage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nursing InterventionAlso: classical education groupIt 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. | Other | Classical education group |
| nursing interventionAlso: simulationIt 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, | Other | Simulation training group |
Primary outcome
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.
Time frame: At the end of 4 week.
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.
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.
Time frame: At the end of 4 week.
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.
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.
Time frame: At the end of 4 week.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nursing Intervention in people with Healthy, run by Selcuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: At the end of 4 week.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.