Pediatric NursingNCT06650904
Simulation Based Child and Family Communication Practice
A study testing simulation based training in people with Pediatric Nursing and Communication, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
The use of simulation-based methods in training pediatric nurses plays an important role in improving their communication skills. In this context, the aim of the research is to develop a simulation-based child and family communication training program. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Nursing, Communication, Problem Solving
- What is being tested?
- simulation based training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2024to 1 Feb 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Providing care to a pediatric patient
- Agreeing to participate in the study
Who cannot join
- Nurses who want to withdraw from the study
- Nurses who have not completed all modules
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Gazi University
Ankara, 06530
Ahu CIRLAK, PhD, RN, 05556971356, ahu-c@hotmail.com
Ebru KILICARSLAN, PhD, RN, ebrutoruner@gazi.edu.tr
About this study
Official title: The Effect of Simulation-Based Child and Family Communication Practice on Pediatric Nurses' Communication and Problem-Solving Skills
The use of simulation-based methods in training pediatric nurses plays an important role in improving their communication skills. In this context, the aim of the research is to develop a simulation-based child and family communication training program. The study aims to evaluate the effect of this communication practice on the communication and problem-solving skills of pediatric nurses. The research is designed as a quasi-experimental study. The study sample will consist of 48 nurses working in pediatric clinics. The nurses, who will receive information about the simulation laboratory, will be divided into groups of 3, and the application will be conducted using a semi-structured scenario in the simulation laboratory. The application will be recorded on video, and feedback will be provided through debriefing sessions based on these recordings. A descriptive data form, a simulation self-assessment scale, a communication skills inventory, and an adult problem-solving scale will be used for data collection. Data will be collected before the application, and at the 1st week and 1st month after the application. As a result of the research, it is aimed to adapt the simulation-based communication skills given to pediatric nurses to the clinical environment.
Questions of the study;
Read more
Pediatric nurses before and 1 week and 1 month after simulation-based child and family practice:
Is there a difference between the mean scores of the Communication Skills Inventory? Is there a difference between the mean scores of the Problem Solving Inventory?
Pediatric nurses 1 week and 1 month after simulation-based child and family practice:
Is there a difference between the mean scores of the Simulation Self-Assessment Scale?
Read the detailed description
The research is planned to be conducted as a quasi-experimental study using pre-test-post-test in order to examine the effect of simulation-based applied training for children and families on the communication and problem solving skills of pediatric nurses. The research will be conducted in the pediatric simulation laboratory of Gazi University Faculty of Nursing, Department of Pediatric Nursing. Pediatric Nursing Practice Laboratory consists of two application areas. In the first application area, there is a simulation room and a control room used by the instructors, where student practices are observed and evaluated through mirror glass. The second application area is used to evaluate the analysis phase and feedbacks of the participants' applications, which are videotaped after the simulation applications, by coming together with the participants after the application. The research sample will consist of 48 nurses who work with pediatric patients in a private hospital and agree to participate in the study. After obtaining the necessary permissions for the study, a 4-hour pre-application will be made with a different group of nurses not included in the study and all modules and forms will be applied. The necessary arrangements identified will be made before the application. Simulation application groups will be formed with groups of 3 people on a predetermined day and time according to the working days and hours of the nurses who agree to participate in the study. Before the simulation application, the pediatric simulation laboratory will be introduced to the nurses who agree to participate in the study. The orientation of the nurses to the simulation environment, the materials to be used and the characteristics of the model (expected goal, what they are asked to do, application time, evaluation) will be provided. The pre-created semi-structured scenario for the themes determined before the simulation application will be explained to the nurses. The simulation practice will last approximately 1.5 hours (40 min simulation practice + 50 min debriefing = 1.5 hours). During the implementation, the scenario will be realized with video shooting. While the researchers will manage the scenario, they will take notes on the practices of the nurses. After the simulation application, feedback will be provided to the nurses about the positive aspects and skills that need to be developed by the researchers through a debriefing interview over the video recordings. The data obtained will be evaluated using SPSS 25.0 package program. Data will be evaluated by descriptive analysis (percentage, frequency). The confidence interval will be accepted as 0.95. In the study, firstly, it will be evaluated whether the data obtained show normal distribution or not. Pre-test and post-test scale scores will be analyzed and evaluated with t-test for dependent groups. The cause and effect relationship between the scales will be analyzed by regression analysis. In the analysis of the results, the findings will be considered statistically significant if p<0.05.
- Conditions
- Pediatric Nursing, Communication, Problem Solving
- Being tested
- simulation based training
- Keywords
- pediatric nursing, communication, problem-solving, simulation
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simulation based trainingOther
Simulation practice enables the acquisition of realistic skills. Semi-structured scenarios used in the training allow nurses to demonstrate their real communication skills.
| Study group | Role | What they receive |
|---|---|---|
| Simulation-Based Child and Family Communication Application | Other | pre-test post-test design quasi-experimental study without control group Receives: Other: simulation based training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Communication Skills Inventory
The inventory used to assess an individual's own communication skills consists of 3 sub-dimensions: mental, emotional and behavioral. The first form, which was used as the "Communication Skills Assessment Scale" developed by Korkut (1996) with 70 items, was revised as the 45-item "Communication Skills Inventory" by Ersanlı and Balcı in 1998 after its validity and reliability was established. The inventory is a 5-point Likert scale. Opposite each statement, there are frequency expressions as "always (5), usually (4), sometimes (3), rarely (2), never (1)". The highest score that can be obtained from the inventory is 225 and the lowest score is 45. The total score obtained from the inventory shows the general communication skill level of the person. In addition, each sub-dimension of the inventory can be evaluated separately. A high score indicates a high level of communication skills. The cronbach alpha reliability coefficient of the scale is 0.72
Measured: up to 1 month from the beginning of training
Problem Solving Inventory
The scale developed by Heppner and Peterson (1982) is a 6-point Likert-type scale consisting of 35 items that determines the stages of the problem solving process and evaluates what individuals think about their own problem solving behaviors and approaches. The inventory consists of three dimensions: "Solving Problem Confidence", 'Approach-Avoidance Style' and 'Personal Control'. The minimum score of the inventory is 32 and the maximum score is 192. Items 9, 22 and 29 of the inventory are not included in the scoring. The Turkish validity and reliability of the inventory was conducted by Şahin, Şahin, and Heppner (1993). The usability study for nurses was conducted by Erenler (2007). A high score obtained from the inventory indicates that the individual perceives himself/herself as inadequate in problem solving skills. Cronbach alpha internal consistency of the inventory was determined as 0.90.
Measured: up to 1 month from the beginning of the training
Self-Assessment Scale for Simulation Laboratory Applications (SES-SLP)
The scale developed by Kılıcarslan Toruner et al. (2021) consists of 23 items and 2 sub-dimensions. The sub-dimensions of the scale are developmental factor (19 items) and challenging factor (4 items). The scale is 5-point Likert type. There are five options for each item in the scale: 0 = Disagree, 1 = Somewhat Agree, 2 = Undecided, 3 = Agree and 4 = Strongly Agree. Items 3, 6, 10 and 19 are reverse coded. The minimum score of the scale is 0 and the maximum score is 92. A high score indicates that the individual's perspective on professional knowledge, skills and attitudes has increased due to the practices. The cronbach alpha value of the scale is 0.94
Measured: 1 week after the start of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start1 Nov 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric NursingStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 48 nurses serving pediatric patients working in a private hospital
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Kilicarslan Toruner, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06650904
- Sponsor's protocol ID
- 2021 - 1039
- Status last verified
- Oct 2024
- First submitted
- 18 Oct 2024
- Last updated
- 21 Oct 2024
- 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 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Simulation-Based Child and Family Communication Practice on Pediatric Nurses' Communication and Problem-Solving Skills
- ClinicalTrials.gov ID
- NCT06650904
- Acronym / sponsor ID
- 2021 - 1039
- Conditions
- Pediatric Nursing, Communication, Problem Solving
- Keywords
- pediatric nursing, communication, problem-solving, simulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 21 Oct 2024 (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 use of simulation-based methods in training pediatric nurses plays an important role in improving their communication skills. In this context, the aim of the research is to develop a simulation-based child and family communication training program. The study aims to evaluate the effect of this communication practice on the communication and problem-solving skills of pediatric nurses. The research is designed as a quasi-experimental study. The study sample will consist of 48 nurses working in pediatric clinics. The nurses, who will receive information about the simulation laboratory, will be divided into groups of 3, and the application will be conducted using a semi-structured scenario in the simulation laboratory. The application will be recorded on video, and feedback will be provided through debriefing sessions based on these recordings. A descriptive data form, a simulation self-assessment scale, a communication skills inventory, and an adult problem-solving scale will be used for data collection. Data will be collected before the application, and at the 1st week and 1st month after the application. As a result of the research, it is aimed to adapt the simulation-based communication skills given to pediatric nurses to the clinical environment.
Questions of the study;
Pediatric nurses before and 1 week and 1 month after simulation-based child and family practice:
Is there a difference between the mean scores of the Communication Skills Inventory? Is there a difference between the mean scores of the Problem Solving Inventory?
Pediatric nurses 1 week and 1 month after simulation-based child and family practice:
Is there a difference between the mean scores of the Simulation Self-Assessment Scale?
Detailed description
The research is planned to be conducted as a quasi-experimental study using pre-test-post-test in order to examine the effect of simulation-based applied training for children and families on the communication and problem solving skills of pediatric nurses. The research will be conducted in the pediatric simulation laboratory of Gazi University Faculty of Nursing, Department of Pediatric Nursing. Pediatric Nursing Practice Laboratory consists of two application areas. In the first application area, there is a simulation room and a control room used by the instructors, where student practices are observed and evaluated through mirror glass. The second application area is used to evaluate the analysis phase and feedbacks of the participants' applications, which are videotaped after the simulation applications, by coming together with the participants after the application. The research sample will consist of 48 nurses who work with pediatric patients in a private hospital and agree to participate in the study. After obtaining the necessary permissions for the study, a 4-hour pre-application will be made with a different group of nurses not included in the study and all modules and forms will be applied. The necessary arrangements identified will be made before the application. Simulation application groups will be formed with groups of 3 people on a predetermined day and time according to the working days and hours of the nurses who agree to participate in the study. Before the simulation application, the pediatric simulation laboratory will be introduced to the nurses who agree to participate in the study. The orientation of the nurses to the simulation environment, the materials to be used and the characteristics of the model (expected goal, what they are asked to do, application time, evaluation) will be provided. The pre-created semi-structured scenario for the themes determined before the simulation application will be explained to the nurses. The simulation practice will last approximately 1.5 hours (40 min simulation practice + 50 min debriefing = 1.5 hours). During the implementation, the scenario will be realized with video shooting. While the researchers will manage the scenario, they will take notes on the practices of the nurses. After the simulation application, feedback will be provided to the nurses about the positive aspects and skills that need to be developed by the researchers through a debriefing interview over the video recordings. The data obtained will be evaluated using SPSS 25.0 package program. Data will be evaluated by descriptive analysis (percentage, frequency). The confidence interval will be accepted as 0.95. In the study, firstly, it will be evaluated whether the data obtained show normal distribution or not. Pre-test and post-test scale scores will be analyzed and evaluated with t-test for dependent groups. The cause and effect relationship between the scales will be analyzed by regression analysis. In the analysis of the results, the findings will be considered statistically significant if p<0.05.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 48 nurses serving pediatric patients working in a private hospital
| Arm | Type | Receives |
|---|---|---|
| Simulation-Based Child and Family Communication Application | Other | Other: simulation based trainingpre-test post-test design quasi-experimental study without control group |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Providing care to a pediatric patient
- Agreeing to participate in the study
Key exclusion criteria (2 listed)
- Nurses who want to withdraw from the study
- Nurses who have not completed all modules
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 |
|---|---|---|
| simulation based trainingSimulation practice enables the acquisition of realistic skills. Semi-structured scenarios used in the training allow nurses to demonstrate their real communication skills. | Other | Simulation-Based Child and Family Communication Application |
Primary outcome
Communication Skills Inventory
Time frame: up to 1 month from the beginning of training
The inventory used to assess an individual's own communication skills consists of 3 sub-dimensions: mental, emotional and behavioral. The first form, which was used as the "Communication Skills Assessment Scale" developed by Korkut (1996) with 70 items, was revised as the 45-item "Communication Skills Inventory" by Ersanlı and Balcı in 1998 after its validity and reliability was established. The inventory is a 5-point Likert scale. Opposite each statement, there are frequency expressions as "always (5), usually (4), sometimes (3), rarely (2), never (1)". The highest score that can be obtained from the inventory is 225 and the lowest score is 45. The total score obtained from the inventory shows the general communication skill level of the person. In addition, each sub-dimension of the inventory can be evaluated separately. A high score indicates a high level of communication skills. The cronbach alpha reliability coefficient of the scale is 0.72
Problem Solving Inventory
Time frame: up to 1 month from the beginning of the training
The scale developed by Heppner and Peterson (1982) is a 6-point Likert-type scale consisting of 35 items that determines the stages of the problem solving process and evaluates what individuals think about their own problem solving behaviors and approaches. The inventory consists of three dimensions: "Solving Problem Confidence", 'Approach-Avoidance Style' and 'Personal Control'. The minimum score of the inventory is 32 and the maximum score is 192. Items 9, 22 and 29 of the inventory are not included in the scoring. The Turkish validity and reliability of the inventory was conducted by Şahin, Şahin, and Heppner (1993). The usability study for nurses was conducted by Erenler (2007). A high score obtained from the inventory indicates that the individual perceives himself/herself as inadequate in problem solving skills. Cronbach alpha internal consistency of the inventory was determined as 0.90.
Self-Assessment Scale for Simulation Laboratory Applications (SES-SLP)
Time frame: 1 week after the start of training
The scale developed by Kılıcarslan Toruner et al. (2021) consists of 23 items and 2 sub-dimensions. The sub-dimensions of the scale are developmental factor (19 items) and challenging factor (4 items). The scale is 5-point Likert type. There are five options for each item in the scale: 0 = Disagree, 1 = Somewhat Agree, 2 = Undecided, 3 = Agree and 4 = Strongly Agree. Items 3, 6, 10 and 19 are reverse coded. The minimum score of the scale is 0 and the maximum score is 92. A high score indicates that the individual's perspective on professional knowledge, skills and attitudes has increased due to the practices. The cronbach alpha value of the scale is 0.94
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing simulation based training in people with Pediatric Nursing and Communication, run by Gazi 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 2 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: opening soon, as of the sponsor's last update on 21 Oct 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahu CIRLAK, PhD, RN (05556971356, ahu-c@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Communication Skills Inventory (time frame: up to 1 month from the beginning of training). 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 21 Oct 2024.