Simulation-based LearningNCT06959875
Therapeutic Communication Training in Perinatal Loss: Simulation-Based Approaches
A study testing High-Fidelity Simulation-Based Therapeutic Communication Training and Paper-Pencil Simulation-Based Therapeutic Communication Training in people with Simulation-based Learning and Communication Skills, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effect of simulation-based education on nursing students' therapeutic communication skills in managing perinatal loss. Perinatal loss, defined as early fetal loss before 20 weeks of gestation and late fetal loss at or after 20 weeks, is a traumatic experience that significantly impacts… Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Simulation-based Learning, Communication Skills, Paper-Pencil Simulation
- What is being tested?
- High-Fidelity Simulation-Based Therapeutic Communication Training and Paper-Pencil Simulation-Based Therapeutic Communication Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2024to 30 Jan 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 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Completion of the theoretical course on postpartum care in the Women's Health and Diseases Nursing course.
- Successful completion of the Human Behavior and Communication course.
- Completion of training on perinatal grief and therapeutic communication skills prior to the simulation training.
Who cannot join
- Medical or Psychological Conditions Impacting Communication
- Incomplete Training or Lack of Pre-Simulation Education
- Inability to Participate in the Debriefing Session
- Language Barriers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Different Methods in Therapeutic Communication Training for Student Nurses in the Perinatal Loss: High-Fidelity Simulation and Paper - Pencil Simulation
This study aims to evaluate the effect of simulation-based education on nursing students' therapeutic communication skills in managing perinatal loss. Perinatal loss, defined as early fetal loss before 20 weeks of gestation and late fetal loss at or after 20 weeks, is a traumatic experience that significantly impacts parents, especially mothers, on biological, psychological, social, and spiritual levels. Prolonged grief reactions can lead to complicated grief, anxiety, depression, hopelessness, and relationship disturbances. Nursing students are trained to adopt a biopsychosocial approach in patient care and are expected to support grieving individuals by normalizing emotions, identifying coping strategies, and facilitating healthy grief processing. Simulation is recognized as an effective teaching method in developing communication and therapeutic skills among nursing students. This research investigates how simulation-based training can enhance students' therapeutic communication competencies when supporting individuals experiencing perinatal loss.
- Conditions
- Simulation-based Learning, Communication Skills, Paper-Pencil Simulation, High-fidelity Simulation
- Being tested
- High-Fidelity Simulation-Based Therapeutic Communication Training, Paper-Pencil Simulation-Based Therapeutic Communication Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Fidelity Simulation-Based Therapeutic Communication TrainingBehavioural
This intervention involves a structured, high-fidelity simulation scenario in a clinical skills lab setting using mannequins and standardized patients. The scenario focuses on communication with a patient experiencing perinatal loss. The session includes pre-briefing, simulation, and debriefing components.
Paper-Pencil Simulation-Based Therapeutic Communication TrainingBehavioural
This intervention utilizes a written clinical case scenario related to perinatal loss. Students read the scenario and write appropriate therapeutic communication responses, followed by group discussion and instructor feedback. The focus is on reflection and theoretical integration.
| Study group | Role | What they receive |
|---|---|---|
| High-Fidelity Simulation-Based Therapeutic Communication Training | Experimental | Participants in this group engaged in a high-fidelity simulation scenario involving perinatal loss, using a realistic clinical setting with mannequins and role-play. The simulation aimed to provide an experiential learning environment that fosters emotional engagement and realistic practice of therapeutic communication techniques. Students received a structured debriefing session following the simulation. Receives: Behavioral: High-Fidelity Simulation-Based Therapeutic Communication Training |
| Paper-Pencil Simulation-Based Therapeutic Communication Training | Active comparator | Participants in this group participated in a paper-pencil simulation that presented a written clinical scenario involving perinatal loss. Students were asked to analyze the situation, write down appropriate therapeutic communication responses, and discuss these in a guided session. This method focused on the cognitive application of theoretical knowledge in a reflective and structured manner. Receives: Behavioral: Paper-Pencil Simulation-Based Therapeutic Communication Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic Communication Skills Performance
Students' ability to effectively demonstrate therapeutic communication skills during a simulated patient encounter involving perinatal loss. Assessed using the Therapeutic Communication with Patients Experiencing Perinatal Loss Simulation Application Checklist, which evaluates competencies such as providing presence, empathy, active listening, calming guidance, providing psychological support, and applying therapeutic communication techniques. Performance is rated as "Yes," "Partially," or "No" based on observed behaviors.
Measured: Immediately during scenario completion (Day 1)
Perceived Communication Skills Self-Assessment
Students' self-evaluation of their communication abilities following the simulation experience, measured by the Communication Skills Assessment Form. This form covers 20 communication techniques, both therapeutic and nontherapeutic, rated on a 10-point scale, with higher scores reflecting stronger perceived communication competencies.
Measured: Immediately before debriefing session (Day 1)
Student Satisfaction and Self-Confidence in Learning Scale (SCLS)
Students' level of satisfaction with the simulation-based learning experience and their self-confidence in applying learned skills, assessed through the Student Satisfaction and Self-Confidence in Learning Scale (SCLS). The scale includes two subdimensions-Student Satisfaction and Self-Confidence in Learning-measured via a 5-point Likert scale. Higher scores indicate greater satisfaction with the simulation and higher confidence in using therapeutic communication skills.
Measured: Immediately after debriefing session (Day 1)
Simulation Execution Checklist Evaluation
The degree to which the simulation was implemented according to planned steps and standards. This outcome measures the fidelity, completeness, and quality of the simulation process itself, as evaluated by observers using a checklist. It ensures consistency, scenario realism, and adherence to key components critical for achieving the intended learning objectives.
Measured: During scenario execution (Day 1)
Secondary outcomes (1)
Reflection on Learning and Communication Effectiveness
Students' ability to critically reflect on their learning experiences and assess the effectiveness of their communication during the simulation. Reflection focuses on recognizing strengths and areas for improvement in therapeutic communication, understanding emotional responses during patient interactions, and identifying strategies for enhancing future clinical practice. This outcome promotes self-awareness, deeper learning, and the internalization of communication skills through structured debriefing and written or verbal reflections.
Measured: Immediately after debriefing session (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start1 Dec 2024
- Primary completion30 Jan 2025
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Simulation-based LearningStudies 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
- Model description
- Parallel Assignment Randomized Controlled Experimental Design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Coskun, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06959875
- Sponsor's protocol ID
- 2025/05-188
- Status last verified
- Apr 2025
- First submitted
- 16 Apr 2025
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will be stored in an online database (e.g., Mendeley). Data will be available upon request after the study results are published by the researchers.
Publications
Adib-Rad H, Basirat Z, Faramarzi M, Mostafazadeh A, Bijani A. Psychological distress in women with recurrent spontaneous abortion: A case-control study. Turk J Obstet Gynecol. 2019 Sep;16(3):151-157. doi: 10.4274/tjod.galenos.2019.88899. Epub 2019 Oct 10.
PubMed 31673466Graneheim UH, Lundman B. Qualitative content analysis in nursing research: concepts, procedures and measures to achieve trustworthiness. Nurse Educ Today. 2004 Feb;24(2):105-12. doi: 10.1016/j.nedt.2003.10.001.
PubMed 14769454Hanshaw SL, Dickerson SS. High fidelity simulation evaluation studies in nursing education: A review of the literature. Nurse Educ Pract. 2020 Jul;46:102818. doi: 10.1016/j.nepr.2020.102818. Epub 2020 Jun 9.
PubMed 32623148Herbert D, Young K, Pietrusinska M, MacBeth A. The mental health impact of perinatal loss: A systematic review and meta-analysis. J Affect Disord. 2022 Jan 15;297:118-129. doi: 10.1016/j.jad.2021.10.026. Epub 2021 Oct 20.
PubMed 34678403Kang SJ, Kim Y. The Impact of Perinatal Loss Nursing Simulation among Undergraduate Students. Int J Environ Res Public Health. 2022 Jul 14;19(14):8569. doi: 10.3390/ijerph19148569.
PubMed 35886421Kim J, Park JH, Shin S. Effectiveness of simulation-based nursing education depending on fidelity: a meta-analysis. BMC Med Educ. 2016 May 23;16:152. doi: 10.1186/s12909-016-0672-7.
PubMed 27215280Leyland A, Choucri L. Student midwives' lived experiences of caring for bereaved parents following perinatal loss using actor-based simulation: A phenomenological study. Midwifery. 2024 Mar;130:103913. doi: 10.1016/j.midw.2023.103913. Epub 2024 Jan 10.
PubMed 38241799Li YY, Au ML, Tong LK, Ng WI, Wang SC. High-fidelity simulation in undergraduate nursing education: A meta-analysis. Nurse Educ Today. 2022 Apr;111:105291. doi: 10.1016/j.nedt.2022.105291. Epub 2022 Feb 3.
PubMed 35158134Rudland JR, Golding C, Wilkinson TJ. The stress paradox: how stress can be good for learning. Med Educ. 2020 Jan;54(1):40-45. doi: 10.1111/medu.13830. Epub 2019 Sep 11.
PubMed 31509282
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Methods in Therapeutic Communication Training for Student Nurses in the Perinatal Loss: High-Fidelity Simulation and Paper - Pencil Simulation
- ClinicalTrials.gov ID
- NCT06959875
- Acronym / sponsor ID
- 2025/05-188
- Conditions
- Simulation-based Learning, Communication Skills, Paper-Pencil Simulation, High-fidelity Simulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 7 May 2025 (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.
This study aims to evaluate the effect of simulation-based education on nursing students' therapeutic communication skills in managing perinatal loss. Perinatal loss, defined as early fetal loss before 20 weeks of gestation and late fetal loss at or after 20 weeks, is a traumatic experience that significantly impacts parents, especially mothers, on biological, psychological, social, and spiritual levels. Prolonged grief reactions can lead to complicated grief, anxiety, depression, hopelessness, and relationship disturbances. Nursing students are trained to adopt a biopsychosocial approach in patient care and are expected to support grieving individuals by normalizing emotions, identifying coping strategies, and facilitating healthy grief processing. Simulation is recognized as an effective teaching method in developing communication and therapeutic skills among nursing students. This research investigates how simulation-based training can enhance students' therapeutic communication competencies when supporting individuals experiencing perinatal loss.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Parallel Assignment Randomized Controlled Experimental Design
| Arm | Type | Receives |
|---|---|---|
| High-Fidelity Simulation-Based Therapeutic Communication Training | Experimental | Behavioral: High-Fidelity Simulation-Based Therapeutic Communication TrainingParticipants in this group engaged in a high-fidelity simulation scenario involving perinatal loss, using a realistic clinical setting with mannequins and role-play. The simulation aimed to provide an experiential learning environment that fosters emotional engagement and realistic practice of therapeutic communication techniques. Students received a structured debriefing session following the simulation. |
| Paper-Pencil Simulation-Based Therapeutic Communication Training | Active comparator | Behavioral: Paper-Pencil Simulation-Based Therapeutic Communication TrainingParticipants in this group participated in a paper-pencil simulation that presented a written clinical scenario involving perinatal loss. Students were asked to analyze the situation, write down appropriate therapeutic communication responses, and discuss these in a guided session. This method focused on the cognitive application of theoretical knowledge in a reflective and structured manner. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Completion of the theoretical course on postpartum care in the Women's Health and Diseases Nursing course.
- Successful completion of the Human Behavior and Communication course.
- Completion of training on perinatal grief and therapeutic communication skills prior to the simulation training.
Key exclusion criteria (4 listed)
- Medical or Psychological Conditions Impacting Communication
- Incomplete Training or Lack of Pre-Simulation Education
- Inability to Participate in the Debriefing Session
- Language Barriers
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 |
|---|---|---|
| High-Fidelity Simulation-Based Therapeutic Communication TrainingThis intervention involves a structured, high-fidelity simulation scenario in a clinical skills lab setting using mannequins and standardized patients. The scenario focuses on communication with a patient experiencing perinatal loss. The session includes pre-briefing, simulation, and debriefing components. | Behavioural | High-Fidelity Simulation-Based Therapeutic Communication Training |
| Paper-Pencil Simulation-Based Therapeutic Communication TrainingThis intervention utilizes a written clinical case scenario related to perinatal loss. Students read the scenario and write appropriate therapeutic communication responses, followed by group discussion and instructor feedback. The focus is on reflection and theoretical integration. | Behavioural | Paper-Pencil Simulation-Based Therapeutic Communication Training |
Primary outcome
Therapeutic Communication Skills Performance
Time frame: Immediately during scenario completion (Day 1)
Students' ability to effectively demonstrate therapeutic communication skills during a simulated patient encounter involving perinatal loss. Assessed using the Therapeutic Communication with Patients Experiencing Perinatal Loss Simulation Application Checklist, which evaluates competencies such as providing presence, empathy, active listening, calming guidance, providing psychological support, and applying therapeutic communication techniques. Performance is rated as "Yes," "Partially," or "No" based on observed behaviors.
Perceived Communication Skills Self-Assessment
Time frame: Immediately before debriefing session (Day 1)
Students' self-evaluation of their communication abilities following the simulation experience, measured by the Communication Skills Assessment Form. This form covers 20 communication techniques, both therapeutic and nontherapeutic, rated on a 10-point scale, with higher scores reflecting stronger perceived communication competencies.
Student Satisfaction and Self-Confidence in Learning Scale (SCLS)
Time frame: Immediately after debriefing session (Day 1)
Students' level of satisfaction with the simulation-based learning experience and their self-confidence in applying learned skills, assessed through the Student Satisfaction and Self-Confidence in Learning Scale (SCLS). The scale includes two subdimensions-Student Satisfaction and Self-Confidence in Learning-measured via a 5-point Likert scale. Higher scores indicate greater satisfaction with the simulation and higher confidence in using therapeutic communication skills.
Simulation Execution Checklist Evaluation
Time frame: During scenario execution (Day 1)
The degree to which the simulation was implemented according to planned steps and standards. This outcome measures the fidelity, completeness, and quality of the simulation process itself, as evaluated by observers using a checklist. It ensures consistency, scenario realism, and adherence to key components critical for achieving the intended learning objectives.
1 secondary outcome
Reflection on Learning and Communication Effectiveness
Time frame: Immediately after debriefing session (Day 1)
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 7 May 2025.
- Background: PubMed 31673466Adib-Rad H, Basirat Z, Faramarzi M, Mostafazadeh A, Bijani A. Psychological distress in women with recurrent spontaneous abortion: A case-control study. Turk J Obstet Gynecol. 2019 Sep;16(3):151-157. doi: 10.4274/tjod.galenos.2019.88899. Epub 2019 Oct 10.
- Background: PubMed 14769454Graneheim UH, Lundman B. Qualitative content analysis in nursing research: concepts, procedures and measures to achieve trustworthiness. Nurse Educ Today. 2004 Feb;24(2):105-12. doi: 10.1016/j.nedt.2003.10.001.
- Background: PubMed 32623148Hanshaw SL, Dickerson SS. High fidelity simulation evaluation studies in nursing education: A review of the literature. Nurse Educ Pract. 2020 Jul;46:102818. doi: 10.1016/j.nepr.2020.102818. Epub 2020 Jun 9.
- Background: PubMed 34678403Herbert D, Young K, Pietrusinska M, MacBeth A. The mental health impact of perinatal loss: A systematic review and meta-analysis. J Affect Disord. 2022 Jan 15;297:118-129. doi: 10.1016/j.jad.2021.10.026. Epub 2021 Oct 20.
- Background: PubMed 35886421Kang SJ, Kim Y. The Impact of Perinatal Loss Nursing Simulation among Undergraduate Students. Int J Environ Res Public Health. 2022 Jul 14;19(14):8569. doi: 10.3390/ijerph19148569.
- Background: PubMed 27215280Kim J, Park JH, Shin S. Effectiveness of simulation-based nursing education depending on fidelity: a meta-analysis. BMC Med Educ. 2016 May 23;16:152. doi: 10.1186/s12909-016-0672-7.
- Background: PubMed 38241799Leyland A, Choucri L. Student midwives' lived experiences of caring for bereaved parents following perinatal loss using actor-based simulation: A phenomenological study. Midwifery. 2024 Mar;130:103913. doi: 10.1016/j.midw.2023.103913. Epub 2024 Jan 10.
- Background: PubMed 35158134Li YY, Au ML, Tong LK, Ng WI, Wang SC. High-fidelity simulation in undergraduate nursing education: A meta-analysis. Nurse Educ Today. 2022 Apr;111:105291. doi: 10.1016/j.nedt.2022.105291. Epub 2022 Feb 3.
- Background: PubMed 31509282Rudland JR, Golding C, Wilkinson TJ. The stress paradox: how stress can be good for learning. Med Educ. 2020 Jan;54(1):40-45. doi: 10.1111/medu.13830. Epub 2019 Sep 11.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will be stored in an online database (e.g., Mendeley). Data will be available upon request after the study results are published by the researchers.
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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 High-Fidelity Simulation-Based Therapeutic Communication Training and Paper-Pencil Simulation-Based Therapeutic Communication Training in people with Simulation-based Learning and Communication Skills, run by Acibadem 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 3 inclusion and 4 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 7 May 2025. 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?
Therapeutic Communication Skills Performance (time frame: Immediately during scenario completion (Day 1)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06959875, which also lists 9 linked publications.
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 7 May 2025.