NCT06959875

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 7, 2025

Completed
Last Updated

May 7, 2025

Status Verified

April 1, 2025

Enrollment Period

2 months

First QC Date

April 16, 2025

Last Update Submit

April 28, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    During scenario execution (Day 1)

Secondary Outcomes (1)

  • Reflection on Learning and Communication Effectiveness

    Immediately after debriefing session (Day 1)

Study Arms (2)

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.

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.

Behavioral: Paper-Pencil Simulation-Based Therapeutic Communication Training

Interventions

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.

High-Fidelity Simulation-Based Therapeutic Communication Training

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.

Paper-Pencil Simulation-Based Therapeutic Communication Training

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Medical or Psychological Conditions Impacting Communication
  • Incomplete Training or Lack of Pre-Simulation Education
  • Inability to Participate in the Debriefing Session
  • Language Barriers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Merve Coşkun

Ataşehir, Istanbul, Turkey (Türkiye)

Location

Related Publications (9)

  • 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.

    PMID: 31673466BACKGROUND
  • Graneheim 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.

    PMID: 14769454BACKGROUND
  • Hanshaw 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.

    PMID: 32623148BACKGROUND
  • Herbert 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.

    PMID: 34678403BACKGROUND
  • Kang 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.

    PMID: 35886421BACKGROUND
  • Kim 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.

    PMID: 27215280BACKGROUND
  • Leyland 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.

    PMID: 38241799BACKGROUND
  • Li 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.

    PMID: 35158134BACKGROUND
  • Rudland 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.

    PMID: 31509282BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
In the single-blind method, subjects do not know which of the experimental or control groups they were selected and therefore which method was applied to them. The researcher knows the subjects selected for the experimental and control groups, and therefore which method was applied to which subjects.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Parallel Assignment Randomized Controlled Experimental Design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

April 16, 2025

First Posted

May 7, 2025

Study Start

December 1, 2024

Primary Completion

January 30, 2025

Study Completion

January 30, 2025

Last Updated

May 7, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

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.

Locations