Therapeutic Communication Training in Perinatal Loss: Simulation-Based Approaches

NCT ID: NCT06959875

Last Updated: 2025-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2025-01-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Simulation-based Learning Communication Skills Paper-Pencil Simulation High-fidelity Simulation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment Randomized Controlled Experimental Design
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

High-Fidelity Simulation-Based Therapeutic Communication Training

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.

Group Type EXPERIMENTAL

High-Fidelity Simulation-Based Therapeutic Communication Training

Intervention Type BEHAVIORAL

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 Training

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.

Group Type ACTIVE_COMPARATOR

Paper-Pencil Simulation-Based Therapeutic Communication Training

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

High-Fidelity Simulation-Based Therapeutic Communication Training

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.

Intervention Type BEHAVIORAL

Paper-Pencil 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

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

18 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Acibadem University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Merve Coskun

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Merve Coşkun

Ataşehir, Istanbul, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 31673466 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14769454 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32623148 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34678403 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35886421 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27215280 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38241799 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35158134 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31509282 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2025/05-188

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.