NCT07322484

Brief Summary

The aim of this study is to comparatively evaluate the effects of trauma-informed supportive care model training in childbirth and universal supportive care model training in childbirth provided to midwifery students on their clinical skill self-efficacy in the delivery room, state anxiety, and secondary traumatic stress levels.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress80%
Sep 2025Jul 2026

Study Start

First participant enrolled

September 15, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 7, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2026

Last Updated

January 7, 2026

Status Verified

September 1, 2025

Enrollment Period

10 months

First QC Date

December 22, 2025

Last Update Submit

December 22, 2025

Conditions

Keywords

Trauma-Informed CareSupportive Care Models in ChildbirthMidwifery EducationClinical Self-EfficacyAnxietySecondary traumatic stress

Outcome Measures

Primary Outcomes (2)

  • Clinical Skills Self-Efficacy

    Midwifery students' clinical skills self-efficacy was assessed using the Clinical Skills Self-Efficacy Scale (CSSES). The scale was developed by Kang et al. (2019) to evaluate individuals' self-efficacy related to clinical practice. It consists of cognitive, affective, and psychomotor subdimensions. The Turkish version includes 11 items rated on a 5-point Likert scale ranging from 1 = strongly disagree to 5 = strongly agree, with higher scores indicating higher clinical self-efficacy. The Turkish adaptation demonstrated high internal consistency (Cronbach's alpha = .91).

    before the training and immediately after completion of delivery room clinical practice

  • State and Trait Anxiety

    Midwifery students' anxiety levels were assessed using the State-Trait Anxiety Inventory (STAI), developed by Spielberger et al. (1970). The inventory consists of two subscales-State Anxiety and Trait Anxiety-each comprising 20 items rated on a 4-point Likert scale. Some positively worded items are reverse scored. Total scores reflect individuals' current (state) or general (trait) anxiety levels, with higher scores indicating higher anxiety. The Turkish version of the scale demonstrated high reliability, with Cronbach's alpha coefficients ranging from .94-.96 for the State Anxiety subscale and .83-.87 for the Trait Anxiety subscale.

    Trait Anxiety-before the training and one week after completion of delivery room practice; State Anxiety-immediately after completion of delivery room practice

Secondary Outcomes (1)

  • Secondary Traumatic Stress

    Time Frame: one week after completion of delivery room clinical practice

Study Arms (2)

Universal Continuous Supportive Care Model Training

EXPERIMENTAL

The first study group consisted of midwifery students enrolled in the Perinatal Health Practices I course during the fall semester. Following standard hospital orientation, students received Universal Continuous Supportive Care Model Training in childbirth, developed in line with the recommendations of Adams et al. The training lasted four hours, including one hour of theoretical instruction and three hours of practical application. The training focused on the core principles of universal continuous supportive care, their integration into clinical practice, and the use of a supportive care skills checklist. The 20-item checklist was developed by the researchers based on the literature to support students' self-evaluation of supportive care skills and included four domains: physical support, emotional support, education/information, and advocacy. Students were also encouraged to use a structured anamnesis form to plan individualized care.

Other: Universal Continuous Supportive Care Model Training

Trauma-Informed Supportive Care Model Training

EXPERIMENTAL

The second study group consisted of midwifery students enrolled in the Perinatal Health Practices II course during the spring semester. Following standard hospital orientation, students received Trauma-Informed Supportive Care Model Training in childbirth, based on the recommendations of the Centre for Early Child Development. The training lasted four hours, including one hour of theoretical instruction and three hours of practical application. The training addressed the core principles of trauma-informed care, trauma-sensitive communication, and individualized care, with emphasis on integration into clinical practice. A 20-item trauma-informed supportive care checklist was introduced to support students' self-evaluation, structured around recognition and compassion, communication and collaboration, consistency and continuity, and understanding diversity. A trauma-informed anamnesis form was also used to guide individualized care planning.

Other: Trauma-Informed Supportive Care Model Training

Interventions

The second study group consisted of midwifery students enrolled in the Perinatal Health Practices II course during the spring semester. Following standard hospital orientation, students received Trauma-Informed Supportive Care Model Training in childbirth, based on the recommendations of the Centre for Early Child Development. The training lasted four hours, including one hour of theoretical instruction and three hours of practical application. The training addressed the core principles of trauma-informed care, trauma-sensitive communication, and individualized care, with emphasis on integration into clinical practice. A 20-item trauma-informed supportive care checklist was introduced to support students' self-evaluation, structured around recognition and compassion, communication and collaboration, consistency and continuity, and understanding diversity. A trauma-informed anamnesis form was also used to guide individualized care planning.

Trauma-Informed Supportive Care Model Training

The first study group consisted of midwifery students enrolled in the Perinatal Health Practices I course during the fall semester. Following standard hospital orientation, students received Universal Continuous Supportive Care Model Training in childbirth, developed in line with the recommendations of Adams et al. The training lasted four hours, including one hour of theoretical instruction and three hours of practical application. The training focused on the core principles of universal continuous supportive care, their integration into clinical practice, and the use of a supportive care skills checklist. The 20-item checklist was developed by the researchers based on the literature to support students' self-evaluation of supportive care skills and included four domains: physical support, emotional support, education/information, and advocacy. Students were also encouraged to use a structured anamnesis form to plan individualized care.

Universal Continuous Supportive Care Model Training

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Voluntary participation in the study
  • Native Turkish speakers
  • Enrollment as a fourth-year student in the Midwifery Department of Mersin University during the 2025-2026 academic year
  • Enrollment in Perinatal Health Practices I or Perinatal Health Practices II
  • Participation in delivery room clinical practice at Mersin City Training and Research Hospital
  • No diagnosed psychiatric disorder and no use of psychiatric medication

You may not qualify if:

  • Withdrawal from the study at any stage upon the participant's own request

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gozde Gokce Isbir

Mersin, Mersin, 33180, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Compassion FatigueAnxiety Disorders

Condition Hierarchy (Ancestors)

Mental FatigueFatigueSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorOccupational StressStress, PsychologicalMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 22, 2025

First Posted

January 7, 2026

Study Start

September 15, 2025

Primary Completion (Estimated)

July 8, 2026

Study Completion (Estimated)

July 8, 2026

Last Updated

January 7, 2026

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations