Clinical Self-EfficacyNCT07322484
Supportive Care-Based Training and Psychological Outcomes in Midwifery Students
A study testing Universal Continuous Supportive Care Model Training and Trauma-Informed Supportive Care Model Training in people with Clinical Self-Efficacy and Psychological Outcomes, run by Mersin University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Clinical Self-Efficacy, Psychological Outcomes, Secondary Traumatic Stress
- What is being tested?
- Universal Continuous Supportive Care Model Training and Trauma-Informed Supportive Care Model Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2025to 8 Jul 2026
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Withdrawal from the study at any stage upon the participant's own request
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Training Programs Based on Different Supportive Care Models in Childbirth on Midwifery Students' Clinical Self-Efficacy and Psychological Outcomes
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.
Read the detailed description
This study was designed as a quasi-experimental comparative study. Data will be collected from fourth-year midwifery students enrolled in the Midwifery Department of Mersin University during the 2025-2026 academic year who undertake clinical practice in the delivery room of Mersin City Training and Research Hospital. Students who meet the inclusion criteria will be informed about the purpose and procedures of the study, and written informed consent will be obtained. Participants will be allocated to either the universal supportive care model training group or the trauma-informed supportive care model training group based on their academic semester (fall or spring), in line with the existing curriculum structure.
Both training programs will be delivered through theoretical and practical sessions prior to clinical application. Data will be collected from the participants themselves at three time points: before the intervention, immediately after providing childbirth care in the delivery room, and one week after the intervention, using validated self-report measurement tools assessing clinical skill self-efficacy, state and trait anxiety, and secondary traumatic stress levels. The planning, implementation, and reporting of the study will be conducted in accordance with relevant ethical principles and reporting guidelines for quasi-experimental research.
- Being tested
- Universal Continuous Supportive Care Model Training, Trauma-Informed Supportive Care Model Training
- Keywords
- Trauma-Informed Care, Supportive Care Models in Childbirth, Midwifery Education, Clinical Self-Efficacy, Anxiety, Secondary traumatic stress
- Medical subject headings
- Compassion Fatigue, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Universal Continuous Supportive Care Model TrainingOther
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.
Trauma-Informed Supportive Care Model TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Trauma-Informed Supportive Care Model Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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
Midwifery students' secondary traumatic stress levels were assessed using the Secondary Traumatic Stress Scale (STSS), developed by Bride et al. (2005). The scale consists of 17 items across three subdimensions-avoidance, arousal, and intrusion-and is rated on a 5-point Likert scale. Total scores range from 17 to 85, with higher scores indicating higher levels of secondary traumatic stress. The Turkish version of the scale demonstrated high internal consistency, with a reported Cronbach's alpha coefficient of .91.
Measured: Time Frame: one week after completion of delivery room clinical practice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start15 Sep 2025
- Primary completion8 Jul 2026 (estimated)
- Study completion8 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Self-EfficacyStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gozde Gokce Isbir, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07322484
- Sponsor's protocol ID
- AGY
- Status last verified
- Sep 2025
- First submitted
- 22 Dec 2025
- Last updated
- 7 Jan 2026
- 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 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Training Programs Based on Different Supportive Care Models in Childbirth on Midwifery Students' Clinical Self-Efficacy and Psychological Outcomes
- ClinicalTrials.gov ID
- NCT07322484
- Acronym / sponsor ID
- AGY
- Keywords
- Trauma-Informed Care, Supportive Care Models in Childbirth, Midwifery Education, Clinical Self-Efficacy, Anxiety, Secondary traumatic stress
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 8 Jul 2026 (estimated)
- Study completion
- 8 Jul 2026 (estimated)
- First posted
- 7 Jan 2026 (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 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.
Detailed description
This study was designed as a quasi-experimental comparative study. Data will be collected from fourth-year midwifery students enrolled in the Midwifery Department of Mersin University during the 2025-2026 academic year who undertake clinical practice in the delivery room of Mersin City Training and Research Hospital. Students who meet the inclusion criteria will be informed about the purpose and procedures of the study, and written informed consent will be obtained. Participants will be allocated to either the universal supportive care model training group or the trauma-informed supportive care model training group based on their academic semester (fall or spring), in line with the existing curriculum structure.
Both training programs will be delivered through theoretical and practical sessions prior to clinical application. Data will be collected from the participants themselves at three time points: before the intervention, immediately after providing childbirth care in the delivery room, and one week after the intervention, using validated self-report measurement tools assessing clinical skill self-efficacy, state and trait anxiety, and secondary traumatic stress levels. The planning, implementation, and reporting of the study will be conducted in accordance with relevant ethical principles and reporting guidelines for quasi-experimental research.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Universal Continuous Supportive Care Model Training | Experimental | Other: Universal Continuous Supportive Care Model TrainingThe 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. |
| Trauma-Informed Supportive Care Model Training | Experimental | Other: Trauma-Informed Supportive Care Model TrainingThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Withdrawal from the study at any stage upon the participant's own request
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 |
|---|---|---|
| Universal Continuous Supportive Care Model TrainingThe 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 TrainingThe 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 |
Primary outcome
Clinical Skills Self-Efficacy
Time frame: before the training and immediately after completion of delivery room clinical practice
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).
State and Trait Anxiety
Time frame: Trait Anxiety-before the training and one week after completion of delivery room practice; State Anxiety-immediately after completion of delivery room practice
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.
1 secondary outcome
Secondary Traumatic Stress
Time frame: Time Frame: one week after completion of delivery room clinical practice
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 7 Jan 2026.
- 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. 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 Universal Continuous Supportive Care Model Training and Trauma-Informed Supportive Care Model Training in people with Clinical Self-Efficacy and Psychological Outcomes, run by Mersin 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 6 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 7 Jan 2026. 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?
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?
Clinical Skills Self-Efficacy (time frame: before the training and immediately after completion of delivery room clinical practice). The study lists 2 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 7 Jan 2026.