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Not yet recruitingNCT07889986PEEBMEMSPWUpdated Oct 22, 2026

Psychosocial Effects of Empathy-Based Midwifery Education on Midwifery Students and Pregnant Women

An interventional study of Empathy-Based Midwifery Education and Empathy-Based Midwifery Support During Labor in Empathy, Anxiety and Childbirth, sponsored by Kahramanmaras Sutcu Imam University. Not yet recruiting. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-22.

Sponsored by Kahramanmaras Sutcu Imam University · Not applicable, Interventional, and Health services research

Updated Oct 22, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
224
Allocation
Non-randomized
Ages
18 Years and older
Sex
Female
01

Study summary

This two-stage quasi-experimental study will evaluate the effects of empathy-based midwifery education on midwifery students' empathy and anxiety, and on women's satisfaction with childbirth and perceptions of traumatic birth.

In the first stage, third-year midwifery students in the intervention group will receive four face-to-face training sessions over two weeks, totaling 390 minutes. The program will include theoretical instruction, case discussions, role-play, virtual reality activities, mannequin-based simulation, and guided reflection. Students in the control group will continue their usual coursework and clinical practice. Students' empathy and anxiety will be assessed before and after the training.

In the second stage, trained students will provide empathetic communication and psychosocial support to women during labor under the supervision of a faculty member and/or the responsible midwife. Support will include active listening, clear information, reassurance, respect for privacy, and assistance with coping during labor. Women in the control group will receive routine maternity care. Maternal satisfaction with childbirth and perceptions of traumatic birth will be assessed after birth, once the mother and newborn are clinically stable.

The study will examine whether this educational program improves students' empathy, reduces their anxiety, and contributes to more positive childbirth experiences for women.

Read the detailed description

This two-stage quasi-experimental study will evaluate the effects of empathy-based midwifery education on midwifery students' empathic tendencies and state anxiety, and the effects of care provided by trained students on women's satisfaction with childbirth and perceptions of traumatic birth. The study links a structured educational intervention with its subsequent application in the clinical setting.

In the first stage, third-year midwifery students enrolled in the Normal Birth and Postpartum Period course and participating in delivery room clinical placements will be invited to participate. The minimum required student sample is 82. All 84 students enrolled in the eligible class will be invited, and consenting students will be assigned to intervention and control groups in approximately equal numbers. If all eligible students participate, each group will include 42 students. Both groups will receive the same routine course curriculum and clinical education.

Students in the intervention group will additionally receive a face-to-face, group-based empathy education program delivered over two weeks, with two sessions per week. The program comprises four sessions totaling 390 minutes and will take place outside routine course and clinical placement hours. The first session will address empathy, empathic tendencies, woman-centered midwifery care, and respectful maternity care through theoretical instruction, questions and answers, and group discussion (90 minutes). The second session will focus on empathic communication during labor, including recognition of women's fear, anxiety, pain, uncertainty, and support needs, using case discussions and role-play (90 minutes). The third session will involve a virtual reality delivery room experience and structured scenarios using a simulation mannequin to practice empathic communication, reassurance, information provision, privacy protection, and supportive care (120 minutes). The fourth session will include debriefing, feedback, and group reflection to support preparation for clinical practice (90 minutes). Control group students will continue routine education and clinical placements without receiving the additional structured program during the study period.

Student demographic characteristics and previous educational and clinical experiences will be recorded using a Student Information Form. Empathic tendencies and state anxiety will be assessed before and after the educational intervention using the Empathic Tendency Scale and the State Anxiety Inventory, respectively. Changes within groups and differences between groups will be evaluated.

In the second stage, 140 women admitted to the delivery room during labor will be enrolled in intervention and control groups. Eligible women will be aged 18 years or older, at 37-42 weeks of gestation, have a singleton live pregnancy, plan a vaginal birth, be able to communicate in Turkish, and provide informed consent. Sociodemographic characteristics and obstetric history will be recorded at admission using a Pregnant Woman Information and Obstetric History Form.

Women in the intervention group will receive empathy-based communication and psychosocial support from students who have completed the educational program, under the supervision of a faculty member and/or the responsible midwife. The approach will include active listening, recognition of emotional and individual needs, respectful and nonjudgmental communication, clear explanations, reassurance, protection of privacy, support for coping with labor, and appropriate responses to questions. This support will be provided alongside routine clinical care. Clinical decisions and management will remain the responsibility of the healthcare professionals in the delivery room.

Intervention fidelity will be evaluated using a researcher-developed Empathy-Based Midwifery Approach Implementation Checklist finalized following expert review. A supervising faculty member and/or responsible midwife will complete the checklist during clinical practice. Each behavior will be recorded as performed, not performed, or not required.

Women in the control group will receive routine delivery room care, including admission assessment, maternal and fetal monitoring, monitoring of labor progress, indicated clinical care, and postpartum maternal and newborn observation. They will not receive the additional structured psychosocial support intervention from students trained in the study program.

After birth, once the mother and newborn are clinically stable, maternal satisfaction will be assessed using the Scale for Measuring Maternal Satisfaction in Normal Birth, and perceptions of traumatic birth will be assessed using the Traumatic Birth Perception Scale. Higher maternal satisfaction scores indicate greater satisfaction with care, whereas higher traumatic birth perception scores indicate a more negative perception of the birth experience. Women who develop an indication for emergency cesarean delivery, fetal distress, or serious maternal or neonatal complications, or who cannot complete the postpartum assessments, will be excluded according to the study protocol.

Data will be analyzed using descriptive statistics and appropriate parametric or nonparametric tests. Student outcomes will be compared within groups over time and between intervention and control groups. Maternal outcomes will be compared between groups. Analysis of covariance will be used when appropriate to account for baseline student scores.

Participation will be voluntary, and informed consent will be obtained from students and women before data collection. Students' decisions regarding participation will not affect their grades, course assessments, or academic rights. The study will assess whether structured empathy education improves student outcomes and whether its supervised clinical application improves women's childbirth experiences.

02

Conditions studied

  • Empathy
  • Anxiety
  • Childbirth

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Keywords

  • Empathy-Based Education
  • Midwifery Students
  • Simulation-Based Education
  • Woman-Centered Care
03

In context

Anxiety Disorders

5,063 studies on the registry are indexed under Anxiety Disorders; 1,408 are open to participants now.

This study's planned enrollment of 224 is above the median of 80 across 4,339 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Kahramanmaras Sutcu Imam University is the lead sponsor of 195 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:Inclusion Criteria:

Midwifery students:

  • Enrolled in the third year of the undergraduate midwifery program.
  • Enrolled in the Normal Birth and Postpartum Period course.
  • Actively participating in clinical placements.
  • Participating in, or scheduled to participate in, delivery room clinical practice.
  • No previous comprehensive, structured empathy training.
  • Willing to participate and provide informed consent.

Women in labor:

  • Aged 18 years or older.
  • Gestational age between 37 and 42 weeks.
  • Singleton pregnancy with a live fetus.
  • Planned vaginal birth.
  • Able to communicate in Turkish.
  • Willing to participate and provide informed consent.

Exclusion Criteria:

Midwifery students:

  • Failure to attend all four educational sessions and complete any required make-up training, applicable to the intervention group.
  • Failure to complete post-intervention assessments.

Women in labor:

  • Development of an indication for emergency cesarean delivery.
  • Development of fetal distress.
  • Development of serious maternal or neonatal complications.
  • Postpartum clinical condition that prevents completion of the assessment instruments.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
224 participants (estimated)

Study arms

  • No intervention
    Midwifery Students: Routine Education

    Third-year midwifery students will continue the routine Normal Birth and Postpartum Period course and clinical placements. They will receive the same routine curriculum, teaching materials, and educational conditions as intervention group students, without the additional structured empathy-based education program. Empathic tendencies and state anxiety will be assessed at the same assessment points as in the intervention group.

  • Experimental
    Women in Labor: Empathy-Based Midwifery Support

    Women in labor will receive empathy-based communication and psychosocial support from midwifery students who have completed the educational program, under the supervision of a faculty member and/or responsible midwife. Support will include active listening, recognition of emotional needs, respectful communication, clear information, reassurance, privacy protection, and support for coping with labor. The intervention will supplement routine clinical care. Maternal satisfaction and traumatic birth perception will be assessed after birth, once the mother and newborn are clinically stable.

    Behavioral: Empathy-Based Midwifery Support During Labor

  • No intervention
    Women in Labor: Routine Delivery Room Care

    Women in labor will receive routine delivery room care, including admission assessment, maternal and fetal monitoring, monitoring of labor progress, indicated clinical care, and postpartum maternal and newborn observation. They will not receive the additional structured empathy-based psychosocial support intervention from students trained in the study program. Maternal satisfaction and traumatic birth perception will be assessed after birth, once the mother and newborn are clinically stable.

  • Experimental
    Midwifery Students: Empathy-Based Education

    Third-year midwifery students will receive a structured empathy-based education program comprising four sessions over two weeks, totaling 390 minutes, in addition to routine coursework and clinical placements.

    Behavioral: Empathy-Based Midwifery Education

Interventions

  • BehavioralEmpathy-Based Midwifery Education

    A structured, face-to-face educational program delivered in four sessions over two weeks, totaling 390 minutes. The program includes theoretical instruction on empathy and woman-centered care, case discussions and role-play on empathic communication during labor, virtual reality and mannequin-based simulation scenarios, and debriefing with feedback. The program is provided in addition to routine midwifery education and clinical placements.

  • BehavioralEmpathy-Based Midwifery Support During Labor

    Empathy-based communication and psychosocial support provided during labor by midwifery students who have completed the educational program, under the supervision of a faculty member and/or responsible midwife. Support includes active listening, recognition of emotional needs, respectful and nonjudgmental communication, clear information, reassurance, privacy protection, and support for coping with labor. This intervention supplements routine clinical care.

06

What researchers measure

Primary outcomes

  1. Change in Midwifery Students' Empathic Tendency Scores

    Empathic tendencies will be assessed using the Empathic Tendency Scale, a 20-item instrument scored on a five-point Likert scale. Total scores range from 20 to 100, with higher scores indicating greater empathic tendency. Changes from baseline to the post-intervention assessment will be compared between students receiving empathy-based midwifery education and students receiving routine education.

    Time frame: Baseline (before the first training session) and immediately after the final training session, at the end of week 2.

Secondary outcomes

  1. Change in Midwifery Students' State Anxiety Scores

    State anxiety will be assessed using the 20-item state anxiety subscale of the State-Trait Anxiety Inventory. Items are rated on a four-point scale, and total scores range from 20 to 80. Higher scores indicate greater state anxiety. Changes from baseline to the post-intervention assessment will be compared between students receiving empathy-based midwifery education and students receiving routine education.

    Time frame: Baseline (before the first training session) and immediately after the final training session, at the end of week 2.

  2. Maternal Satisfaction with Childbirth

    Maternal satisfaction will be assessed using the Scale for Measuring Maternal Satisfaction in Normal Birth. The instrument consists of 43 items across 10 subscales, rated on a five-point Likert scale. Total scores range from 43 to 215, with higher scores indicating greater satisfaction. Scores will be compared between women receiving empathy-based midwifery support alongside routine care and women receiving routine delivery room care.

    Time frame: Within the first 24 hours after delivery.

  3. Traumatic Birth Perception

    Traumatic birth perception will be assessed using the Traumatic Birth Perception Scale. The instrument consists of 13 items, each scored from 0 to 10. Total scores range from 0 to 130, with higher scores indicating greater perceived birth trauma. Scores will be compared between women receiving empathy-based midwifery support alongside routine care and women receiving routine delivery room care.

    Time frame: Within the first 24 hours after delivery.

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 22, 2026
Show all 1 update
  1. Oct 22, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07889986
Responsible party
Hatice Gul OZTAS (Associate Professor, Head of the Department of Midwifery, Kahramanmaras Sutcu Imam University) — Principal investigator
First posted
Oct 22, 2026
Start date
Oct 25, 2026 (estimated)
Primary completion
Oct 28, 2026 (estimated)
Completion
Jan 30, 2027 (estimated)
Last update
Oct 22, 2026

Study contacts

HATİCE GÜL ÖZTAŞ, DİRECTOR
Contact
haticeguloztas@ksu.edu.tr
0542826762
GÜLDANE DAMLA KAYA
Contact
damlazeytunoglu@gmail.com

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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