NCT07699887

Brief Summary

This randomized controlled trial aims to compare the effects of a web-based compassion-focused writing program and a reflective writing program on psychological well-being, self-compassion, postpartum trauma-related stress symptoms, and post-traumatic growth in midwives working in delivery rooms.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Oct 2026

Shorter than P25 for not_applicable

Status
not yet 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

First Submitted

Initial submission to the registry

July 7, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 13, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2027

Last Updated

July 14, 2026

Status Verified

July 1, 2026

Enrollment Period

1 month

First QC Date

July 7, 2026

Last Update Submit

July 11, 2026

Conditions

Keywords

Compassion-focused writingReflective writingMidwifePsychological well-beingTrauma

Outcome Measures

Primary Outcomes (4)

  • Psychological Well-Being

    Participants' psychological well-being will be assessed using the Psychological Well-Being Scale developed by Diener et al. (2010) to measure socio-psychological well-being. The scale consists of 8 items rated on a 7-point Likert scale ranging from 1 ("Strongly disagree") to 7 ("Strongly agree"). Total scores range from 8 to 56, with higher scores indicating greater psychological well-being and stronger psychological resources. The Turkish version of the scale demonstrated good internal consistency, with a Cronbach's alpha coefficient of 0.80 (Telef, 2013).

    Within 24 hours before the intervention, within 24 hours after the intervention, and 6-8 weeks after the intervention

  • Self-Compassion

    Participants' self-compassion will be assessed using the Self-Compassion Scale developed by Neff (2003). The scale measures individuals' levels of self-kindness, acceptance, and compassion toward themselves. The Turkish version consists of 24 items rated on a 5-point Likert scale. It includes six subscales: self-kindness, self-judgment, common humanity, isolation, mindfulness, and over-identification. Total scores range from 24 to 120, with higher scores indicating greater self-compassion. The Turkish version demonstrated good reliability, with a Cronbach's alpha coefficient of 0.89 and a test-retest reliability coefficient of 0.83 (Deniz, Kesici, \& Sümer, 2008).

    Within 24 hours before the intervention, within 24 hours after the intervention, and 6-8 weeks after the intervention

  • Birth-Related Traumatic Stress Symptoms

    Participants' birth-related traumatic stress symptoms will be assessed using the City Birth Trauma Scale - Maternal Health Professional Version, developed by McInnes et al. (2025). The scale is based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for post-traumatic stress disorder and is designed to assess birth-related traumatic stress symptoms among maternal healthcare professionals providing care during the antenatal, intrapartum, and postpartum periods. Total PTSD symptom scores range from 0 (minimum) to 60 (maximum), with higher scores indicating more severe birth-related post-traumatic stress disorder symptoms.The scale consists of 29 items, with higher total scores indicating more severe birth-related post-traumatic stress disorder symptoms.

    Within 24 hours before the intervention and 6-8 weeks after the intervention

  • Posttraumatic Growth

    Participants' posttraumatic growth will be assessed using the Posttraumatic Growth Inventory-Short Form, developed by Platte et al. (2023). The scale consists of 10 items rated on a 6-point Likert scale, with total scores ranging from 0 to 50. Higher scores indicate greater positive psychological growth following a traumatic or highly stressful experience. The original version demonstrated good internal consistency, with a Cronbach's alpha coefficient of 0.88. The Turkish version also demonstrated good reliability, with a Cronbach's alpha coefficient of 0.81 (Türk et al., 2025).

    Within 24 hours before the intervention and 6-8 weeks after the intervention

Study Arms (2)

Compassion-Focused Writing Program

EXPERIMENTAL

Participants assigned to this group will complete a five-week web-based compassion-focused writing program consisting of structured writing exercises aimed at enhancing self-compassion, increasing empathy, supporting emotional awareness, and strengthening coping skills related to challenging birth experiences. Sessions will be conducted once per week via an online platform.

Behavioral: Compassion-Focused Writing Program

Reflective Writing Program

PLACEBO COMPARATOR

Participants in this group will complete a five-week web-based reflective writing program consisting of structured writing exercises designed to encourage reflection on professional experiences, emotional responses, and thoughts related to delivery room practices. Sessions will be conducted once per week via an online platform.

Behavioral: Reflective Writing Program

Interventions

The web-based compassion-focused writing program consists of five structured writing sessions designed to enhance self-compassion, empathy, emotional awareness, and coping skills related to challenging birth experiences.

Compassion-Focused Writing Program

The web-based reflective writing program consists of structured online writing exercises designed to facilitate reflective thinking, emotional expression, and self-awareness.

Reflective Writing Program

Eligibility Criteria

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

You may qualify if:

  • Working as a midwife in a delivery room between November 1, 2025, and February 15, 2027
  • Native Turkish speaker
  • Female
  • Aged between 18-65 years
  • Having at least a bachelor's degree in midwifery
  • Having at least three years of delivery room experience
  • No diagnosed psychological or psychiatric disorder
  • Having the technical infrastructure to use a web-based program
  • Ability to use a smartphone, tablet, or computer
  • Voluntary agreement to participate in the study

You may not qualify if:

  • Not working in a delivery room during the specified dates
  • Not a native Turkish speaker
  • Under 18 or over 65 years of age
  • Male
  • Changing clinical unit during the study
  • Not completing all five intervention sessions
  • Working less than 40 hours per week in the delivery room due to leave or reassignment
  • Voluntary withdrawal from the study at any stage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Uddin N, Ayers S, Khine R, Webb R. The perceived impact of birth trauma witnessed by maternity health professionals: A systematic review. Midwifery. 2022 Nov;114:103460. doi: 10.1016/j.midw.2022.103460. Epub 2022 Aug 13.

  • Hajiesmaello M, Hajian S, Riazi H, Majd HA, Yavarian R. Secondary traumatic stress in iranian midwives: stimuli factors, outcomes and risk management. BMC Psychiatry. 2022 Jan 24;22(1):56. doi: 10.1186/s12888-022-03707-7.

MeSH Terms

Conditions

Psychological Well-BeingCompassion FatigueOccupational StressWounds and Injuries

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorMental FatigueFatigueSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsStress, PsychologicalOccupational Diseases

Central Study Contacts

Gözde Gökçe İsbir

CONTACT

Zehra Yıldırım

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 7, 2026

First Posted

July 13, 2026

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

February 15, 2027

Last Updated

July 14, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share