- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07699887
The Effect of Web-Based Compassion-Focused Structured Writing Programs on Well-Being in Midwives Working in Delivery Rooms
July 7, 2026 updated by: Gozde Gokce Isbir, Mersin University
The Effect of Web-Based Compassion-Focused Writing Program and Reflective Writing Program on Psychological Outcomes in Midwives Working in Delivery Rooms: A Randomized Controlled Trial
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.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Detailed Description
This study is planned as a single-blind, parallel-group randomized controlled trial to evaluate the effects of two different writing-based interventions on psychological outcomes in midwives working in delivery rooms.
During the childbirth process, midwives may occasionally witness traumatic events, which may lead to secondary traumatic stress, burnout, and various psychological difficulties.
The literature indicates that expressive writing, reflective writing, and compassion-focused writing approaches contribute to individuals' ability to make sense of traumatic experiences, enhance emotional regulation skills, and support psychological well-being.
Accordingly, this study aims to examine the effects of writing-based interventions that may support the psychological resilience of midwives.
A total of 90 midwives who meet the inclusion criteria will be included in the study and randomly assigned to two groups using a computer-generated random number sequence.
One group will receive a web-based compassion-focused writing program, while the other group will receive a web-based reflective writing program.
Both programs will consist of five sessions conducted once per week via an online platform.
Data will be collected using a Personal Information Form, Psychological Well-Being Scale, Self-Compassion Scale, City Birth Trauma Scale, and Post-Traumatic Growth Scale - Short Form.
Measurements will be conducted before the intervention, immediately after the completion of the program, and during the follow-up period.
Additionally, after each session, participants will complete a brief questionnaire to evaluate their writing experience.
The collected data will be analyzed using appropriate statistical methods to compare the effects of both writing programs on psychological well-being, self-compassion, post-traumatic growth, and trauma-related stress symptoms.
Study Type
Interventional
Enrollment (Estimated)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Gözde Gökçe İsbir
- Phone Number: +905057782319
- Email: gozdegokce@gmail.com
Study Contact Backup
- Name: Zehra Yıldırım
- Phone Number: +905464313760
- Email: ebezehrayldrm@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Compassion-Focused Writing Program
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.
|
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.
|
|
Placebo Comparator: Reflective Writing Program
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.
|
The web-based reflective writing program consists of structured online writing exercises designed to facilitate reflective thinking, emotional expression, and self-awareness.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Psychological Well-Being
Time Frame: Within 24 hours before the intervention, within 24 hours after the intervention, and 6-8 weeks after the intervention
|
Participants' psychological well-being will be assessed using the Psychological Well-Being Scale (PWBS) 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
Time Frame: Within 24 hours before the intervention, within 24 hours after the intervention, and 6-8 weeks after the intervention
|
Participants' self-compassion will be assessed using the Self-Compassion Scale (SCS) 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
Time Frame: Within 24 hours before the intervention and 6-8 weeks after the intervention
|
Participants' birth-related traumatic stress symptoms will be assessed using the City Birth Trauma Scale - Maternal Health Professional Version (City BiTS-MHP), developed by McInnes et al. (2025).
The scale is based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for post-traumatic stress disorder (PTSD) and is designed to assess birth-related traumatic stress symptoms among maternal healthcare professionals providing care during the antenatal, intrapartum, and postpartum periods.
The scale consists of 29 items, with higher total scores indicating more severe birth-related PTSD symptoms.
|
Within 24 hours before the intervention and 6-8 weeks after the intervention
|
|
Posttraumatic Growth Inventory-Short Form (PTGI-SF)
Time Frame: Within 24 hours before the intervention and 6-8 weeks after the intervention
|
Participants' posttraumatic growth will be assessed using the Posttraumatic Growth Inventory-Short Form (PTGI-SF), 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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
October 1, 2026
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
February 15, 2027
Study Registration Dates
First Submitted
July 7, 2026
First Submitted That Met QC Criteria
July 7, 2026
First Posted (Actual)
July 13, 2026
Study Record Updates
Last Update Posted (Actual)
July 13, 2026
Last Update Submitted That Met QC Criteria
July 7, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZYildirim
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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