Psychological Well-beingNCT07699887
The Effect of Web-Based Compassion-Focused Structured Writing Programs on Well-Being in Midwives Working in Delivery Rooms
A study testing Compassion-Focused Writing Program and Reflective Writing Program in people with Psychological Well-being and Secondary Traumatic Stress, run by Mersin University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Psychological Well-being, Secondary Traumatic Stress, Occupational Stress
- What is being tested?
- Compassion-Focused Writing Program and Reflective Writing Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 15 Feb 2027
- 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 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Being tested
- Compassion-Focused Writing Program, Reflective Writing Program
- Keywords
- Compassion-focused writing, Reflective writing, Midwife, Psychological well-being, Trauma
- Medical subject headings
- Psychological Well-Being, Compassion Fatigue, Occupational Stress, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compassion-Focused Writing ProgramBehavioural
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.
Reflective Writing ProgramBehavioural
The web-based reflective writing program consists of structured online writing exercises designed to facilitate reflective thinking, emotional expression, and self-awareness.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Reflective Writing Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: Within 24 hours before the intervention and 6-8 weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Psychological Well-beingStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
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
- NCT07699887
- Sponsor's protocol ID
- ZYildirim
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 36058189Hajiesmaello 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.
PubMed 35073852
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07699887
- Acronym / sponsor ID
- ZYildirim
- Keywords
- Compassion-focused writing, Reflective writing, Midwife, Psychological well-being, Trauma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 15 Feb 2027 (estimated)
- First posted
- 13 Jul 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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Compassion-Focused Writing Program | Experimental | Behavioral: Compassion-Focused Writing ProgramParticipants 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. |
| Reflective Writing Program | Placebo comparator | Behavioral: Reflective Writing ProgramParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Compassion-Focused Writing ProgramThe 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. | Behavioural | Compassion-Focused Writing Program |
| Reflective Writing ProgramThe web-based reflective writing program consists of structured online writing exercises designed to facilitate reflective thinking, emotional expression, and self-awareness. | Behavioural | Reflective Writing Program |
Primary outcome
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 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).
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 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).
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, 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.
Posttraumatic Growth
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, 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).
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 14 Jul 2026.
- Results publication: PubMed 36058189Uddin 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.
- Results publication: PubMed 35073852Hajiesmaello 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.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Compassion-Focused Writing Program and Reflective Writing Program in people with Psychological Well-being and Secondary Traumatic Stress, run by Mersin University.
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 10 inclusion and 8 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: opening soon, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Contact Gözde Gökçe İsbir (+905057782319, gozdegokce@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological Well-Being (time frame: Within 24 hours before the intervention, within 24 hours after the intervention, and 6-8 weeks after the intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07699887, which also lists 2 linked publications.
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 14 Jul 2026.