- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07699887
The Effect of Web-Based Compassion-Focused Structured Writing Programs on Well-Being in Midwives Working in Delivery Rooms
11 lipca 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Jeszcze nie rekrutacja
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Szacowany)
90
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Gözde Gökçe İsbir
- Numer telefonu: +905057782319
- E-mail: gozdegokce@gmail.com
Kopia zapasowa kontaktu do badania
- Nazwa: Zehra Yıldırım
- Numer telefonu: +905464313760
- E-mail: ebezehrayldrm@gmail.com
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Tak
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Inny
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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.
|
|
Komparator placebo: 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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Psychological Well-Being
Ramy czasowe: 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).
|
Within 24 hours before the intervention, within 24 hours after the intervention, and 6-8 weeks after the intervention
|
|
Self-Compassion
Ramy czasowe: 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).
|
Within 24 hours before the intervention, within 24 hours after the intervention, and 6-8 weeks after the intervention
|
|
Birth-Related Traumatic Stress Symptoms
Ramy czasowe: 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.
|
Within 24 hours before the intervention and 6-8 weeks after the intervention
|
|
Posttraumatic Growth
Ramy czasowe: 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).
|
Within 24 hours before the intervention and 6-8 weeks after the intervention
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- 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.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
1 października 2026
Zakończenie podstawowe (Szacowany)
1 listopada 2026
Ukończenie studiów (Szacowany)
15 lutego 2027
Daty rejestracji na studia
Pierwszy przesłany
7 lipca 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
7 lipca 2026
Pierwszy wysłany (Rzeczywisty)
13 lipca 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
14 lipca 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
11 lipca 2026
Ostatnia weryfikacja
1 lipca 2026
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- ZYildirim
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
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