- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07699887
The Effect of Web-Based Compassion-Focused Structured Writing Programs on Well-Being in Midwives Working in Delivery Rooms
11. Juli 2026 aktualisiert von: 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.
Studienübersicht
Status
Noch keine Rekrutierung
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Geschätzt)
90
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Gözde Gökçe İsbir
- Telefonnummer: +905057782319
- E-Mail: gozdegokce@gmail.com
Studieren Sie die Kontaktsicherung
- Name: Zehra Yıldırım
- Telefonnummer: +905464313760
- E-Mail: ebezehrayldrm@gmail.com
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Ja
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
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-Komparator: 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Psychological Well-Being
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
1. Oktober 2026
Primärer Abschluss (Geschätzt)
1. November 2026
Studienabschluss (Geschätzt)
15. Februar 2027
Studienanmeldedaten
Zuerst eingereicht
7. Juli 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
7. Juli 2026
Zuerst gepostet (Tatsächlich)
13. Juli 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
14. Juli 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
11. Juli 2026
Zuletzt verifiziert
1. Juli 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
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