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IRCT20241212064031N1 IRCT 2025-08-07 Shiraz University of Medical Sciences the effect of psychological training on maternal mental health during pregnancy Fear of Chidbirth (FoC) Effectiveness of schema training and emotional coaching on fear of childbirth, emotional regulation and self-compassion among pregnant women 2025-07-06 anticipated 60 Complete https://irct.ir/trial/80724 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Blocked Randomization:Participants are randomly assigned to three groups — control, schema therapy training, and emotion coaching training — using blocked randomization with a fixed block size of 20, Blinding description: The pregnant mothers were unaware of the group to which they were assigned (control, schema therapy training, or emotion coaching), but the researchers and intervention facilitators were aware of the group allocations. N/A Fear of childbirth Emotion dysregulation Low self-compassion. Intervention 1: Intervention group: Schema-Based Training Number of sessions: 10 sessions, each one hour long, held weekly Educational content: Introduction to schemas, identification of maladaptive schemas, training on techniques for schema modification, and strengthening of healthy schemas Delivery method: Online sessionsTeaching methods: Theoretical instruction, practical exercises, and homework assignments. Intervention 2: Intervention group: Emotion-Focused Coaching Number of sessions: 10 sessions, each one hour long, held weeklyEducational content: Training on emotion regulation skills, recognition and acceptance of emotions, enhancing self-compassion, and providing coping strategiesDelivery method: Sessions conducted either online or in personTeaching method: A combination of theoretical instruction, practical exercises, and individual feedback. Intervention 3: Control group: This group does not receive any educational intervention and only receives routine care provided by the health centers. Yes - There is a plan to make this available What will be shared: After study completion, de-identified individual data, including demographic information and primary and secondary outcomes, will be uploaded to a secure data repository. Sharing may be limited to a subset of data if necessary. Access will be granted upon formal request and ethics committee approval, with strict confidentiality maintained. When: The data and documents will be made available in a public repository after the completion of the study, final analysis, and publication of primary results. They will remain accessible for at least five years following publication. Access requests within this timeframe require formal application and ethics committee approval. To whom: Access to the data and documents will be granted to qualified researchers who submit a formal request along with a research proposal and receive approval from the ethics committee. Access will be provided in compliance with confidentiality and ethical standards. Conditions: De-identified individual participant data and related documents will be used solely for scientific research and knowledge advancement. Any commercial use, re-identification of participants, or unauthorized data sharing/publication is strictly prohibited. Conditions for Requesting and Using Data: Submission of a formal request and research proposal detailing the objectives and analysis methods Approval by the relevant ethics committee Guarantee of data confidentiality and security by the requester Respect for intellectual property rights and proper citation in any dissemination or publication Analyses limited to the approved objectives, with no use beyond without additional permission These measures are established to protect participant privacy and ensure ethical and responsible use of the data. Where to obtain: Applicants wishing to obtain data and documents related to this study can do so through the following methods: Email contact: Official email of the principal investigator: z.97asghari@gmail.com (Please include the subject of your request, research purpose, and your contact information in the email.) Phone contact: Phone number: +98 913 294 1625 Availability: Saturday to Wednesday, 9 AM to 5 PM Contact person: Zahra Asghari Postal correspondence: Mailing address: Shiraz University of Medical Sciences Postal code: 7113613851 Shiraz, Iran How to obtain: The applicant must submit a formal request along with a research proposal. The request will be reviewed, and after approval by the ethics committee and signing a confidentiality agreement (if required), the de-identified data and documents will be prepared and sent. The entire process typically takes between 4 to 8 weeks. Comments:
public Zahra Asghari
"Ladbaestan Building, opposite Dr. Farvardin Eye Clinic, between Mollasadra St. and Baghshah St., Ma’adal Gharbi St.
Shiraz Iran (Islamic Republic of) 7134686499 +98 913 294 1625 z.97asghari@gmail.com Islamic Azad University scientific Zahra Asghari
"Ladbaestan Building, opposite Dr. Farvardin Eye Clinic, between Mollasadra St. and Baghshah St., Ma’adal Gharbi St.
Shiraz Iran (Islamic Republic of) 7134686499 +98 31 3267 0726 z.97asghari@gmail.com Islamic Azad University Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Minimum education of high school diploma for pregnant women Willingness to participate in the study and group mental education program Psychological dignosis of fear of childbirth (FOC) Women in their third trimester of pregnancy No previous experience of labor no limit no limit Female Absence from more than two sessions during the training phase Preeclampsia Gestational hypertension Placenta previa A prior diagnosis of psychotic disorders and chronic mental illnesses Gestational diabetes Polyhydramnios Behavior Behavior N/A Intervention group: Schema-Based Training Number of sessions: 10 sessions, each one hour long, held weekly Educational content: Introduction to schemas, identification of maladaptive schemas, training on techniques for schema modification, and strengthening of healthy schemas Delivery method: Online sessionsTeaching methods: Theoretical instruction, practical exercises, and homework assignments Intervention group: Emotion-Focused Coaching Number of sessions: 10 sessions, each one hour long, held weeklyEducational content: Training on emotion regulation skills, recognition and acceptance of emotions, enhancing self-compassion, and providing coping strategiesDelivery method: Sessions conducted either online or in personTeaching method: A combination of theoretical instruction, practical exercises, and individual feedback Control group: This group does not receive any educational intervention and only receives routine care provided by the health centers. Score of childbirth fear in Wijma Delivery Expectancy Questionnaire (W-DEQ Version A)Childbirth fear is assessed using the W-DEQ Version A (33 items, six-point Likert scale). Timepoint: Childbirth fear score: Measured at two time points: before the intervention begins and immediately after the completion of the training program. Method of measurement: Wijma Delivery Expectancy Questionnaire Version A, consisting of 33 items with a six-point Likert scale. Score of emotion regulation strategies in Cognitive Emotion Regulation Questionnaire (CERQ)Cognitive emotion regulation is measured using the CERQ (18 items, nine subscales, five-point Likert scale). Timepoint: Emotion regulation score: Assessed at two time points: pre-intervention and immediately post-intervention. Method of measurement: Cognitive Emotion Regulation Questionnaire, consisting of 18 items and 9 subscales with a five-point Likert scale. Score of self-compassion in Self-Compassion Scale (SCS)Self-compassion is evaluated through the SCS (26 items, six subscales, five-point Likert scale). Timepoint: Self-compassion score: Evaluated at two time points: before the intervention and after the intervention ends. Method of measurement: Self-Compassion Scale, consisting of 26 items and 6 components with a five-point Likert scale. Shiraz University of Medical Sciences Approved 2024-12-11 Ethics Committee of Islamic Azad University, Shiraz Branch Ladbaestan Building, opposite Dr. Farvardin Eye Clinic, between Mollasadra St. and Baghshah St., Ma’adal Gharbi St., Shiraz, Iran. Shiraz Fars Iran (Islamic Republic of)