]>
IRCT20240310061242N2 IRCT 2026-03-08 Esfahan University of Medical Sciences Investigating the Effect of Expressive Writing on the Severity of Post-Traumatic Stress. - Investigating the Effect of Expressive Writing on the Severity of Post-Traumatic Stress Disorder in Mothers of Children with Cancer. 2026-01-21 anticipated 76 Complete https://irct.ir/trial/88531 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: -, Randomization description: After obtaining written informed consent, sampling will be conducted using the convenience method. For the random allocation of participants (76 individuals, considering a 10% attrition rate) into two groups of 38 (intervention and control), random numbers will first be generated in SPSS software and sorted using the following commands: Transform → Compute Variable Target Variable: Random Numeric Expression: RV.UNIFORM(0,1) Data → Sort Cases Sort by: Random (Ascending) After sorting, 38 participants will be assigned to the intervention group and 38 to the control group. Based on this, the random sequence of groups (a list of 76 individuals for intervention and control) will be prepared. This sequence will be placed in opaque, sealed, and sequentially numbered envelopes (1 to 76). After the enrollment of each participant, the envelope corresponding to that number will be opened, and their group assignment will be determined. N/A Posttraumatic Stress Disorder. Intervention 1: Intervention group: The intervention consists of expressive writing based on Pennebaker’s guidelines, designed by the researcher under the supervision of the academic advisor. It will be delivered individually and in-person over four consecutive sessions, each lasting at least 45 minutes, and scheduled to align with the child’s hospitalization in the oncology ward. Mothers will participate in the child’s hospital room with appropriate lighting and relative quiet. During the sessions, mothers will be asked to write their thoughts and feelings—including their experience of the child’s cancer diagnosis, the long-term effects of the child’s illness on the mother and family, the importance of finding meaning in difficult experiences, and the integration of identity after crisis—continuously for 15 to 20 minutes per session. The session content will be identical for all participants, and confidentiality of the writing will be emphasized; attention to grammar will not be required. In case of severe anxiety or distress during writing, measures such as temporary pauses or relaxation techniques will be applied. At the end of each session, mothers will be encouraged to discuss their feelings and experiences if they wish. Intervention 2: Control group: No intervention will be administered to this group, and the care provided will be limited to the continuation of their children's routine treatment and standard ward education. At the end of the study, the complete content of the expressive writing sessions will be made available to them, and upon their request, the possibility of conducting similar sessions will be provided. Yes - There is a plan to make this available What will be shared: Shareable data will include de-identified individual participant data obtained from questionnaires (including the PCL-5 and baseline demographic variables), the final study protocol, the statistical analysis plan, and the data dictionary. No personally identifiable or participant-identifying information will be shared. When: Access period starts 6 months after results are published. To whom: Researchers affiliated with recognized academic, research, or clinical institutions. Conditions: The data may be used solely for scientific and research purposes, including secondary analyses, systematic reviews, or meta-analyses. Commercial use is not permitted. Applicants must submit a proposed analysis plan and sign a data confidentiality agreement. Where to obtain: Requests should be submitted to the principal investigator of the study. Contact details will be provided at the time of publication of the study results. How to obtain: After submission of a written request including the study objective and analysis plan, the request will be reviewed by the principal investigator. Upon approval, de-identified data will be shared within 4–6 weeks. Comments: -Data sharing will be conducted in accordance with ethical research principles and the regulations of the ethics committee.
public Fatemeh Ghaedi-Heidari
Nursing and Midwifery Faculty., Isfahan University of Medical Sciences., Hezerjerib Ave., Isfahan
Isfahan Iran (Islamic Republic of) 8174673461 +98 913 601 2502 fatemeh.ghaedi@gmail.com Esfahan University of Medical Sciences scientific Fatemeh Ghaedi-Heidari
Nursing and Midwifery Faculty., Isfahan University of Medical Sciences., Hezerjerib Ave., Isfahan
Isfahan Iran (Islamic Republic of) 8174673461 00998 36687153 fatemeh.ghaedi@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Participants must be fluent in the Persian language and possess basic reading and writing literacy. Participants must have obtained a score of 33 or higher on the Pos-ttraumatic Stress Disorder Checklist (PCL-5) questionnaire. A minimum of two months must have elapsed since the child’s cancer diagnosis. The child must not have concurrent comorbid conditions (e.g., respiratory, cardiac, psychiatric disorders) or congenital anomalies. There must be no other family member with a chronic illness for whom the mother is currently providing care. Based on self-report, participants must not have a diagnosed psychiatric disorder that has resulted in hospitalization or psychotropic medication use. Participants must not have participated in any similar educational or research programs during the same time period or prior to the study. no limit no limit Female Does not have willingness to participate in the study. Incomplete completion of 20% or more of the questionnaires (before randomization) Has experienced severe stressors in the past six months, such as the death of relatives or loved ones, a major stressful event at work, or divorce. F43.1 Post-traumatic stress disorder (PTSD) Behavior Other Intervention group: The intervention consists of expressive writing based on Pennebaker’s guidelines, designed by the researcher under the supervision of the academic advisor. It will be delivered individually and in-person over four consecutive sessions, each lasting at least 45 minutes, and scheduled to align with the child’s hospitalization in the oncology ward. Mothers will participate in the child’s hospital room with appropriate lighting and relative quiet. During the sessions, mothers will be asked to write their thoughts and feelings—including their experience of the child’s cancer diagnosis, the long-term effects of the child’s illness on the mother and family, the importance of finding meaning in difficult experiences, and the integration of identity after crisis—continuously for 15 to 20 minutes per session. The session content will be identical for all participants, and confidentiality of the writing will be emphasized; attention to grammar will not be required. In case of severe anxiety or distress during writing, measures such as temporary pauses or relaxation techniques will be applied. At the end of each session, mothers will be encouraged to discuss their feelings and experiences if they wish. Control group: No intervention will be administered to this group, and the care provided will be limited to the continuation of their children's routine treatment and standard ward education. At the end of the study, the complete content of the expressive writing sessions will be made available to them, and upon their request, the possibility of conducting similar sessions will be provided. The severity score of post-traumatic stress disorder in the post-traumatic stress disorder questionnaire. Timepoint: At three time points: before the start of the intervention, immediately after the completion of the four expressive writing sessions, and one month after the end of the intervention (follow-up). Method of measurement: he severity of post-traumatic stress disorder in mothers of children with cancer will be measured using the Post-Traumatic Stress Disorder Checklist Fifth Edition (PCL-5). Demographic information, including maternal age, education level, occupation, marital status, and other demographic characteristics, will be collected using a demographic information form. Esfahan University of Medical Sciences Approved 2025-12-29 Ethics Committee of School of Nursing, Management and Rehabilitation – Isfahan Medical University Nursing and Midwifery Faculty., Isfahan University of Medical Sciences., Hezerjerib Ave., Isfahan Isfahan Isfehan Iran (Islamic Republic of)