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IRCT20250702066335N1 IRCT 2025-11-07 Tehran University of Medical Sciences Family Education to Reduce Caregiver Stress in Epilepsy The Effect of a Family-Centered Empowerment Program on Care Burden and Anxiety of Primary Caregivers of Patients with Epilepsy 2025-08-06 anticipated 68 Complete https://irct.ir/trial/84693 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, simple individual randomization with a 1:1 allocation ratio between the intervention and control groups was applied. Before participant recruitment, an independent statistician (not involved in recruitment, intervention delivery, or outcome assessment) generated the random allocation sequence using the RAND function in Microsoft Excel. For each participant, a random number between 0 and 1 was produced; values below 0.5 were assigned to the intervention group, and values equal to or above 0.5 were assigned to the control group. The unit of randomization was each individual participant. The final allocation list was password-protected and accessible only to the statistician. To ensure allocation concealment, the researcher responsible for participant enrollment had no access to the random sequence or future assignments. After confirming eligibility, the statistician disclosed each assignment sequentially via confidential email or secure phone call. This procedure ensured complete randomization integrity and allocation concealment, Blinding description: This is a single-blind randomized clinical trial. Only the outcome assessors are blinded to group allocation and are not aware of which participants are in the intervention or control groups. Participants and care providers are not blinded due to the nature of the intervention (a family-centered care program delivered via WhatsApp). Data collectors are not involved in outcome evaluation. The principal investigator and data analysts are aware of group assignments. N/A Epilepsy. Intervention 1: Intervention group: The intervention group received a structured problem-solving coping skills training program designed to support family caregivers of patients with epilepsy in managing caregiver burden and anxiety. Four in-person sessions were conducted over two weeks (two sessions per week, each lasting 60 minutes) at the Tehran Epilepsy Association. The sessions included lectures, group discussions, question-and-answer, and role-playing, supported by educational slides and booklets. The training content covered understanding epilepsy and its complications, methods of patient support, stress management, and information about medications. To enhance effectiveness and interaction, a WhatsApp group was created including study participants and the research team. Participants completed baseline assessments of caregiver burden and anxiety via online links prior to the intervention. Intervention 2: Control group: The control group received only routine care without any structured educational intervention during the study. Baseline assessments of caregiver burden and anxiety were collected using the same standardized questionnaires as in the intervention group. After completion of the study, all educational materials were provided to the control group. Yes - There is a plan to make this available What will be shared: Title: De-identified Participant Data on Anxiety and Caregiver Burden Details: This includes pre- and post-intervention scores on the Spielberger State-Trait Anxiety Inventory and the Novak & Guest Caregiver Burden Inventory. All data are anonymized and do not contain any personally identifiable information. When: The data will become available 6 months after the publication of the thesis or main article and will remain accessible for up to 3 years. To whom: Data will be available to academic researchers affiliated with recognized institutions and organizations who submit a justified scientific request. Conditions: Access will be granted to researchers who provide both ethical approval and a scientifically sound proposal for secondary analysis. The data will be shared exclusively for non-commercial, academic research purposes. All requests will be reviewed by the principal investigator in coordination with the institutional ethics committee. Where to obtain: Requests should be directed to: Name: Sepideh Beyrami Affiliation: Tehran University of Medical Sciences Email: Sepideh.beyrami1997@gmail.com Phone: +98 9338143765 Address: School of Nursing and Midwifery, Valiasr Street, Tehran University of Medical Sciences, Tehran, Iran How to obtain: The applicant must submit a formal request via email, including a brief description of the study, ethical approval, and justification for data use. The review process may take up to 4 weeks, after which the applicant will be notified by email. Comments: None
public Sepideh Beyrami
No. 97, School of Nursing and Midwifery, Tehran University of Medical Sciences, Bozorgmehr Street, Valiasr Avenue, Tehran, Iran. Postal code: 1419733171.
Tehran Iran (Islamic Republic of) 1419733171 +98 933 814 3765 Sepideh.beyrami1997@gmail.com Tehran University of Medical Sciences scientific Sepideh Beyrami
No. 97, School of Nursing and Midwifery, Tehran University of Medical Sciences, Bozorgmehr Street, Valiasr Avenue, Tehran, Iran. Postal code: 1419733171.
Tehran Iran (Islamic Republic of) 1419733171 +98 933 814 3765 Sepideh.beyrami1997@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) First-degree or second-degree relative of a patient with epilepsy At least 6 months of caregiving experience Ability to read and write Access to a smartphone and social networks Age above 18 years Ability to use a VPN to access WhatsApp 18 years 65 years Both Caregivers who are not available at the time of enrollment Caregivers with a known serious psychiatric or physical illness Caregivers who are unable to give informed consent Caregivers experiencing a major stressful life event shortly before enrollment Caregivers with a history of non-adherence in similar studies Any condition that, in the opinion of the research team, makes participation unsafe or unfeasible G40 Epilepsy and recurrent seizures Behavior Behavior Intervention group: The intervention group received a structured problem-solving coping skills training program designed to support family caregivers of patients with epilepsy in managing caregiver burden and anxiety. Four in-person sessions were conducted over two weeks (two sessions per week, each lasting 60 minutes) at the Tehran Epilepsy Association. The sessions included lectures, group discussions, question-and-answer, and role-playing, supported by educational slides and booklets. The training content covered understanding epilepsy and its complications, methods of patient support, stress management, and information about medications. To enhance effectiveness and interaction, a WhatsApp group was created including study participants and the research team. Participants completed baseline assessments of caregiver burden and anxiety via online links prior to the intervention. Control group: The control group received only routine care without any structured educational intervention during the study. Baseline assessments of caregiver burden and anxiety were collected using the same standardized questionnaires as in the intervention group. After completion of the study, all educational materials were provided to the control group. Caregiver burden measured by the Novak & Guest Caregiver Burden Inventory. This is a primary outcome variable. Timepoint: Before intervention (baseline), and 4 weeks after intervention. Method of measurement: Caregiver burden will be quantified using the Novak & Guest Caregiver Burden Inventory, a standardized questionnaire assessing multiple burden dimensions (time-dependence, developmental, physical, social, emotional). Scores will be computed according to the instrument manual. State anxiety of caregivers measured by the Spielberger State-Trait Anxiety Inventory (state subscale). This is a primary outcome variable. Timepoint: Before intervention (baseline), and 4 weeks after intervention. Method of measurement: State anxiety will be measured using the state subscale of the Spielberger State-Trait Anxiety Inventory (STAI-S), a validated self-report instrument. Scores are calculated per the STAI manual. Trait anxiety of caregivers measured by the Spielberger State-Trait Anxiety Inventory (trait subscale). This is a primary outcome variable. Timepoint: Before intervention (baseline), and 4 weeks after intervention. Method of measurement: Trait anxiety will be measured using the trait subscale of the Spielberger State-Trait Anxiety Inventory (STAI-T). Scores are calculated according to the STAI manual. Tehran University of Medical Sciences Approved 2022-12-26 Ethics Committee of Ethics Committees of School of Nursing & Midwifery & Rehabilitation, TUMS Address: 4th Floor, Central Building, Tehran University of Medical Sciences, Ghods Street and Keshavarz Blvd Intersection, Tehran, Iran Affiliated with: School of Nursing and Midwifery & School of Rehabilitation, Tehran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)