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IRCT20251214068337N1 IRCT 2026-03-28 Islamic Azad University The effectiveness of Leventhal model self regulation on the severity of premenstrual syndrome symptoms The effectiveness of self regulation training based on Leventhal's model on the severity of premenstrual syndrome symptoms in nursing students 2026-02-14 anticipated 78 Recruiting https://irct.ir/trial/88160 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: This study consists of two groups: an intervention group and a control group. Only participants in the intervention group will receive the educational intervention, Randomization description: Participants will be randomly assigned to the intervention and control groups using a simple randomization method with a 1:1 allocation ratio. To generate the random sequence, a numbered list of potential participants will first be created. Then, a random number will be generated for each participant using the RAND function in Microsoft Excel. After generating the random numbers, the list will be sorted in ascending order, and based on the new order, participants will be alternately assigned to the intervention and control groups to maintain a 1:1 allocation ratio. To ensure allocation concealment, codes will be prepared and placed in opaque, sealed, sequentially numbered envelopes. After confirming the eligibility of each participant, the researcher will open the next envelope in sequence and assign the participant to the group indicated by the code inside the envelope (intervention or control). N/A pre menstrual syndrome. Intervention 1: The intervention group will receive group-based training based on Leventhal’s Self‑Regulation Model in four weekly sessions, each lasting 60–90 minutes. The content of the training sessions will include introduction to illness perception, identification and modification of maladaptive beliefs related to Premenstrual Syndrome ( PMS), cognitive restructuring, emotion regulation training, bodily awareness, practice of coping skills, and development of an individualized PMS symptom management plan. The sessions will be conducted by the researcher. In addition to receiving the training, participants will be assigned homework, including daily symptom monitoring, relaxation exercises, and implementation of a self‑care plan. . Intervention 2: Control group: The control group will not receive any educational intervention during the study period. After the completion of data collection, a single intensive educational session will be offered to them if they wish to participate. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No additional information is available
public Maryam Farmahini Farahani
No. 1, Asman Alley, Zare’ St., jadidi St., Emamat Sq., Tehran, Iran, 3rd Floor
Tehran Iran (Islamic Republic of) 1743634314 +98 21 7740 2465 maryamfarahani1354@yahoo.com Islamic Azad University scientific Maryam Farmahini Farahani
No. 1, Asman Alley, Zare’ St., Jadidi St., Emamat Sq, Tehran, Iran
Tehran Iran (Islamic Republic of) 1743634314 +98 21 7740 2465 maryamfarahani1354@yahoo.com Islamic Azad University Iran (Islamic Republic of) Having a regular menstrual cycle in the last 6 months unmarried (single status) Presence of moderate to severe premenstrual syndrome (PMS) symptoms Normal Body Mass Index (BMI) Access to a smartphone and the internet ( for following) 18 years 35 years Female History or presence of gynecological diseases or previous gynecological surgery Diagnosis of psychiatric disorders Use of sedative or psychotropic medications Alcohol consumption or tobacco use Presence of vaginal infection Exposure to severe stressful life events (e.g., death of a close family member) within the past three months N94.3 Premenstrual tension syndrome Lifestyle Lifestyle The intervention group will receive group-based training based on Leventhal’s Self‑Regulation Model in four weekly sessions, each lasting 60–90 minutes. The content of the training sessions will include introduction to illness perception, identification and modification of maladaptive beliefs related to Premenstrual Syndrome ( PMS), cognitive restructuring, emotion regulation training, bodily awareness, practice of coping skills, and development of an individualized PMS symptom management plan. The sessions will be conducted by the researcher. In addition to receiving the training, participants will be assigned homework, including daily symptom monitoring, relaxation exercises, and implementation of a self‑care plan. . Control group: The control group will not receive any educational intervention during the study period. After the completion of data collection, a single intensive educational session will be offered to them if they wish to participate Severity score of premenstrual syndrome symptoms in the Siah bazi questionnaire. Timepoint: The severity of premenstrual syndrome is measured at baseline before the training, immediately after the training, and 8 weeks after the completion of the training. Method of measurement: Premenstrual Symptoms Screening Tool (Siah bazi). Islamic Azad University Approved 2025-11-17 Ethics Committee of the Faculty of Medicine, Tehran Islamic Azad University of Medical Sciences Third Floor, Research and Technology Office, Headquarters Building, Islamic Azad University of Medical Sciences, Tehran, Corner of Gol Yakh Street, Ayeneh Boulevard, Amir Pabarja Street, Gholhak Junction, Dr. Shariati Street, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)