Determining the effect of self-regulation training based on the Leventhal model on the severity of Premenstrual Syndrome (PMS) Symptoms
Design
A randomized controlled clinical trial will be conducted on 78 nursing students, who will be randomly allocated to intervention and control groups using computer-generated randomization with a 1:1 allocation ratio
Settings and conduct
This study is conducted at the School of Nursing and Midwifery, Tehran Islamic Azad University of Medical Sciences. Seventy-eight students are randomly allocated to intervention and control groups using computer-generated randomization (1:1). The intervention group receives Leventhal’s self-regulation training, while the control group receives no education. Data are collected at baseline, immediately post-intervention, and 8 weeks later.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Regular menstrual cycles during the past 6 months; being single; presence of moderate to severe PMS ; normal Body Mass Index
Exclusion criteria:
History of gynecological diseases; diagnosed psychiatric disorders; use of psychiatric medications; alcohol or tobacco use; presence of vaginal infection; and exposure to major stressful life events (e.g., death of a close relative) within the past three months.
Intervention groups
The intervention group will receive Leventhal’s self-regulation training in four weekly 60-minute sessions, while the control group will not receive any training. The content of the sessions includes introducing illness perceptions, identifying and modifying maladaptive beliefs, teaching emotion regulation, practicing coping skills, and designing an individualized symptom -management plan.
Main outcome variables
Severity of premenstrual syndrome
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20251214068337N1
Registration date:2026-03-28, 1405/01/08
Registration timing:registered_while_recruiting
Last update:2026-03-28, 1405/01/08
Update count:0
Registration date
2026-03-28, 1405/01/08
Registrant information
Name
maryam Farmahini Farahani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7740 2465
Email address
mfarahani@iautmu.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-02-14, 1404/11/25
Expected recruitment end date
2027-06-19, 1406/03/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of self regulation training based on Leventhal's model on the severity of premenstrual syndrome symptoms in nursing students
Public title
The effectiveness of Leventhal model self regulation on the severity of premenstrual syndrome symptoms
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
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)
Exclusion criteria:
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
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Randomized
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)
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
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
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the Faculty of Medicine, Tehran Islamic Azad University of Medical Sciences
Street address
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
City
Tehran
Province
Tehran
Postal code
1949635881
Approval date
2025-11-17, 1404/08/26
Ethics committee reference number
IR.IAU.TMU.REC.1404.399
Health conditions studied
1
Description of health condition studied
pre menstrual syndrome
ICD-10 code
N94.3
ICD-10 code description
Premenstrual tension syndrome
Primary outcomes
1
Description
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)
Secondary outcomes
empty
Intervention groups
1
Description
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. .
Category
Lifestyle
2
Description
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
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Nursing and Midwifery, Tehran Islamic Azad University of Medical Sciences
Full name of responsible person
Fatemeh Habashi
Street address
Farhangegan Hospital, Hesarak direction, University Square, North end of Shahid Sattari Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1477899679
Phone
+98 21 4486 7262
Email
Farhikhteganhospital@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Masoud Parsania
Street address
3rd Floor, Research and Technology Office, Headquarters Building, Islamic Azad University of Medical Sciences, Tehran, Shariati St., Gholhak Junction, Pabarja St., Abneh Blvd., Corner of Gol Yakh St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2264 0599
Email
pezeshkitehran.8@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?