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Effect of Web-Based counseling on Premenstrual Syndrome

Effect of Web-Based Counseling with Cognitive-Behavioral Approach on Premenstrual Syndrome: a randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20100414003706N34
Enrollment
92
Registered
2019-06-19
Start date
2019-06-22
Completion date
Unknown
Last updated
2019-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premenstrual Syndrome. Premenstrual tension syndrome

Interventions

Intervention 1: Intervention group: Web-based cognitive-behavior counselling (through the Learning Management System (MOODLE) of Tabriz University of Medical Sciences) including 14 modules over 8 cons

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 35 Years

Inclusion criteria

Inclusion criteria: Healthy women aged 18-35 years Resident in governmental or non-governmental dormitories of Tabriz University of Medical Sciences Regular menstrual periods of 25 to 35 days over the past 6 months Having moderate or severe premenstrual syndrome (PMS) or premenstrual dysphoric disorder (PMDD), based on the DRSP questionnaire filled in two following cycles Good cooperation in filling the questionnaires at the preliminary stage of study (before randomization) Having experience in using Internet Regular access to Internet during study period Having a phone number for follow-up

Exclusion criteria

Exclusion criteria: Being a professional athlete Pregnancy or the first postpartum year Breast-feeding Having severe depression (score 29 or higher on Beck Depression Inventory) Having a history of severe depression, anxiety or eating disorders in the past two years, self-report Drug use or history of drug use during the last two years, self-report Use of antidepressants, benzodiazepines, anticancer drugs, oral contraceptives or hormones in the past three months, self-report Having chronic diseases (such as epilepsy, or severe digestive, cardiovascular, kidney, or gonadal disorders), self-report Occurrence of a very stressful event in the past six months, such as: separation of parents, death of first degree family members, self-report History of major psychiatric disorders (psychosis, bipolar disorder, suicide attempt) Having some gynecological problems (hysterectomy, Ooforectomy, female cancer, polycystic ovary syndrome, endometriosis, infertility)

Design outcomes

Primary

MeasureTime frame
Symptoms of premenstrual syndrome. Timepoint: Daily record of severity of symptoms for two menstrual cycle at two stages, first at the baseline (before randomization) and just after completion of the intervention. Method of measurement: Daily Record of Severity of Problems chart (DRSP).;Quality of life at luteal phase of menstruation. Timepoint: At the first or second day of menstrual cycle at two stages (at the cycle prior to the randomization and at the cycle just after completion of intervention). Method of measurement: Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF).;Quality of life follicular phase of the menstrual. Timepoint: At the 11th-13th day of menstrual cycle at two stages (at the cycle prior to the randomization and at the cycle just after completion of intervention). Method of measurement: Q-LES-Q-SF.

Secondary

MeasureTime frame
Menstrual Attitude. Timepoint: At the first or second day of menstrual cycle at two stages (at the cycle prior to the randomization and at the cycle just after completion of intervention). Method of measurement: Menstrual Attitude Questionnaire.;Patient satisfaction. Timepoint: At the first or second day of the first menstrual cycle just after completion of intervention. Method of measurement: Patient Satisfaction Questionnaire.;Disability. Timepoint: At the first or second day of menstrual cycle at two stages (at the cycle prior to the randomization and at the cycle just after completion of intervention). Method of measurement: Sheehan Disability Scale (SDS).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSanam Borji Navan

Tabriz University of Medical Sciences

Borjisanam@gmail.com+98 13 4422 7002

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 19, 2026