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IRCT20241201063904N1 IRCT 2025-02-17 Torbate-Heidaria University of Medical Sciences Auriculotherapy The effect of auriculotherapy on the severity of premenstrual syndrome symptoms, anxiety and quality of life of women: Double-blind randomized clinical trial 2025-01-20 anticipated 70 Complete https://irct.ir/trial/80840 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: In this study, the participants were randomly assigned to two intervention and control groups. Allocation of groups was done using random.org software. Randomization and allocation of groups was done by a person who was unaware of the groups. The interventionists and data analysts are unaware of the random assignment, Blinding description: In the present study, a double-blind methodology was employed. To ensure blinding, both the intervention implementers and the data analysts were blinded to the random allocation and group assignment of the study participants. Furthermore, the participants themselves were unaware of their group assignment and the type of intervention they received. To maintain blinding, a third party was utilized to perform group allocation and oversee the assignment process; the group codes were retained until the end of the study, following the completion of all stages. N/A premenstrual syndrome. Intervention 1: Intervention group: Auriculotherapy is performed once a week for four weeks during a monthly menstrual cycle (except for seven days of menstrual bleeding), starting seven days before the start of menstrual bleeding. Intervention 2: Control group: The pressure of false ear points (placebo group) is performed once a week for four weeks during a menstrual cycle. Yes - There is a plan to make this available What will be shared: Scientific documentation: includes research articles, technical reports, and conference presentations. Research data: raw data, processed data, and meta data. When: Immediately after accessing the data To whom: Principal investigators of the study Colleagues in other institutions Judges and review authorities Magazine reviewers Complementary medicine colleagues Help of researchers Students of the University of Medical Sciences Participants in conferences and seminars Future researchers: Access after verification: Access request system Conditions: The following are considered for access: Open Licenses / Restricted Licenses / Data Content / General Information / Sensitive data/purposes of use/scientific and research use/commercial use Assurance of attribution/crediting/compliance with laws: Local and international laws/ agreements/ partnership agreements/ technical conditions Accessibility Where to obtain: Researchers and authors of articles: Libraries and research centers: Online databases Governmental and non-governmental organizations: Research organizations: Conferences and seminars: Document preview: Research groups How to obtain: Need identification: Goal definition: Identify sources: Application preparation: Submit request Application review: Get the answer: Usage and reporting: Feedback and follow-up: Comments:
public Seyedeh Zahra Hoseini Haji
Torbat Heydarieh University of Medical Sciences
Mashhad Iran (Islamic Republic of) 9519633787 +98 51 5242 0128 zarhoseinihh@gmail.com Torbate-Heidaria University of Medical Sciences scientific Mohammad Eghbali
Torbat Heydarieh University of Medical Sciences
Mashhad Iran (Islamic Republic of) 9519633787 +98 51 5242 0128 eghbali.msn@gmail.com Torbate-Heidaria University of Medical Sciences Iran (Islamic Republic of) Presence of moderate to severe premenstrual syndrome according to the premenstrual syndrome instrument age 35-18 years Iranian nationality having regular menstrual cycles with equal intervals (22-35 days) no history of psychological diseases , chronic diseases and depression based on the DASS21 questionnaire no use of antidepressants, sedatives and hormonal drugs no mass, infection or scar on the external ear 18 years 35 years Female pregnancy Diagnosis of secondary dysmenorrhea (due to causes such as cyst, fibroid or endometriosis) not attending all sessions Regular auriculotherapy (more than two absent sessions) failure to complete the premenstrual syndrome symptom registration table receiving another treatment method to improve premenstrual syndrome (medicine, herbal therapy, hormonal therapy) F38.8 Other specified mood [affective] disorders Treatment - Other Placebo Intervention group: Auriculotherapy is performed once a week for four weeks during a monthly menstrual cycle (except for seven days of menstrual bleeding), starting seven days before the start of menstrual bleeding. Control group: The pressure of false ear points (placebo group) is performed once a week for four weeks during a menstrual cycle. Severity of premenstrual syndrome. Timepoint: Collecting information in four time stages: the beginning of the intervention (T1), after the first cycle of the intervention (fifth week) (T2), after the second cycle of the intervention (ninth week) (T3) and follow-up one month later in the 13th week after the start of the intervention (T4). Method of measurement: premenstrual syndrome screening questionnaire (PSST). Anxiety. Timepoint: The beginning of the intervention (T1), after the first cycle of the intervention (fifth week) (T2), after the second cycle of the intervention (ninth week) (T3) and follow-up one month later in the 13th week after the start of the intervention (T4). Method of measurement: DASS21 questionnaire. Quality of life. Timepoint: The beginning of the intervention (T1), after the first cycle of the intervention (fifth week) (T2), after the second cycle of the intervention (ninth week) (T3) and follow-up one month later in the 13th week after. Method of measurement: WHO-QOL questionnaire. Torbate-Heidaria University of Medical Sciences Approved 2025-01-26 Ethics Committee of Torbat Heydarieh University of Medical Sciences Mashhad- Torbat Heydarieh highway. Torbat Heydarieh University of Medical Sciences Mashhad Razavi Khorasan Iran (Islamic Republic of)