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IRCT20180607040000N2 IRCT 2021-11-28 Iran University of Medical Sciences The effectiveness of mindfulness training on premenstrual syndrome The effectiveness of mindfulness training with “mindfulness coach ”mobile app on increasing the quality of life and reducing the symptoms of people with premenstrual syndrome 2021-10-20 anticipated 80 Complete https://irct.ir/trial/59924 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The sample members are selected by simple randomization method through the rand function of Excel software. In this way, with using the analysis ToolPak plugin, which is responsible for analyzing data using statistical techniques, using the Random Number Generation option and then placing the required parameters related to the production of a random number such as (number of variables, number of random numbers, statistical distribution, parameters The desired distribution random seed) and the selection of the discrete distribution (uniform distribution) will produce random or natural random numbers. Based on this, Excel software automatically assigns the sample members to the two groups of the research in a completely random way. N/A premenstrual syndrome/Premenstrual tension syndrome. Intervention 1: Intervention group: This group receives mindfulness training. Initially, 2 training sessions will be held via Skype, in which the concepts related to mindfulness and how to use it by the software will be taught, then the participants will be asked to do at least 15 minutes of exercises specified in the software for 8 weeks a day. The content of 8 software sessions is: Week 1: mindful eating exercise (Audio); your experience of mindful eating; body scan exercise (audio); your experience of body scanning; first week lesson; homework. Week 2: breathing with mindfulness; meditation situations (video); acoustic breathing awareness training; remembering and forgetting; four important skills; second week lesson; homework. Week 3: mindfulness of body movement; practice to the point of endurance; conscious mind stretching movements (audio and video); audio breathing practice in three steps; physical barometer; approach and avoidance; homework. Week 4: managing reactions; learn the answer instead of the reaction; conscious mind walking (audio); what is anxiety? mindfulness of breathing and body (audio); mindfulness of sounds and thoughts (audio); inevitable consciousness (audio); attention with valve activity; homework. Week 5: accept all experiences; resilience; practicing companionship with unpleasant emotions (audio); be kind to yourself; practice breathing in three steps; homework. Week 6: give meaning; mindfulness and mental production; the conscious connection of the mind with thoughts; mindfulness with thoughts (audio); three ways to deal with distress; useless thought pattern; using breathing exercises to counteract thoughts; homework. Week 7: take good care of yourself; apply breathing exercises and choose a practical step; act mindfully; anxiety indicators and practical strategies; energizing and debilitating activities; homework. Week 8: living with the mindfulness, stay mindful, 21 keep mindfulness exercises to mindfulness in the workplace. Intervention 2: Control group: did not receive any treatment interventions and were merely put on the waiting list. 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 more information.
public Komeil Zahedi Tajrishi
No. 1, Shahid Mansouri Street, Niyayesh Street, Satarkhan Avenue
Tehran Iran (Islamic Republic of) ۱۴۴۵۶۱۳۱۱۱ +98 21 6655 1657 zahedi.komeil@gmail.com Iran University of Medical Sciences scientific Komeil Zahedi Tajrishi
No. 1, Shahid Mansouri Street, Niyayesh Street, Satarkhan Avenue
Tehran Iran (Islamic Republic of) ۱۴۴۵۶۱۳۱۱۱ +98 21 6655 1657 zahedi.komeil@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Minimum age 25 years and maximum 45 years Higher education than diploma Moderate to severe premenstrual syndrome (based on PSST questionnaire) Having regular menstruation (intervals between two menstrual periods 33-28 days and bleeding duration between 2 to 7 days) Achieving a score less than or equal to 23 in the general health questionnaire (based on the GHQ-28 questionnaire, a score of 23 or lower is a sign of health) Access to the internet and smartphone 25 years 45 years Female Suffering any menstrual disorders in the 3 months before the study Participating in other studies Undergoing any type of medication to alleviate the symptoms of PMS Suffering physical and Mental Illness Using Self-Reporting Questionnaire and General Health Questionnaire (GHQ-28) N94.3 Premenstrual tension syndrome Treatment - Other N/A Intervention group: This group receives mindfulness training. Initially, 2 training sessions will be held via Skype, in which the concepts related to mindfulness and how to use it by the software will be taught, then the participants will be asked to do at least 15 minutes of exercises specified in the software for 8 weeks a day. The content of 8 software sessions is: Week 1: mindful eating exercise (Audio); your experience of mindful eating; body scan exercise (audio); your experience of body scanning; first week lesson; homework. Week 2: breathing with mindfulness; meditation situations (video); acoustic breathing awareness training; remembering and forgetting; four important skills; second week lesson; homework. Week 3: mindfulness of body movement; practice to the point of endurance; conscious mind stretching movements (audio and video); audio breathing practice in three steps; physical barometer; approach and avoidance; homework. Week 4: managing reactions; learn the answer instead of the reaction; conscious mind walking (audio); what is anxiety? mindfulness of breathing and body (audio); mindfulness of sounds and thoughts (audio); inevitable consciousness (audio); attention with valve activity; homework. Week 5: accept all experiences; resilience; practicing companionship with unpleasant emotions (audio); be kind to yourself; practice breathing in three steps; homework. Week 6: give meaning; mindfulness and mental production; the conscious connection of the mind with thoughts; mindfulness with thoughts (audio); three ways to deal with distress; useless thought pattern; using breathing exercises to counteract thoughts; homework. Week 7: take good care of yourself; apply breathing exercises and choose a practical step; act mindfully; anxiety indicators and practical strategies; energizing and debilitating activities; homework. Week 8: living with the mindfulness, stay mindful, 21 keep mindfulness exercises to mindfulness in the workplace. Control group: did not receive any treatment interventions and were merely put on the waiting list. Physical symptoms of premenstrual syndrome. Timepoint: Before intervention, After intervention. Method of measurement: The Iranian version of the premenstrual symptoms screening tool (PSST); by answering question 14. Emotional symptoms of premenstrual syndrome. Timepoint: Before intervention, After intervention. Method of measurement: The Iranian version of the premenstrual symptoms screening tool (PSST); by answering questions 1,2,3,4,13. Behavioral symptoms of premenstrual syndrome. Timepoint: Before intervention, After intervention. Method of measurement: The Iranian version of the premenstrual symptoms screening tool (PSST); by answering questions 5-12. Quality of life. Timepoint: Before intervention, After intervention. Method of measurement: 12-Item short form survey health-related quality of life questionnaire(SF-12). Iran University of Medical Sciences Approved 2021-10-18 Ethics committee of Iran University of Medical Sciences Shahid Hemmat Highway, Tehran Tehran Tehran Iran (Islamic Republic of)