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IRCT20240615062137N1 IRCT 2024-07-08 Islamic Azad University Comparing the effectiveness of the therapeutic package of the components affecting the quality of married life with mindfulness therapy on the quality of marital relationships, emotional dyslexia and their marital adjustment Discovering the factors affecting the quality of life of married women with breast cancer and comparing the effectiveness of the therapy protocol with mindfulness therapy on the quality of marital relationships, alexithymia and their marital adjustment. 2024-10-19 anticipated 60 Complete https://irct.ir/trial/77387 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Block randomization By using the block randomization method by the statistical consultant, randomization is done in 2 groups of training components affecting the quality of married life and mindfulness therapy as follows: First, a list of names of eligible people is provided and coded. In block randomization, the number of participants in all groups will be very close to each other. This is done by making blocks of sequences and intersections so that the same number of participants are assigned to the study groups within each group. First, we code the groups based on Latin letters as follows: A = Teaching the components affecting the quality of married life, B = Mindfulness treatment In this study, with two groups A and B, we create the following two groups and assign numbers 1 to 2 to each of them: -AB-BA Then, using the table of random numbers, we contract that whenever the numbers 1 and 2 appear in order, one of these blocks will be selected, and if another number appears, we will assume it as null and proceed to the next selection. In fact, we have obtained a random sequence of numbers with the table of random numbers, where we consider the order of allocation for each number. In this way, the number of people in the groups will be almost equal. N/A Breast Cancer. Intervention 1: The first intervention group: educational sessions on the factors affecting the quality of marriage will be compiled based on the factors affecting the quality of married life of women with breast cancer. Intervention 2: The second intervention group: cognitive therapy based on mindfulness was taught to the participants with the help of Kabat-Zin training package (2012) in 8 sessions and during one month. Intervention 3: Control group: will not receive any intervention and will be considered as a waiting group. 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 There is no further information
public Zohreh Zadhasan
Amir Mazandarani St, Valiasr 22 Ave
Babolsar Iran (Islamic Republic of) 4741666454 +98 11 3537 3355 zadhasan.zohreh@gmail.com Islamic Azad University scientific Zohreh Zadhasan
Amir Mazandarani St, Valiasr 22 Ave
Babolsar Iran (Islamic Republic of) 4741666454 0981135373355 zadhasan.zohreh@gmail.com Islamic Azad University Iran (Islamic Republic of) Female gender At least ِdiploma education Suffering from breast cancer for at least one year Having no history of neurological and psychological diseases Living in Babol city Having the ability and interest to participate in educational and therapeutic program Informed consent to participate in Research Non-participation in educational classes and methods similar to the intended intervention 30 years 60 years Female Diagnosis of other severe mental or physical illnesses Advanced stages of cancer Concomitant treatments with similar effects Severe marital problems Pregnancy or breastfeeding Drug use or alcohol abuse C50 Malignant neoplasm of breast Treatment - Other Treatment - Other N/A The first intervention group: educational sessions on the factors affecting the quality of marriage will be compiled based on the factors affecting the quality of married life of women with breast cancer. The second intervention group: cognitive therapy based on mindfulness was taught to the participants with the help of Kabat-Zin training package (2012) in 8 sessions and during one month. Control group: will not receive any intervention and will be considered as a waiting group. Quality of marital relations. Timepoint: Pre-test, post-test and follow-up (follow-up period three months later). Method of measurement: Marital Relationship Quality Questionnaire (MMQ). Alexithymia. Timepoint: Pre-test, post-test and follow-up (follow-up period three months later). Method of measurement: Alexithymia scale. Marital Adjustment. Timepoint: Pre-test, post-test and follow-up (follow-up period three months later). Method of measurement: Marital Adjustment Questionnaire. Islamic Azad University Approved 2024-04-03 Ethics committee of Islamic Azad University, Ahvaz Branch First floor office complex- Islamic Azad University Ahvaz Branch- Farhang Shahr- Golestan Highway Ahvaz Khouzestan Iran (Islamic Republic of)