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IRCT20190529043754N1 IRCT 2022-03-29 Shahroud University of Medical Sciences The effect of health promoting lifestyle educational program on infertile couple who candidate for Assisted reproductive technology. Determining the effectiveness of a health-promoting lifestyle training program in infertile couples under Assisted Reproductive Technologies (ART). 2022-04-09 anticipated 150 Complete https://irct.ir/trial/58233 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: After primary selection, the samples will be divided into two groups by simple sampling method, using a random block of 4, with an allocation ratio of 1: 1. Then, by listing all the Possible mods of blocks of 4 and assign numbers to each of them, with use computer random numbers with 1:1 allocation ratios, Participants will be divided into two groups of intervention and control. Community Verified icon, Blinding description: The sequence is provided to the researcher by a statistical consultant using a website. Then sealed envelope will be used According to the sequence produced, the blocks are designed and placed in closed envelopes. As soon as the eligible patient enters, the envelopes are opened in order and According to the letter.هside them, they will assigned to one of the groups' treatment or control. Patient information will recorded by the research team. N/A Infertility. Intervention 1: Intervention group: The intervention group will included 75 infertile couples (men and women) undergoing infertility treatments.The training program will be in three dimensions. 1- physical activity: The intervention group will perform physical activity home-based exercise and balanced walking with progressive muscle relaxation. in the end of activity they will do deep diaphragmatic breathing. exercise. Pattern of activity will be 3 times a week, for 45 minutes, In moderate intensity in 8 sessions before the onset of ovulation stimulation. Diet: In the intervention group, nutrition will include adjusting calorie intake based on participants' body mass index classification along with receiving the standard 5 main food groups with Mediterranean diet in 8 sessions before the onset of ovulation stimulation. The food frequency questionnaire will be completed. Stress management: In the intervention group, stress management will be based on the Mindfulness program. Training and counseling sessions will be held in personally and virtually for 8 sessions of 60 minutes, once a week.The content of the sessions begins with an introduction and welcome, then will continue to introduce stress and the mechanism of the effect of stress on the body, familiarity with the reproductive system, causes of infertility and infertility treatment methods. Training in the next sessions will include progressive muscle relaxation, ecstasy, diaphragmatic breathing, self-help, strengthening self-reconciliation, recognizing strengths and weaknesses, problem solving, forgiving oneself and others, compassion for oneself and others, sharing experiences. Training will be done 6 sessions before the onset of ovulation and 2 sessions in the waiting period until the pregnancy test is positive. Pr-test and post-test will perform. Intervention 2: Control group: 75 infertile under treatment couples in the control group will receive lactation education. Yes - There is a plan to make this available What will be shared: The data can be published after the completion of the dissertation When: One year after completing the dissertation To whom: Shahroud University of Medical Sciences; Hospital and university researchers Conditions: Data will be available after publication in journals Where to obtain: Padideh Malekpour padideh_66@yahoo.com Correspondence Address: Shahroud University of Medical Sciences, Hafte Tir Square, Shahroud, Iran Phone: 023-32395054 How to obtain: The information will be available through the publication of the article. But if more information is needed, the request should be sent via email Comments:
public Padideh Malekpour
Shahroud University of Medical Sciences, Hafte Tir Square, Shahroud, Iran
Shahroud Iran (Islamic Republic of) ۳۶۱۴۷-۷۳۹۴۳ 4 +98 23 3234 2000 padideh_66@yaoo.com Shahroud University of Medical Sciences scientific Dr.Zahra Motaghi
Shahroud University of Medical Sciences and Health Service building, Hafte Tir Square,, Shahroud, Iran.
Shahroud Iran (Islamic Republic of) ۳۶۱۴۷-۷۳۹۴۳ +98 23 3239 5054 zhrmotaghi@yahoo.com Shahroud University of Medical Sciences Iran (Islamic Republic of) Interested in participating in the study, Assisted Reproductive Technology candidate couples Could read and write First or second infertility Treatment, 18 years 40 years Both Diagnosed for mental or psychotic disorders Diagnosed for Chronic illnesses N97 Female infertility Lifestyle Lifestyle Intervention group: The intervention group will included 75 infertile couples (men and women) undergoing infertility treatments.The training program will be in three dimensions. 1- physical activity: The intervention group will perform physical activity home-based exercise and balanced walking with progressive muscle relaxation. in the end of activity they will do deep diaphragmatic breathing. exercise. Pattern of activity will be 3 times a week, for 45 minutes, In moderate intensity in 8 sessions before the onset of ovulation stimulation. Diet: In the intervention group, nutrition will include adjusting calorie intake based on participants' body mass index classification along with receiving the standard 5 main food groups with Mediterranean diet in 8 sessions before the onset of ovulation stimulation. The food frequency questionnaire will be completed. Stress management: In the intervention group, stress management will be based on the Mindfulness program. Training and counseling sessions will be held in personally and virtually for 8 sessions of 60 minutes, once a week.The content of the sessions begins with an introduction and welcome, then will continue to introduce stress and the mechanism of the effect of stress on the body, familiarity with the reproductive system, causes of infertility and infertility treatment methods. Training in the next sessions will include progressive muscle relaxation, ecstasy, diaphragmatic breathing, self-help, strengthening self-reconciliation, recognizing strengths and weaknesses, problem solving, forgiving oneself and others, compassion for oneself and others, sharing experiences. Training will be done 6 sessions before the onset of ovulation and 2 sessions in the waiting period until the pregnancy test is positive. Pr-test and post-test will perform. Control group: 75 infertile under treatment couples in the control group will receive lactation education. Primary outcome: Chemical pregnancy by Beta human chronic gonadotrophin (B-hCG) blood test. Timepoint: 4 and 6 week after pregnancy. Method of measurement: Blood test to diagnose pregnancy by (Beta-hCG) test. Clinical pregnancy (diagnosis of fetal heart rate at 6 weeks with ultrasound). Timepoint: Weeks 4 and 6 of pregnancy. Method of measurement: Hearing the sound of the fetal heart during the 6th week of pregnancy by ultrasound. Live Birth. Timepoint: Delivery after 24 week of pregnancy. Method of measurement: Neonate delivered via natural or cesarean. Vice chancellor for research, Shahroud University of medical sciences. Approved 2020-04-20 Ethics Committee of Shahroud University of Medical Sciences Sharoud medical science and health service university, Hafte tir square, Shahroud, Iran. Shahroud Semnan Iran (Islamic Republic of)