<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20201122049458N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-06-12</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of teaching lifestyle measures of Iranian medicine on the marital satisfaction of couples</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of teaching lifestyle measures of Iranian medicine in premarital counseling centers on the marital satisfaction of couples</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>122</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69848</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Marital Satisfaction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention is carried out on 122 couples who come to Haji Maqsoudi counseling center during three months, who intend to get married and to participate in pre-marriage training courses. The educational content for the workshops is prepared after reviewing the reliable sources of Iranian medicine and the articles available in this field and the consensus of opinion among the Iranian medical experts collaborating in the project, which includes teaching the six principles of maintaining health and a healthy lifestyle from the perspective of Iranian medicine, in In addition, an educational package containing an educational booklet + a video that contains audio-visual training along with the talks of an Iranian medical expert will be delivered to the participants of the project. one week apart) and a workshop using the collaborative method (group discussion, question and answer) will be held two weeks apart from the first two workshops. The maximum capacity of each workshop is 35 couples. The virtual group will remain after the end of the workshop to answer the possible questions of the couples, and the questions about the topics raised will be answered by an Iranian medical expert. Educational content: The six principles of lifestyle, including eating and drinking according to the mood and slowly. Eating and avoiding liquids with meals, sleeping and waking up including the best sleeping hours between 10 pm and 2 am, controlling mental and emotional states, weather conditions according to the person's mood, eliminating waste from the body and eliminating constipation, exercise and rest. According to the person's temperament, educational content: lifestyle factors in Iranian medicine. In this topic, the six lifestyle factors that all humans are exposed to are described under the title "Six Essential Principles for a Healthy Life". The six essential principles are important because all people deal with them on a daily basis and life is impossible without them. The correct management of these cases has been the concern of Iranian traditional medicine scientists for a long time. These six vital principles are: 1. Air and environment 2. Movement and stillness (exercise and rest) 3. Sleep and wakefulness 4. Eating and drinking 5. Disposal of unnecessary materials and preservation of essential materials 6. Pay attention to mental states: the things recommended in this section are taught and applicable to maintain health in healthy people and prevent them from getting sick. 1. Air and environment: One of the most important components of the environment is the air around us. Harmonizing the body with the air in the environment and following its recommendations helps to maintain health. Movement and stillness (exercise and rest): In traditional medicine, movement and stillness are important parts of maintaining health. The best time to exercise is when the weather is mild, so it is around noon in spring, at the beginning of the day in summer, and at the end of the day in winter. But the duration and intensity of exercise should be less in spring and summer, and more in autumn and winter. The time of exercise should be adjusted with the time of eating. Do not exercise when you are hungry because the body needs food in this state. Exercise consumes the same few substances that the body feeds on when it is hungry. You should not exercise immediately after eating, because the digestion of food is not yet complete and the entry of undigested food into the organs will harm the body. It is better that before exercise, the body is cleansed of inappropriate substances and the intestines and bladder are empty of urine and feces. Athletes should not eat heavy or slow-digesting foods two hours before the start of training or competition. 3. Sleep and wakefulness: In traditional medicine, a good sleep in a healthy person has certain conditions, some of which are different in different ages, seasons and temperaments according to the amount of humidity. Therefore, children sleep more than adults, women sleep more than men, and the elderly sleep less. And in winter, due to increasing coldness and humidity, sleep becomes longer. The best sleep duration is 6-10 hours. Of course, the period mentioned is for adults and children and babies need to sleep more than 10 hours a day. Young people need more sleep than old people. From a scientific point of view, the best time to sleep is from early night to early morning (between morning call to prayer and sunrise). This dream gives you vitality and energy. 4. Eating and drinking: Each of the different foods has its own quality and mood. This problem causes the type of food consumed by people to affect their physical and mental characteristics. Food recommendations are expressed with different approaches in traditional medicine. Fast-digesting foods are mostly recommended for people who do not have strong digestion due to illness or who have recently recovered from illness. Examples of these foods include: grilled chicken, chicken soup with well-cooked wheat bread. Slow-digesting foods are suitable for those who do heavy physical activities, such as athletes, farmers, construction workers, and blacksmiths. Because if these people use fast-digesting food, it will quickly decay and they have to use their body's internal energy. Examples of these foods are: hard-boiled or half-boiled eggs, halim, meat, halwa prepared with oil, flour, starch, honey, or sugar, etc. It is better for sedentary people such as students, employees, etc. Managers should not use the above foods. General food recommendations: correct eating habits from the perspective of traditional medicine: 1. To help the proper digestion of food in the digestive system, do not eat before feeling real hunger (honest appetite) and stop eating before feeling full. 2. Observe moderation in eating. That is, don't eat so much that it causes stomach heaviness, discomfort, nausea, etc., and don't eat so little that it causes weakness and loss of body strength.3. Observing the order of eating food and avoiding mixing food is one of the instructions to maintain health. Fast-digesting foods should not be consumed after slow-digesting foods. For example, the habit of eating salad or soup after a meal is very wrong and should be stopped gradually. Preferably eat the salad before the main meal or as a snack. 4. Preferably do not use drinks with food. 5. Take small bites. 6. Chew food well (chew each small bite at least 15 times) 7. Create a calm and cheerful environment while eating and don't eat when angry. 8. Eat calmly and slowly and don't talk while eating. 9. While eating, do not occupy your mind with miscellaneous issues (watching TV, listening to music, reading, etc.). 10. Do not eat food too hot or too cold. 11. Do not eat while standing or moving. 12. Do not exercise or heavy activity immediately after eating. 13. Avoid eating fruit or drinks immediately after meals. 14. Avoid sleeping immediately after eating. 5. Disposing of unnecessary substances from the body and maintaining essential substances in the body: Cleansing the body of toxins and waste substances that are created in the body during the digestion process plays an important role in maintaining human health. Also, maintaining vital and essential substances in the body is important for health. If a person eats enough food but does not have enough stool, urine or sweating, sooner or later he will have a problem. Also, if a person eats enough food but has too much feces, urine or sweat, he will soon have problems. 6. Mental states: The mental state affects all aspects of people's lives. Their effect on the body is faster than the previous 5. To maintain peace and remove mental tensions and emotions, it is useful to follow the following recommendations: Hearts are calmed by the remembrance of God. Strengthen your spiritual relationship with God through worship and prayers and trust him in problems and difficulties. Do not suppress your emotions and emotions and share them with relatives and friends. Laugh at the right time and cry at the right time. Do not be ashamed of crying and do not suppress it. Intervention 2: Control group: They do not receive any training in the field of Iranian medicine.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All data is potentially shareable after de-identifying individuals

When:
The access period starts 6 months after the results are published

To whom:
The data will be publicly available

Conditions:
The data will be publicly available

Where to obtain:
Dr.Monire Seyed Hashemi
m.seiedhashemi@yahoo.com

How to obtain:
After submitting the application, the documents will be sent in less than a month

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Razie Nabi Meybodi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Khomeini Street, Faculty of Traditional Medicine</address>
        <city>Ardekan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8951737915</zip>
        <telephone>+98 35 3223 8916</telephone>
        <email>r.nabimeybodi@ssu.ac.ir</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Monire Seyed Hashemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Farrokhi Street, Shahid Rahnamoun Hospital</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8913814396</zip>
        <telephone>+98 35 3312 2002</telephone>
        <email>m.sesiedhashemi@yahoo.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The couple's first marriage
Obtaining consent to participate in the study</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Failure to participate in training classes</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention is carried out on 122 couples who come to Haji Maqsoudi counseling center during three months, who intend to get married and to participate in pre-marriage training courses. The educational content for the workshops is prepared after reviewing the reliable sources of Iranian medicine and the articles available in this field and the consensus of opinion among the Iranian medical experts collaborating in the project, which includes teaching the six principles of maintaining health and a healthy lifestyle from the perspective of Iranian medicine, in In addition, an educational package containing an educational booklet + a video that contains audio-visual training along with the talks of an Iranian medical expert will be delivered to the participants of the project. one week apart) and a workshop using the collaborative method (group discussion, question and answer) will be held two weeks apart from the first two workshops. The maximum capacity of each workshop is 35 couples. The virtual group will remain after the end of the workshop to answer the possible questions of the couples, and the questions about the topics raised will be answered by an Iranian medical expert. Educational content: The six principles of lifestyle, including eating and drinking according to the mood and slowly. Eating and avoiding liquids with meals, sleeping and waking up including the best sleeping hours between 10 pm and 2 am, controlling mental and emotional states, weather conditions according to the person's mood, eliminating waste from the body and eliminating constipation, exercise and rest. According to the person's temperament, educational content: lifestyle factors in Iranian medicine. In this topic, the six lifestyle factors that all humans are exposed to are described under the title "Six Essential Principles for a Healthy Life". The six essential principles are important because all people deal with them on a daily basis and life is impossible without them. The correct management of these cases has been the concern of Iranian traditional medicine scientists for a long time. These six vital principles are: 1. Air and environment 2. Movement and stillness (exercise and rest) 3. Sleep and wakefulness 4. Eating and drinking 5. Disposal of unnecessary materials and preservation of essential materials 6. Pay attention to mental states: the things recommended in this section are taught and applicable to maintain health in healthy people and prevent them from getting sick. 1. Air and environment: One of the most important components of the environment is the air around us. Harmonizing the body with the air in the environment and following its recommendations helps to maintain health. Movement and stillness (exercise and rest): In traditional medicine, movement and stillness are important parts of maintaining health. The best time to exercise is when the weather is mild, so it is around noon in spring, at the beginning of the day in summer, and at the end of the day in winter. But the duration and intensity of exercise should be less in spring and summer, and more in autumn and winter. The time of exercise should be adjusted with the time of eating. Do not exercise when you are hungry because the body needs food in this state. Exercise consumes the same few substances that the body feeds on when it is hungry. You should not exercise immediately after eating, because the digestion of food is not yet complete and the entry of undigested food into the organs will harm the body. It is better that before exercise, the body is cleansed of inappropriate substances and the intestines and bladder are empty of urine and feces. Athletes should not eat heavy or slow-digesting foods two hours before the start of training or competition. 3. Sleep and wakefulness: In traditional medicine, a good sleep in a healthy person has certain conditions, some of which are different in different ages, seasons and temperaments according to the amount of humidity. Therefore, children sleep more than adults, women sleep more than men, and the elderly sleep less. And in winter, due to increasing coldness and humidity, sleep becomes longer. The best sleep duration is 6-10 hours. Of course, the period mentioned is for adults and children and babies need to sleep more than 10 hours a day. Young people need more sleep than old people. From a scientific point of view, the best time to sleep is from early night to early morning (between morning call to prayer and sunrise). This dream gives you vitality and energy. 4. Eating and drinking: Each of the different foods has its own quality and mood. This problem causes the type of food consumed by people to affect their physical and mental characteristics. Food recommendations are expressed with different approaches in traditional medicine. Fast-digesting foods are mostly recommended for people who do not have strong digestion due to illness or who have recently recovered from illness. Examples of these foods include: grilled chicken, chicken soup with well-cooked wheat bread. Slow-digesting foods are suitable for those who do heavy physical activities, such as athletes, farmers, construction workers, and blacksmiths. Because if these people use fast-digesting food, it will quickly decay and they have to use their body's internal energy. Examples of these foods are: hard-boiled or half-boiled eggs, halim, meat, halwa prepared with oil, flour, starch, honey, or sugar, etc. It is better for sedentary people such as students, employees, etc. Managers should not use the above foods. General food recommendations: correct eating habits from the perspective of traditional medicine: 1. To help the proper digestion of food in the digestive system, do not eat before feeling real hunger (honest appetite) and stop eating before feeling full. 2. Observe moderation in eating. That is, don't eat so much that it causes stomach heaviness, discomfort, nausea, etc., and don't eat so little that it causes weakness and loss of body strength.3. Observing the order of eating food and avoiding mixing food is one of the instructions to maintain health. Fast-digesting foods should not be consumed after slow-digesting foods. For example, the habit of eating salad or soup after a meal is very wrong and should be stopped gradually. Preferably eat the salad before the main meal or as a snack. 4. Preferably do not use drinks with food. 5. Take small bites. 6. Chew food well (chew each small bite at least 15 times) 7. Create a calm and cheerful environment while eating and don't eat when angry. 8. Eat calmly and slowly and don't talk while eating. 9. While eating, do not occupy your mind with miscellaneous issues (watching TV, listening to music, reading, etc.). 10. Do not eat food too hot or too cold. 11. Do not eat while standing or moving. 12. Do not exercise or heavy activity immediately after eating. 13. Avoid eating fruit or drinks immediately after meals. 14. Avoid sleeping immediately after eating. 5. Disposing of unnecessary substances from the body and maintaining essential substances in the body: Cleansing the body of toxins and waste substances that are created in the body during the digestion process plays an important role in maintaining human health. Also, maintaining vital and essential substances in the body is important for health. If a person eats enough food but does not have enough stool, urine or sweating, sooner or later he will have a problem. Also, if a person eats enough food but has too much feces, urine or sweat, he will soon have problems. 6. Mental states: The mental state affects all aspects of people's lives. Their effect on the body is faster than the previous 5. To maintain peace and remove mental tensions and emotions, it is useful to follow the following recommendations: Hearts are calmed by the remembrance of God. Strengthen your spiritual relationship with God through worship and prayers and trust him in problems and difficulties. Do not suppress your emotions and emotions and share them with relatives and friends. Laugh at the right time and cry at the right time. Do not be ashamed of crying and do not suppress it.</i_keyword>
      <i_keyword>Control group: They do not receive any training in the field of Iranian medicine.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Marital satisfaction level based on Enrich Marital Satisfaction Questionnaire. Timepoint: The questionnaire is completed before the start of the training and 3 months after the start of the training. Method of measurement: Enrich Marital Satisfaction Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-03-05</approval_date>
        <contact_name>Shahid Dr. Rahnamon Hospital, Yazd (ethics committee in research)</contact_name>
        <contact_address>Farrokhi Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
