<?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>IRCT20191204045601N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-07-08</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Mindfulness Interventions on the Quality of Sleep in Pregnant Mothers in the second and Third Trimester</public_title>
      <acronym>mfspm</acronym>
      <scientific_title>The Effect of Mindfulness Interventions on the Quality of Sleep in Pregnant Mothers in the second and Third Trimester</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-06-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>84</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/44827</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this study, a sample of 84 pregnant women in the second and third trimesters who refer to Sabzevar health centers will be assigned to study and control groups using closed envelopes and individual lottery. The blocking method is randomly selected by replacing the envelope
Type of randomization: Blocked randomization.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Effectiveness of mindfulness on the quality of sleep of pregnant mothers.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this study, a sample of 84 pregnant women in the second and third trimesters who refer to Sabzevar Health Centers was selected by available sampling method and randomly placed in two experimental and control groups (42 people each). . Upon completion of the pre-test, the 6-session intervention group will be trained in mindfulness exercises and will be given a questionnaire for sleep quality and dass21 questionnaires. And the interview will be conducted by a neuropsychiatrist. Individuals with a score above 5 in the sleep quality questionnaire have poor sleep quality (and, according to the 21dass questionnaire, their severity of moderate to severe depression are in the intervention group. The experimental group will be completed after the mindfulness interventions of the post-test questionnaires. First session: Automatic guidance (When we notice the automatic guidance, we find the presence of the mind) It can be busy; you go from job to job without having a chance to smell a beautiful flower. D or find out what's going on around you. In other words, it's your automatic guide that has control over you. A great way to regain control is to take time for meditation called "Mindfulness of Body and Soul." A simple eight-minute exercise designed to focus on the present. Second session: Focusing more on the body (focusing on the body reveals more mental whispers and leads to more control over the reaction to daily events). It is designed so that you can focus on your body. The body speaks very well. When he says he's hungry, it's almost impossible not to understand what he wants. However, they are a little more nuanced and easy to ignore, and the goal of a 14-minute "body scan" is to open the way for communication between your body and mind. It blows with every breath and with every exhale, it is empty. Pay attention to how you feel while doing this; For example, tingling in the legs or nausea. Remember that there is no winning or losing or failure. If he gets distracted, try to get him back to practice. Do this exercise twice a day for a week. Third session: By learning how the mind can often be busy and scattered, we learn to focus more consciously on breathing to provide more focus and integration. In the third session, it's time to take care of the "three-minute breath" that you have to do twice a day. At this point, take two minutes to focus on your emotions, thoughts, and body, then one minute for deep breathing, and focus on the inhale and exhale. Fourth session: Most often, when the mind wants to focus on something and avoid other things. It is wasted. In the mind-to-face approach to being present at the same time, one must look at events from a different angle in order to have a broad and different view of them. In this session, you should learn how to distance yourself from your thoughts. The meditation you are about to do is called "sounds and thoughts" or "sounds and thoughts": you do nothing for eighty minutes and you only pay attention to the sounds around you. When you realize that sounds come and go like tides, know that you've done the exercise right. When you are fully focused, your mind begins to tell a story based on the sounds you hear; For example, from a loud noise, it is thought that a cement brick has fallen from the roof. This meditation is a great way to learn how your mind works. At the end of the week, you will be much more comfortable with the flow and nature of your thoughts. Or try to change it for what it is. The exercise you do every day for ten minutes a week is called "Searching for Difficulties." Whenever you are ready, turn your thoughts to a difficult or unpleasant subject. Whatever it is; From your childhood illness to your child's poor grades in school. Try to figure out where you feel the thought in your body as soon as you find that point, while taking deep breaths, let those feelings be absorbed. This is the moment of acceptance and compassion that prepares you to be free and comfortable. Combine this meditation with previously learned meditations: "Body and Soul," "Sounds and Thoughts," "Searching for Difficulties," and "Three-Minute Breathing." Understanding that thoughts are just thoughts is reasonable, even for someone who doesn't believe it. This session is about a very general reason, which is another aspect of how to do it. A very general memory is a tendency to recall events from the past in a completely negative way. For example, you may feel awful throughout your high school years, when you really only have an unpleasant class. When you feel this way, you are easily blaming yourself and others. But blaming doesn't help reconcile with the past. In fact, research has shown that it makes it even more difficult. Intervention 2: Control group:  People will be given a sleep quality questionnaire and dass21. And the interview will be conducted by a neuropsychiatrist. People who do not have a problem with sleep quality according to the sleep quality questionnaire (and do not suffer from depression according to the 21dass questionnaire) are in the control group and routine pregnancy care is done for the control group.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is It will be decided after the operation</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Negar Asgharipoor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mashhad Medical Sciences</address>
        <city>sabzavar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948564</zip>
        <telephone>+98 51 3711 2713</telephone>
        <email>asgharipourn@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Negar Asgharipoor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mashhad Medical Sciences</address>
        <city>sabzavar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948564</zip>
        <telephone>+98 51 3711 2713</telephone>
        <email>asgharipourn@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having the ability and interest to participate in educational programs,
not attending similar training classes,
lack of chronic physical illnesses (diabetes, hypertension, kidney and asthma, etc.),
lack of psychiatric background,
, minimum age of participant It will be 20 years and maximum 34 years.
.minimum diploma education
According to the Sleep Quality Questionnaire, a score above 5 according to the questionnaire indicates poor sleep quality</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>34 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>According to the participant and inability to continue,ed
pregnancy to high-risk pregnancy (risk of miscarriage and bleeding),
preterm labor (preterm delivery above 38 weeks),
acute stress during the course,
regular absence in training sessions,
and failure to attend The exercises will be at home.</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: In this study, a sample of 84 pregnant women in the second and third trimesters who refer to Sabzevar Health Centers was selected by available sampling method and randomly placed in two experimental and control groups (42 people each). . Upon completion of the pre-test, the 6-session intervention group will be trained in mindfulness exercises and will be given a questionnaire for sleep quality and dass21 questionnaires. And the interview will be conducted by a neuropsychiatrist. Individuals with a score above 5 in the sleep quality questionnaire have poor sleep quality (and, according to the 21dass questionnaire, their severity of moderate to severe depression are in the intervention group. The experimental group will be completed after the mindfulness interventions of the post-test questionnaires. First session: Automatic guidance (When we notice the automatic guidance, we find the presence of the mind) It can be busy; you go from job to job without having a chance to smell a beautiful flower. D or find out what's going on around you. In other words, it's your automatic guide that has control over you. A great way to regain control is to take time for meditation called "Mindfulness of Body and Soul." A simple eight-minute exercise designed to focus on the present. Second session: Focusing more on the body (focusing on the body reveals more mental whispers and leads to more control over the reaction to daily events). It is designed so that you can focus on your body. The body speaks very well. When he says he's hungry, it's almost impossible not to understand what he wants. However, they are a little more nuanced and easy to ignore, and the goal of a 14-minute "body scan" is to open the way for communication between your body and mind. It blows with every breath and with every exhale, it is empty. Pay attention to how you feel while doing this; For example, tingling in the legs or nausea. Remember that there is no winning or losing or failure. If he gets distracted, try to get him back to practice. Do this exercise twice a day for a week. Third session: By learning how the mind can often be busy and scattered, we learn to focus more consciously on breathing to provide more focus and integration. In the third session, it's time to take care of the "three-minute breath" that you have to do twice a day. At this point, take two minutes to focus on your emotions, thoughts, and body, then one minute for deep breathing, and focus on the inhale and exhale. Fourth session: Most often, when the mind wants to focus on something and avoid other things. It is wasted. In the mind-to-face approach to being present at the same time, one must look at events from a different angle in order to have a broad and different view of them. In this session, you should learn how to distance yourself from your thoughts. The meditation you are about to do is called "sounds and thoughts" or "sounds and thoughts": you do nothing for eighty minutes and you only pay attention to the sounds around you. When you realize that sounds come and go like tides, know that you've done the exercise right. When you are fully focused, your mind begins to tell a story based on the sounds you hear; For example, from a loud noise, it is thought that a cement brick has fallen from the roof. This meditation is a great way to learn how your mind works. At the end of the week, you will be much more comfortable with the flow and nature of your thoughts. Or try to change it for what it is. The exercise you do every day for ten minutes a week is called "Searching for Difficulties." Whenever you are ready, turn your thoughts to a difficult or unpleasant subject. Whatever it is; From your childhood illness to your child's poor grades in school. Try to figure out where you feel the thought in your body as soon as you find that point, while taking deep breaths, let those feelings be absorbed. This is the moment of acceptance and compassion that prepares you to be free and comfortable. Combine this meditation with previously learned meditations: "Body and Soul," "Sounds and Thoughts," "Searching for Difficulties," and "Three-Minute Breathing." Understanding that thoughts are just thoughts is reasonable, even for someone who doesn't believe it. This session is about a very general reason, which is another aspect of how to do it. A very general memory is a tendency to recall events from the past in a completely negative way. For example, you may feel awful throughout your high school years, when you really only have an unpleasant class. When you feel this way, you are easily blaming yourself and others. But blaming doesn't help reconcile with the past. In fact, research has shown that it makes it even more difficult.</i_keyword>
      <i_keyword>Control group:  People will be given a sleep quality questionnaire and dass21. And the interview will be conducted by a neuropsychiatrist. People who do not have a problem with sleep quality according to the sleep quality questionnaire (and do not suffer from depression according to the 21dass questionnaire) are in the control group and routine pregnancy care is done for the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sleep quality (pregnancy is an event that changes many aspects of a woman's life. It affects a woman's health and social roles and sometimes causes psychological problems in them. One of the problems during pregnancy is sleep disorders and a large percentage Pregnant women (especially in the third trimester of pregnancy) suffer from a change in the normal pattern of sleep and its disturbances, due to the fact that sleep disorders can cause many complications before, during and after childbirth. Timepoint: two months. Method of measurement: Filling the Pittsburgh Sleep Quality Questionnaire (PSQI) and training during mindfulness sessions for mothers.</prim_outcome>
      <prim_outcome>Depression includes mood swings, lack of self-confidence, hopelessness, lack of value in life, lack of interest in conflict, lack of enjoyment of life, and lack of energy and power. Timepoint: two months. Method of measurement: Depression, Anxiety and Stress Questionnaire (DASS-21).</prim_outcome>
      <prim_outcome>Anxiety includes things like physiological hyperactivity, fears, and situational anxiety. Timepoint: two months. Method of measurement: Depression, Anxiety and Stress Questionnaire (DASS-21).</prim_outcome>
      <prim_outcome>Two months. Timepoint: two months. Method of measurement: Depression, Anxiety and Stress Questionnaire (DASS-21).</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-08-13</approval_date>
        <contact_name>Mashhad Medical Sciences Ethics Committee</contact_name>
        <contact_address>Mashhad University of Medical Sciences sabzavar Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
