<?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>IRCT20240917063074N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-10-22</date_registration>
      <primary_sponsor>Qazvin University of Medical Sciences</primary_sponsor>
      <public_title>Examining the Impact of Mindfulness Intervention on Treatment Adherence in       Hemodialysis Patients</public_title>
      <acronym></acronym>
      <scientific_title>Examining the Impact of Mindfulness Intervention on Treatment Adherence in       Hemodialysis Patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-10-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/79187</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: The samples will be allocated to intervention and control groups using random allocation software 1.0.0. In this way, the sequence of samples will be determined by the software, which consists of 12 blocks of 6. In order to hide the random allocation process, the names of the groups will be placed in envelopes and numbered from 1 to 120 and arranged in a box. After entering the study, the samples are placed in one of the intervention and control groups according to the content of the envelope.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: The effect of mindfulness intervention in hemodialysis patients. Condition 2: Adherence to treatment in hemodialysis patients.</hc_freetext>
      <i_freetext>Intervention 1: "Intervention group": First session 1- Introducing mindfulness training and its definition and explaining the reason for implementing this training course for the participants, explaining how to plan for mindfulness exercises and include these exercises in daily life, daily notes about mindfulness exercises, Training and performing exercises related to the postures of mindfulness meditation exercises (sitting on a chair, lying down, sitting on all fours, full lotus position, hands position) 2- performing attention to breathing exercises; This exercise involves paying attention to breathing and the participants should not try to control their breathing. Mindful breathing means being aware of each inhale and exhale. The second session 1- repeating the exercise of paying attention to breathing 2- doing the exercise of body scan; This exercise takes about 45 minutes and is one of the official mindfulness exercises. In this exercise, the participants lie down and pay attention to each part of the body in a specific order. In addition to paying attention to the present moment, this exercise increases the concentration and flexibility of attention. 3- Teaching physical examination exercise and meditation on all days of the week for 30 minutes, exercise review, homework review, third session 1- Doing meditation in the state sitting In this meditation, it is better to keep the spine completely straight so that the alertness is at the maximum level. In this meditation, attention is paid to breathing, paying attention to each inhalation and exhalation and following it moment by moment. This exercise takes about 30 minutes. 2- The exercise of attention to breathing includes several options: sitting with breathing, sitting with breathing and A whole title - practice of sitting with sounds (in this practice listening to sounds without judging them is desired) - practice of sitting with thoughts and feelings (observing thoughts and feelings as they are) 3 - Reviewing homework and reviewing walking and eating with presence mind, explanations about breathing and three-minute breathing concentration practice, homework (practice pleasant thoughts and feelings and disturbing thoughts and recording pleasant and unpleasant events every day) characteristics of optimistic and pessimistic people Fourth session 1- Doing conscious mind movements (yoga) that It increases balance and flexibility. Mindful hatha yoga is one of the formal exercises of mindfulness, which includes slow stretching movements with moment-to-moment attention to breathing and body sensations that are created during the exercise. 2- Seeing and hearing meditation training, 6-minute exercise Seeing or hearing, 40 minutes of meditation (awareness of breathing, body, voice and thoughts, awareness of problems and how they are exacerbated by thoughts and paying attention to how we react to thoughts and emotions or physical sensations with We communicate our experiences and express the difficulties that arise during exercise and pay attention to their effects on the body and the reaction to them) review of physical examination exercise, homework, definition of self-efficacy and people with this characteristic. Fifth session 1 - Carrying out the exercise of mindfully eating raisins with the aim of increasing awareness of the present moment and getting out of the state of automatic guidance 2- Reviewing the 3-minute breathing exercise with the presence of the mind, reviewing the meditation exercise of walking and doing activities with the presence of the mind, responding kindly to emotions Strong and fierce, homework, characteristics of people resistant to hardships. Sixth session 1- Doing mindful walking meditation (being aware of every moment while walking) 2- Sitting meditation for 40 minutes (awareness of breathing, body, sounds and then the practice of reviewing thoughts), reviewing the homework of the seventh session 1- Reviewing and repeating the exercises of the previous sessions and talking about the present moment 2- Explanation about the formal and informal exercises of mindfulness 3- Reviewing the 3-minute breathing, reviewing the exercises, reviewing Homework, practice observing the connection between activity and mood, setting limits and boundaries consciously, loving meditation, making a list of enjoyable physical activities and planning a suitable schedule for doing such activities, reminding when the session ends. Eighth 1- At this stage, according to the Kabat Zain program, the participants are given the opportunity to evaluate the exercises they have done so far and choose the exercises that they think are suitable for them. In fact, create your own personal mindfulness program. Whether they want to do formal or informal exercises, or whether they want to practice with or without audio guide files. In any case, this session is the last session of the eight-week mindfulness program and the first practice session of each person in his life. Continue practicing sitting meditation; In this meditation, it is better to keep the spine completely straight so that the alertness is at the maximum level. In this meditation, attention is paid to breathing, paying attention to each inhalation and exhalation and following it moment by moment. This exercise takes about 30 minutes. 2- The exercise of attention to breathing includes several options: sitting with breathing, sitting with breathing and A whole title - practice of sitting with sounds (in this practice listening to sounds without judging them is desired) - practice of sitting with thoughts and feelings (observing thoughts and feelings as they are) 3 - Reviewing homework and reviewing walking and eating with presence mind, explanations about breathing and three-minute breathing concentration practice, homework (practice pleasant thoughts and feelings and disturbing thoughts and record pleasant and unpleasant events every day) characteristics of optimistic and pessimistic people 1- Performing conscious mind movements (yoga) that Increases balance and flexibility. Mindful hatha yoga is one of the formal exercises of mindfulness, which includes slow stretching movements with moment-to-moment attention to breathing and body sensations that are created during the exercise. 2- Seeing and hearing meditation training. Intervention 2: "Control group": The control group does not receive any special training during the period when the intervention group receives mindfulness training, and according to the routine program, only hemodialysis is performed for this group. At the end of the intervention, educational pamphlets will be provided to 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
It can be shared after de-identifying people

When:
Since 1404

To whom:
Researchers working in academic and hospital institutions

Conditions:
For bedside use and treatment

Where to obtain:
Email address

How to obtain:
a week

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Mirzaei Jirandehi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 963، Milad 2 compelex، Noroozian Ave</address>
        <city>qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3414879957</zip>
        <telephone>+98 28 3367 4307</telephone>
        <email>mf589710@gmail.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Mirzaei jirandehi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Noroozian</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3414879957</zip>
        <telephone>+98 28 3367 4307</telephone>
        <email>mf589710@gmail.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having at least three months of dialysis experience
Sufficient literacy and the ability to use a smartphone and use virtual spaces
Failure to participate in other psychological programs</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Use of psychiatric drugs</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z99.2</hc_code>
      <hc_code>Z99.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Dependence on renal dialysis</hc_keyword>
      <hc_keyword>Dependence on renal dialysis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>"Intervention group": First session 1- Introducing mindfulness training and its definition and explaining the reason for implementing this training course for the participants, explaining how to plan for mindfulness exercises and include these exercises in daily life, daily notes about mindfulness exercises, Training and performing exercises related to the postures of mindfulness meditation exercises (sitting on a chair, lying down, sitting on all fours, full lotus position, hands position) 2- performing attention to breathing exercises; This exercise involves paying attention to breathing and the participants should not try to control their breathing. Mindful breathing means being aware of each inhale and exhale. The second session 1- repeating the exercise of paying attention to breathing 2- doing the exercise of body scan; This exercise takes about 45 minutes and is one of the official mindfulness exercises. In this exercise, the participants lie down and pay attention to each part of the body in a specific order. In addition to paying attention to the present moment, this exercise increases the concentration and flexibility of attention. 3- Teaching physical examination exercise and meditation on all days of the week for 30 minutes, exercise review, homework review, third session 1- Doing meditation in the state sitting In this meditation, it is better to keep the spine completely straight so that the alertness is at the maximum level. In this meditation, attention is paid to breathing, paying attention to each inhalation and exhalation and following it moment by moment. This exercise takes about 30 minutes. 2- The exercise of attention to breathing includes several options: sitting with breathing, sitting with breathing and A whole title - practice of sitting with sounds (in this practice listening to sounds without judging them is desired) - practice of sitting with thoughts and feelings (observing thoughts and feelings as they are) 3 - Reviewing homework and reviewing walking and eating with presence mind, explanations about breathing and three-minute breathing concentration practice, homework (practice pleasant thoughts and feelings and disturbing thoughts and recording pleasant and unpleasant events every day) characteristics of optimistic and pessimistic people Fourth session 1- Doing conscious mind movements (yoga) that It increases balance and flexibility. Mindful hatha yoga is one of the formal exercises of mindfulness, which includes slow stretching movements with moment-to-moment attention to breathing and body sensations that are created during the exercise. 2- Seeing and hearing meditation training, 6-minute exercise Seeing or hearing, 40 minutes of meditation (awareness of breathing, body, voice and thoughts, awareness of problems and how they are exacerbated by thoughts and paying attention to how we react to thoughts and emotions or physical sensations with We communicate our experiences and express the difficulties that arise during exercise and pay attention to their effects on the body and the reaction to them) review of physical examination exercise, homework, definition of self-efficacy and people with this characteristic. Fifth session 1 - Carrying out the exercise of mindfully eating raisins with the aim of increasing awareness of the present moment and getting out of the state of automatic guidance 2- Reviewing the 3-minute breathing exercise with the presence of the mind, reviewing the meditation exercise of walking and doing activities with the presence of the mind, responding kindly to emotions Strong and fierce, homework, characteristics of people resistant to hardships. Sixth session 1- Doing mindful walking meditation (being aware of every moment while walking) 2- Sitting meditation for 40 minutes (awareness of breathing, body, sounds and then the practice of reviewing thoughts), reviewing the homework of the seventh session 1- Reviewing and repeating the exercises of the previous sessions and talking about the present moment 2- Explanation about the formal and informal exercises of mindfulness 3- Reviewing the 3-minute breathing, reviewing the exercises, reviewing Homework, practice observing the connection between activity and mood, setting limits and boundaries consciously, loving meditation, making a list of enjoyable physical activities and planning a suitable schedule for doing such activities, reminding when the session ends. Eighth 1- At this stage, according to the Kabat Zain program, the participants are given the opportunity to evaluate the exercises they have done so far and choose the exercises that they think are suitable for them. In fact, create your own personal mindfulness program. Whether they want to do formal or informal exercises, or whether they want to practice with or without audio guide files. In any case, this session is the last session of the eight-week mindfulness program and the first practice session of each person in his life. Continue practicing sitting meditation; In this meditation, it is better to keep the spine completely straight so that the alertness is at the maximum level. In this meditation, attention is paid to breathing, paying attention to each inhalation and exhalation and following it moment by moment. This exercise takes about 30 minutes. 2- The exercise of attention to breathing includes several options: sitting with breathing, sitting with breathing and A whole title - practice of sitting with sounds (in this practice listening to sounds without judging them is desired) - practice of sitting with thoughts and feelings (observing thoughts and feelings as they are) 3 - Reviewing homework and reviewing walking and eating with presence mind, explanations about breathing and three-minute breathing concentration practice, homework (practice pleasant thoughts and feelings and disturbing thoughts and record pleasant and unpleasant events every day) characteristics of optimistic and pessimistic people 1- Performing conscious mind movements (yoga) that Increases balance and flexibility. Mindful hatha yoga is one of the formal exercises of mindfulness, which includes slow stretching movements with moment-to-moment attention to breathing and body sensations that are created during the exercise. 2- Seeing and hearing meditation training.</i_keyword>
      <i_keyword>"Control group": The control group does not receive any special training during the period when the intervention group receives mindfulness training, and according to the routine program, only hemodialysis is performed for this group. At the end of the intervention, educational pamphlets will be provided to the control group</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Determining compliance with treatment based on Kim's questionnaire. Timepoint: At the beginning of the study, immediately after the end of the intervention, one month later. Method of measurement: Questionnaire of adherence to the treatment of hemodialysis patients, Kim.</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>Qazvin University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-09-17</approval_date>
        <contact_name>Ethics Committee in Biomedical Research, Qazvin University of Medical Sciences</contact_name>
        <contact_address>No 963، Milad 2 complex، Noroziyan ave qazvin Qazvin Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
