<?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>IRCT20220529055015N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-01-24</date_registration>
      <primary_sponsor>Yasouj University of Medical Sciences</primary_sponsor>
      <public_title>Efficacy of eye Movements Desensitization and Reprocessing on the Psychological Well-being</public_title>
      <acronym></acronym>
      <scientific_title>Efficacy of eye Movements Desensitization and Reprocessing on the Psychological Well-being of the Patients with chronic renal failure under Hemodialysis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-01-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63963</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The  samples were divided into two groups through a random block allocation process. In order to create the sequence and concealment, the online software with the following address will be used, and a special randomization code will be generated.
Sealed Envelope Ltd. 2021. Create a blocked randomisation list. [Online] Available from: https://www.sealedenvelope.com/simple-randomiser/v1/lists [Accessed 18 Jun 2022
To perform this method, the number of intervention groups (two groups A and B), the size of each block (blocks of 6) and the number of sample size (90 samples) were entered in the mentioned site. Then the site presented a list with 15 blocks of 6. In this study, we use blocks of 6, and the website performs randomization and assigns numbers to the blocks.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Psychological well-being.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The study will be done in both morning and evening shifts at Hajieh Narges Mahshahr Hospital.  Then, for the intervention group, the researcher will perform EMDR treatment three times a week for 4 weeks in a row in 30-45 minutes sessions after hemodialysis in a room previously coordinated with the hospital authorities. After the intervention, psychological well-being components will be measured again in this group. The method of desensitization with eye movements and reprocessing consists of 8 steps: First step: the traumatic scene or scenes will be identified with the cooperation of the patient and the researcher. Then, with the cooperation of the patient, the most uncomfortable traumatic scene is selected. The second stage (explanation and preparation): creating a therapeutic alliance, explaining the process of desensitization with eye movements and reprocessing, explaining the effects of the desensitization method with eye movements and reprocessing, explaining treatment expectations and preparing clients. The third stage (examination): In this stage, the client is asked to visualize the scene or incident that creates the most positive and peaceful feeling in his mind. The fourth stage (desensitization of the target): focusing on the negative belief. The client moves the therapist's fingers quickly and simultaneously to the left and right in front of him, asking the client to follow the movements of the fingers with only eye movements. The fifth stage (creating positive cognition): cognitive reconstruction, strengthening the client's positive belief to replace the negative belief. The sixth stage (body processing): asking the helper to join and maintain the target event at the same time and recognizing the positive word and checking the muscle tension. The seventh stage (ending the sessions): asking the client to express the disturbing image, thoughts or emotions experienced. During the treatment, remember the events experienced in the treatment process in the form of thoughts, conditions, dreams, memories and other issues in the notebook. The eighth stage (re-evaluation): evaluation of previously processed goals (evaluation of the main variable). Visual tracking of the movement of the therapist's finger in the same state that the patient imagines the traumatic scene one after another - the patient must follow the rapid movements of the therapist's finger, which is across his field of vision, with rapid eye movements. The therapist's finger should be approximately 30 cm away from the subject's eyes and move from right to left and vice versa in the patient's field of vision. This movement consists of going back and forth twice in one second, which is considered one cycle, and every 12-24 cycles is one set. After each set, the therapist tells the patient to stop visualizing the scene and lean back in his chair and take a deep breath. This process is repeated several times according to the needs and motivation level of the patient. Intervention 2: Control group: In the control group, there will be no intervention other than routine medical care and support of these people by their families. Routine interventions include nursing care before, during and after hemodialysis, which can also include nursing consultations. Continuing to use medications prescribed by doctors.</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 After holding a meeting with other members of the research team and the ethics committee of the organization, the final decision will be announced</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Behnammoghadam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Motahari Blvd.- Yasouj University of Medical Sciences, Yasouj</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7591994799</zip>
        <telephone>+98 74 3333 7230</telephone>
        <email>mbehnam1363@gmail.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Behnammoghadam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Motahari Blvd.- Yasouj University of Medical Sciences, Yasouj</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7591994799</zip>
        <telephone>+98 74 3333 7230</telephone>
        <email>mbehnam1363@gmail.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>having consent  informed to enter the study
Patients who undergo regular hemodialysis three times a week.
Has a history of hemodialysis treatment for more than three months
Age between 15 and 60 years</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having  history of seizures
Having mental illnesses
Having addictions
Having vision problems</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>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The study will be done in both morning and evening shifts at Hajieh Narges Mahshahr Hospital.  Then, for the intervention group, the researcher will perform EMDR treatment three times a week for 4 weeks in a row in 30-45 minutes sessions after hemodialysis in a room previously coordinated with the hospital authorities. After the intervention, psychological well-being components will be measured again in this group. The method of desensitization with eye movements and reprocessing consists of 8 steps: First step: the traumatic scene or scenes will be identified with the cooperation of the patient and the researcher. Then, with the cooperation of the patient, the most uncomfortable traumatic scene is selected. The second stage (explanation and preparation): creating a therapeutic alliance, explaining the process of desensitization with eye movements and reprocessing, explaining the effects of the desensitization method with eye movements and reprocessing, explaining treatment expectations and preparing clients. The third stage (examination): In this stage, the client is asked to visualize the scene or incident that creates the most positive and peaceful feeling in his mind. The fourth stage (desensitization of the target): focusing on the negative belief. The client moves the therapist's fingers quickly and simultaneously to the left and right in front of him, asking the client to follow the movements of the fingers with only eye movements. The fifth stage (creating positive cognition): cognitive reconstruction, strengthening the client's positive belief to replace the negative belief. The sixth stage (body processing): asking the helper to join and maintain the target event at the same time and recognizing the positive word and checking the muscle tension. The seventh stage (ending the sessions): asking the client to express the disturbing image, thoughts or emotions experienced. During the treatment, remember the events experienced in the treatment process in the form of thoughts, conditions, dreams, memories and other issues in the notebook. The eighth stage (re-evaluation): evaluation of previously processed goals (evaluation of the main variable). Visual tracking of the movement of the therapist's finger in the same state that the patient imagines the traumatic scene one after another - the patient must follow the rapid movements of the therapist's finger, which is across his field of vision, with rapid eye movements. The therapist's finger should be approximately 30 cm away from the subject's eyes and move from right to left and vice versa in the patient's field of vision. This movement consists of going back and forth twice in one second, which is considered one cycle, and every 12-24 cycles is one set. After each set, the therapist tells the patient to stop visualizing the scene and lean back in his chair and take a deep breath. This process is repeated several times according to the needs and motivation level of the patient.</i_keyword>
      <i_keyword>Control group: In the control group, there will be no intervention other than routine medical care and support of these people by their families. Routine interventions include nursing care before, during and after hemodialysis, which can also include nursing consultations. Continuing to use medications prescribed by doctors.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Psychological well-being. Timepoint: Before the intervention and immediately after the intervention. Method of measurement: Psychological well-being 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>Yasouj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-03-14</approval_date>
        <contact_name>Yasouj University of Medical Sciences</contact_name>
        <contact_address>Shahid Motahari Blvd.- Yasouj University of Medical Sciences-Yasouj Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
