<?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>IRCT20190826044616N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-10-01</date_registration>
      <primary_sponsor>University of social welfare and rehabilitation sciences</primary_sponsor>
      <public_title>Effect of spaced retrieval training in Alzheimer`s disease</public_title>
      <acronym></acronym>
      <scientific_title>The effect of ٍeducational intervention by spaced retrieval method on pain perception in elderly with Alzheimer's disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>46</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/41725</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive, Randomization description: In this study, block randomization was used to ensure equilibrium of participants in two groups (mild Alzheimer's block or moderate Alzheimer's block). For this purpose, four-membered blocks consisting of all four possible combinations were defined as having two A members  (intervention group) and two B members  (control group), and at the time of randomization, a block was randomly selected and the samples assigned to the intervention or control group based on the results. The six possible four combinations are: 
AABB, ABAB, ABBA, BAAB, BABA, BBAA
One envelope was provided for each block, containing four cards, two cards marked A and two cards B. The order of the cards in each envelope was in accordance with one of the above  patterns and we had a total of six envelopes (numbered from one to six). At the time of random allocation, one of the envelopes was randomly selected, and as a result, four patients entered the study and their assignment was identified. when the envelope was identified, all four cards were not pulled out together, but with each patient, one card (in the envelope, respectively) was removed and discarded. After inserting four samples into two groups, the cards were placed in the same order at the envelope, and the envelope was returned to its original location.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Alzheimer's disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this study, educational intervention with spaced retrieval - errorless method was used. The target information provided to the elderly at the beginning of each session consisted of 16 images, of which 8 were images of painful situations, 5 were images of non-painful situations, and 3 were unrelated. These images were randomly selected from 128 images validated in previous studies. All images were related to familiar daily activities, and the photograph was taken in such a way that the situation was recognizable at first glance. Different types of mechanical, thermal and pressure pain have been depicted and these images are of different age and gender. These images have been used in similar studies to assess pain semantic memory. The elderly were asked to remember the target information. Then, at 45, 90, 180, 360, 720 seconds intervals, the elderly were asked to identify images of painful situations. The retrieval time was increased, if of the responses were correct. Every time the elderly failed to identify the images correctly, the time interval was reduced to a previous step, and the painful images were trained again. The images presented at each session were different from the previous session, and at the end, the elderly participants were introduced to 64 painful situations. Activities that do not require much memory function such as solving puzzles were used during data retrieval. Intervention 2: Control group: Eight free group discussion sessions were held twice a week.Meetings were held with easy, comprehensible, and interesting topics. The sessions lasted up to one hour.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Marjan Haghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Koodakyar ave., daneshjoo Bolv., Velenjak</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۹۸۵۷۱۳۸۷۱</zip>
        <telephone>+98 21 8825 6336</telephone>
        <email>ma.haghi@uswr.ac.ir</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Marjan Haghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Koodakyar ave., daneshjoo Bolv., Velenjak</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۹۸۵۷۱۳۸۷۱</zip>
        <telephone>+98 21 8825 6336</telephone>
        <email>ma.haghi@uswr.ac.ir</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>60 years and older
Mild and Moderate Alzheimer`s Disease
Spoken in Farsi
Signed written consent by patient or legal guardian</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unrecognized sensory deficits include blindness and hearing loss and aphasia
Drug abuse
History of diabetes because of the possibility of neuropathy
Stroke history due to the possibility of paralysis and paresis
Psychiatric illnesses such as schizophrenia and bipolar disorder
GDS-15 ≥8
CDR=3
Begin taking any pain medication during the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G30</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Alzheimer's disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In this study, educational intervention with spaced retrieval - errorless method was used. The target information provided to the elderly at the beginning of each session consisted of 16 images, of which 8 were images of painful situations, 5 were images of non-painful situations, and 3 were unrelated. These images were randomly selected from 128 images validated in previous studies. All images were related to familiar daily activities, and the photograph was taken in such a way that the situation was recognizable at first glance. Different types of mechanical, thermal and pressure pain have been depicted and these images are of different age and gender. These images have been used in similar studies to assess pain semantic memory. The elderly were asked to remember the target information. Then, at 45, 90, 180, 360, 720 seconds intervals, the elderly were asked to identify images of painful situations. The retrieval time was increased, if of the responses were correct. Every time the elderly failed to identify the images correctly, the time interval was reduced to a previous step, and the painful images were trained again. The images presented at each session were different from the previous session, and at the end, the elderly participants were introduced to 64 painful situations. Activities that do not require much memory function such as solving puzzles were used during data retrieval.</i_keyword>
      <i_keyword>Control group: Eight free group discussion sessions were held twice a week.Meetings were held with easy, comprehensible, and interesting topics. The sessions lasted up to one hour.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain severity questionnaire score. Timepoint: Measurement of pain intensity before and after 8 sessions of intervention. Method of measurement: Pain Assessment checklist for Seniors with Limited Ability to Communicate.</prim_outcome>
      <prim_outcome>The intensity of the electrical current that causes the pain (Pain Threshold). Timepoint: Measurement of pain intensity before and after 8 sessions of intervention. Method of measurement: Stimulator device amplitude.</prim_outcome>
      <prim_outcome>The number of  painful situation images that are correctly identified (Pain semantic memory). Timepoint: Measurement of pain intensity before and after 8 sessions of intervention. Method of measurement: Valid images of painful situations.</prim_outcome>
      <prim_outcome>The number of animals / fruits that the elderly can name in 60 seconds (semantic memory). Timepoint: Measurement of pain intensity before and after 8 sessions of intervention. Method of measurement: Verbal Fluency test.</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>University of social welfare and rehabilitation sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-02-08</approval_date>
        <contact_name>Ethics committee of University of Social Welfare and Rehabilitation Sciences</contact_name>
        <contact_address>Koodakyar Ave., Daneshjoo Blvd., Velenjak Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
