<?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>IRCT2016122031489N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-11-19</date_registration>
      <primary_sponsor>Deputy of Research and Technology of Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of palliative care nursing (Namaste) on elderly patients with dementia</public_title>
      <acronym></acronym>
      <scientific_title>The effect of palliative care (Namaste) on quality of life, pain, anxiety in elderly patients with dementia living in Nursing homes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-05-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>25</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/24766</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Alzheimer.</hc_freetext>
      <i_freetext>The Namaste Care intervention is guided by concepts of person-centered care and maintaining a sense of ‘personhood’ within a palliative approach to dementia care. It was designed for those with dementia, and uses a high sensory and touch approach. Namaste Care provides an alternative to task-oriented care by creating meaningful activities, gentle touch for those ‘silent’ residents who are nearing death, often neglected and ‘stuck in their rooms . It runs 5 days/week 2 hours/day. In our study, we will use dedicated rooms for Namaste Care that are quiet and within a high sensory yet calming environment. Family involvement will be encouraged; they can participate in any activities that they prefer. (e.g., applying hand cream, brushing hair, assisting with nourishments). In the Namaste room, lighting is subdued, soothing music is played and the scent of lavender permeates the room.  Residents are positioned in a comfortable reclining chair. In Namaste Care, food and liquids are offered by Carers, family members, or volunteers as both a pleasurable activity and a way to keep residents nourished and hydrated. About 20 minutes before lunch, the residents need to be stimulated to prepare for leaving the room and having a meal.  The lights are turned up, music is livelier and items that reflect the weather, season or holiday will be shown to them..</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Amrollah Majdabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nosrat st, Tohid sq, Tehran, IRAN, Postal code: 141973317</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>Iran</zip>
        <telephone>+98 21 6105 4209</telephone>
        <email>afsaneha1358@gmail.com</email>
        <affiliation>School of Nursing &amp; Midwifery,Tehran University of Medical Sciences, Tehran, Iran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nasriv  Nikpeyma</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nosrat st, Tohid sq, Tehran, IRAN, Postal code: 141973317</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>Iran</zip>
        <telephone>+98 21 6105 4207</telephone>
        <email>nikpeyma@yahoo.com</email>
        <affiliation>School of Nursing &amp; Midwifery,Tehran University of Medical Sciences, Tehran, Iran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Suffering from Alzheimer's disease؛ to be able to talk and have the ability to participate in the study &#13;
&#13;
Exclusion criteria: Non-participation in meetings for 3 weeks (12 sessions)</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>70 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G30.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Alzheimer disease, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The Namaste Care intervention is guided by concepts of person-centered care and maintaining a sense of ‘personhood’ within a palliative approach to dementia care. It was designed for those with dementia, and uses a high sensory and touch approach. Namaste Care provides an alternative to task-oriented care by creating meaningful activities, gentle touch for those ‘silent’ residents who are nearing death, often neglected and ‘stuck in their rooms . It runs 5 days/week 2 hours/day. In our study, we will use dedicated rooms for Namaste Care that are quiet and within a high sensory yet calming environment. Family involvement will be encouraged; they can participate in any activities that they prefer. (e.g., applying hand cream, brushing hair, assisting with nourishments). In the Namaste room, lighting is subdued, soothing music is played and the scent of lavender permeates the room.  Residents are positioned in a comfortable reclining chair. In Namaste Care, food and liquids are offered by Carers, family members, or volunteers as both a pleasurable activity and a way to keep residents nourished and hydrated. About 20 minutes before lunch, the residents need to be stimulated to prepare for leaving the room and having a meal.  The lights are turned up, music is livelier and items that reflect the weather, season or holiday will be shown to them.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of Life. Timepoint: Before intervention and 6 months after intervention. Method of measurement: QUALITY OF LIFE IN LATE-STAGE DEMENTIA (QUALID) SCALE.</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: Before intervention and 6 months after intervention. Method of measurement: questionnaire, Hamilton Anxiety Rating Scale (HAM-A).</prim_outcome>
      <prim_outcome>Pain. Timepoint: Before intervention and 6 months after intervention. Method of measurement: Pain Assessment Checklist for Seniors with Limited Ability to Communicate-II.</prim_outcome>
      <prim_outcome>Neuropsychological symptoms. Timepoint: Before intervention and 6 months after intervention. Method of measurement: Neuropsychiatric Inventory – Nursing Home.</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>Deputy of Research and Technology of Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-11-15</approval_date>
        <contact_name>Ethics Committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Eastern Nusrat Street, Tawhid Square, Postal Code: 1419733171 Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
