<?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>IRCT20180923041101N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-04-16</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Emotional Freedom Technique (EFT) on Sleep Quality and Anxiety of Elderly</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Emotional Freedom Technique (EFT) on Sleep Quality and Anxiety of Elderly</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-04-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/51483</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: After selection of participants based on the inclusion criteria, the random allocation method in this study will be the permutation block method, where A represents the person receiving the intervention and B represents the person who does not receive the intervention. This method is performed by considering 4 blocks so that the total number of 4 permutations is equal to 6.
Then, using a table of random numbers and assigning code zero to 9 to each of the permutations (ABAB code 0, BABA code 1, AABB code 2, BBAA code 3, BAAB code 4 and ABBA code 5 to 9), a random list of 60 The desired consisting of 20 blocks of 4 (4 * 20 = 80 total number of samples) is generated and the order of assignment to each of the samples participating in the study is determined. How to use the table of random numbers is that the starting point is selected randomly and 20 numbers from zero to 9 are selected randomly (row or column) and the permutation assigned to each number is noted. (The order of placement of shifts next to each other will be from left to right) and how to allocate a total of 80 people to two groups A and B will be determined. (40 people in each group). These steps are performed using random allocation software, Blinding description: In this study,  the evaluator of outcome are kept blind to the type of intervention. In this way, the outcome evaluator fills the questionnaire in the appointed time (day 1 and final day after 8 week), and does not know the allocation of the groups.</study_design>
      <phase>3</phase>
      <hc_freetext>Sleep quality, Anxiety.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention sessions are performed in 8 sessions (twice a week for four weeks) in the morning for 15 minutes while the elderly person is sitting on a chair. The technique is that at the beginning of each session, participants are asked to rate their level of mental distress on a scale of 1 to 10, with 1 indicating the lowest and 10 the highest level of distress. The statement confirming the acceptance of this mental disorder is repeated 3 times. For example, "Even if I have this problem, I accept myself deeply and completely", this phrase is different for each person. Sequence of striking points, first the point of the karate stick and then the meridian point (head difference), between the eyebrows, both sides of the eyes, under the eyes, under the nose, under the lips, two claws in the chest, under the arms (below the armpit) The index finger, thumb, middle finger, and little finger are taught, and participants are asked to repeat the affirmative phrase when tapping the point of the meridian and the karate stick. And then point 9 - Gammot and turning the eyes to communicate with the two hemispheres of the brain along with whispering favorite music is taught. These steps will be repeated during 8 sessions. Intervention 2: Control group: A group on which no intervention will be made.</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:
Analyzed data can be shared after completion of the study as an article.

When:
Start of access period 6 months after publication of results.

To whom:
All of the researchers in Medical Sciences Universities.

Conditions:
Analysis of data based on statistical software.

Where to obtain:
Dr. Majid Najafi Kalyani

How to obtain:
Sending request, permission from Ethic Committee, sending data.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Shakibavand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zand St</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>13119–71936</zip>
        <telephone>+98 71 3647 4254</telephone>
        <email>nadia1374.ns@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Majid Najafi Kalyani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Namazee St</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3119–171936</zip>
        <telephone>+98 71 3647 4251</telephone>
        <email>najafikalyani@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 60 years and older
Absence of mental illness or use of psychiatric and psychiatric drugs
Patients with sleep and anxiety disorders according to the Sleep and Anxiety Quality Assessment Questionnaire
Absence of cognitive and motor disorders</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pain before the intervention due to illnesses that prevents the intervention
Lack of literacy to complete the questionnaires and understand the process of work</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>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention sessions are performed in 8 sessions (twice a week for four weeks) in the morning for 15 minutes while the elderly person is sitting on a chair. The technique is that at the beginning of each session, participants are asked to rate their level of mental distress on a scale of 1 to 10, with 1 indicating the lowest and 10 the highest level of distress. The statement confirming the acceptance of this mental disorder is repeated 3 times. For example, "Even if I have this problem, I accept myself deeply and completely", this phrase is different for each person. Sequence of striking points, first the point of the karate stick and then the meridian point (head difference), between the eyebrows, both sides of the eyes, under the eyes, under the nose, under the lips, two claws in the chest, under the arms (below the armpit) The index finger, thumb, middle finger, and little finger are taught, and participants are asked to repeat the affirmative phrase when tapping the point of the meridian and the karate stick. And then point 9 - Gammot and turning the eyes to communicate with the two hemispheres of the brain along with whispering favorite music is taught. These steps will be repeated during 8 sessions.</i_keyword>
      <i_keyword>Control group: A group on which no intervention will be made.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sleep Quality. Timepoint: Day 1 and 35. Method of measurement: Pittsburg Inventory.</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: Day 1 and 35. Method of measurement: Speilberger's Anxiety 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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-05-05</approval_date>
        <contact_name>Research Ethics Committee Shiraz University of Medical Sciences</contact_name>
        <contact_address>Zand St Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
