<?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>IRCT20210626051707N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-12-01</date_registration>
      <primary_sponsor>Khoram-Abad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of emotion release technique on sleep quality and mental health of the elderly</public_title>
      <acronym></acronym>
      <scientific_title>The effect of emotion release technique on sleep quality and mental health of the elderly</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-11-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59793</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: According to the inclusion and exclusion criteria, people enter the study. In order to equalize the distribution of two important confounders of age and sex, classes based on these two variables are described as "age group 60 to 65 years / age group 65 to 70 years / age group 70 to 75 years / age group 75 to 80 years" and The "male / female class" is created and then randomly divided into two groups of treatment and control in a balanced way (Block Randomization)The size of each block is 4 items, so that 6 different combinations of 4 blocks are created and are selected randomly by placing the blocks. Using this method, the sample size in the two study arms will be equal (balance) and the difference between the two groups in terms of sample size will be equal to a maximum of half a block (two people).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Elderly.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this clinical trial, after obtaining the approval of the ethics committee and the necessary permits from the Vice Chancellor for Research and Technology of Lorestan University of Medical Sciences, the intervention will begin and samples will be collected. Then, with informed consent, seniors with inclusion criteria will complete demographic information questionnaires, the Pittsburgh Sleep Quality Scale, and the Short Cognitive Status Scale.Sampling method in this study is a multi-stage method including cluster and random. They are randomly selected from the list of names of these centers.It should be noted that the list of elderly people with files in health centers after receiving administrative and legal steps, will be received from each center and samples will be selected from people over 60 years. After evaluating the elderly, samples based on inclusion criteria and Exits are selected. The intervention group performs EFT technique for 6 days, twice a day for 20 minutes each time.This technique is taught to the elderly in person so that the person can do it himself. This technique will be taught individually to the elderly. EFT follow-up will be done daily by telephone. Intervention 2: Control group: The control group does not receive any intervention. After performing the research steps, this group is trained in EFT. The samples of the control group do not receive any intervention and after the intervention, the EFT technique, if desired, These people will be trained. The EFT technique will be performed according to the EFT guide.</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 I have not decided yet and I do not have a plan</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Habib Zaheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khorramabad, Enghelab St., Arasteh Alley, No. 3, No. 97</address>
        <city>KHORRAM ABAD</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6816847175</zip>
        <telephone>+98 916 567 9150</telephone>
        <email>habibzaheri4060@gmail.com</email>
        <affiliation>Khoram-Abad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Afsaneh Beiranvand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>km 5 Road of Khorram Abad - Boroujerd - Opposite to the Kahrizak Village- Integrated Lorestan Medica</address>
        <city>KHORRAM ABAD</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6814993165</zip>
        <telephone>+98 66 3312 0139</telephone>
        <email>a_beiranvand2006@yahoo.com</email>
        <affiliation>Khoram-Abad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 60-70 years
Insomnia based on sleep quality questionnaire score (score above 5 Pittsburgh scales)
Dont have a serious physical and mental illness
Dont have a cognitive deficits (score less than 7 on the Cognitive Status Questionnaire (AMT) Abbreviated mental test
Dont have a drug addiction
Dont have a wounds in the areas of energy channels</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Lack of cooperation during the intervention
Use of benzodiazepines and other sedatives and hypnotics during the study
getting  severe physical and mental illness during the study
Occurrence of unfortunate events such as mourning and loss of elderly loved ones during research</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: In this clinical trial, after obtaining the approval of the ethics committee and the necessary permits from the Vice Chancellor for Research and Technology of Lorestan University of Medical Sciences, the intervention will begin and samples will be collected. Then, with informed consent, seniors with inclusion criteria will complete demographic information questionnaires, the Pittsburgh Sleep Quality Scale, and the Short Cognitive Status Scale.Sampling method in this study is a multi-stage method including cluster and random. They are randomly selected from the list of names of these centers.It should be noted that the list of elderly people with files in health centers after receiving administrative and legal steps, will be received from each center and samples will be selected from people over 60 years. After evaluating the elderly, samples based on inclusion criteria and Exits are selected. The intervention group performs EFT technique for 6 days, twice a day for 20 minutes each time.This technique is taught to the elderly in person so that the person can do it himself. This technique will be taught individually to the elderly. EFT follow-up will be done daily by telephone.</i_keyword>
      <i_keyword>Control group: The control group does not receive any intervention. After performing the research steps, this group is trained in EFT. The samples of the control group do not receive any intervention and after the intervention, the EFT technique, if desired, These people will be trained. The EFT technique will be performed according to the EFT guide</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sleep quality. Timepoint: Assessment of sleep quality scores before the intervention will be on the last day of the intervention and one month after the intervention. Method of measurement: Based on the Pittsburgh Standard Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Mental health. Timepoint: Before the intervention, it will be on the last day of the intervention and one month after the intervention. Method of measurement: Based on the DASS standard questionnaire.</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>Khoram-Abad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-03-12</approval_date>
        <contact_name>Lorestan Medical Sciences Ethics Committee</contact_name>
        <contact_address>Lorestan, Khorramabad, Lorestan University of Medical Sciences, Campus Kamalvand, Vice Chancellor for Research and Technology Khorram Abad Lorestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
