<?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>IRCT20150519022320N25</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-02-22</date_registration>
      <primary_sponsor>Rafsanjan University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of music therapy and laughter yoga on depression in the elderly</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of two methods of music therapy and laughter yoga on depression in the elderly</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-02-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61822</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: After identifying the depressed elderly according to the inclusion criteria and its listing, they will be divided into 3 groups of 30 people A, B and C by simple random division using a table of random numbers and then the groups will be divided again by simple random division. On each group (2 intervention groups and one control group) it will be determined what intervention will be done on each group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Depression in the elderly.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The music intervention group will undergo music therapy for 8 weeks and 2 sessions per week for 30 minutes. The type of music to be intervened is a piece prepared with soothing songs with a gentle, happy and relaxing style, and preferably first the priority will be chosen by the taste of the elderly, and finally the final music file will be approved by the tutor and the consultant. This intervention will be done at home and preferably with headphones on pre-determined and agreed days by the researcher and the elderly for 30 minutes to the songs that are uploaded to the WhatsApp group and how to follow it. They were asked to notify the researcher immediately after listening to the music on the pre-arranged day. Intervention 2: Intervention group: The Laughter Yoga intervention group will also undergo Laughter Yoga intervention for 8 weeks and 2 sessions per week. The laughter yoga intervention group is divided into two groups, men and women, and as a group, the intervention in the gym will be pre-determined and will be performed on the elderly group at a time determined and predetermined by the researcher. During these 8 weeks of intervention, if the corona peak starts again and interrupts the intervention, this intervention will be followed virtually and a training video on how to perform Laughter Yoga in WhatsApp will be sent to them and in WhatsApp the absence of direction. Ensure the implementation of the intervention will be done. Intervention 3: Control group: The control group will be formed by the WhatsApp group for 8 weeks by the researcher, and the problems that will arise in the aging process will be explained aloud, and their medical questions and problems will be answered.</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 No further information available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr.Tayebeh Mirzaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing, Nurse blvd., Jomhury street, Rafsanjan</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7718174715</zip>
        <telephone>+98 34 3428 0038</telephone>
        <email>t.mirzaei@rums.ac.ir</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Tayebe Mirzaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing, Nurse blvd., Jomhury street, Rafsanjan</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7718174715</zip>
        <telephone>+98 34 3428 0038</telephone>
        <email>T.Mirzaei@rums.ac.ir</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being over 60 years old
Lack of severe hearing problems
Ability to use a smartphone
Obtaining a score higher than 6 from the GDS questionnaire
No addiction and use of psychiatric drugs
Not having severe physical and mental problems
Do not suffer from cognitive disorders based on medical diagnosis and being treated
No psychological problems in the last 6 months</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Reluctance to continue cooperation
Start taking antidepressants
Performing exercises and other interventions that affect depression
Do not do more than 3 sessions of exercises</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Depression</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The music intervention group will undergo music therapy for 8 weeks and 2 sessions per week for 30 minutes. The type of music to be intervened is a piece prepared with soothing songs with a gentle, happy and relaxing style, and preferably first the priority will be chosen by the taste of the elderly, and finally the final music file will be approved by the tutor and the consultant. This intervention will be done at home and preferably with headphones on pre-determined and agreed days by the researcher and the elderly for 30 minutes to the songs that are uploaded to the WhatsApp group and how to follow it. They were asked to notify the researcher immediately after listening to the music on the pre-arranged day.</i_keyword>
      <i_keyword>Intervention group: The Laughter Yoga intervention group will also undergo Laughter Yoga intervention for 8 weeks and 2 sessions per week. The laughter yoga intervention group is divided into two groups, men and women, and as a group, the intervention in the gym will be pre-determined and will be performed on the elderly group at a time determined and predetermined by the researcher. During these 8 weeks of intervention, if the corona peak starts again and interrupts the intervention, this intervention will be followed virtually and a training video on how to perform Laughter Yoga in WhatsApp will be sent to them and in WhatsApp the absence of direction. Ensure the implementation of the intervention will be done.</i_keyword>
      <i_keyword>Control group: The control group will be formed by the WhatsApp group for 8 weeks by the researcher, and the problems that will arise in the aging process will be explained aloud, and their medical questions and problems will be answered.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>GDS Questionnaire Depression Score. Timepoint: Before, immediately and one month after the intervention. Method of measurement: Geriatric Depression Scale.</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>Rafsanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-02-06</approval_date>
        <contact_name>Research Ethics Committee of Rafsanjan University of Medical Sciences</contact_name>
        <contact_address>School of Nursing and Midwifery, Nurse Avenue, Rafsanjan Rafsanjan Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
