<?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>IRCT20240122060767N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-01-29</date_registration>
      <primary_sponsor>Bojnourd University of Medical Sciences</primary_sponsor>
      <public_title>The effect of group art therapy on stress, depression, anxiety and loneliness of the elderly living in the nursing homes in North Khorasan Province in 2023</public_title>
      <acronym></acronym>
      <scientific_title>The effect of group art therapy on stress, depression, anxiety and loneliness of the elderly living in the nursing homes in North Khorasan Province in 2023</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-04-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/75169</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive, Randomization description: Sampling method In this research, available sampling is selected and random allocation of two control and test groups will be done by simple random method in the form of lottery.
After selecting the elderly who meet the entry criteria, each member of the sample was given a specified number, and then to determine the sample members by drawing lots in the presence of a witness, the numbers were put in a box and then the desired number was drawn by lottery. He removed the box containing the number of members who will enter the test group (25 people), then 25 people will be selected as the control group by lot.
After the pre-test, the samples that are in the low category in terms of anxiety or stress or depression will be removed and re-sampling will be done to reach the determined sample size.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Anxiety, stress, depression, loneliness, group art therapy, elderly.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this study, the intervention includes group art therapy. Group art therapy based on painting and music in this research includes 12 sessions (one month) that are held three days a week (Saturday, Monday, Wednesday or Sunday, Tuesday and Thursday), and each session lasts for one hour. It will be held in three parts: warm-up, program implementation and summation. The venue is a room in the care centers for the elderly. Each group will receive a total of twelve intervention sessions. Each art therapy session begins with a 10-minute warm-up. In these 10 minutes, the researcher warms up the members for that meeting by telling a story related to the topic of that meeting and introducing an activity related to the same meeting, and then 30 minutes to implement the special and predetermined program of that meeting and the last 20 minutes to The presentation of each person's artwork and the discussion between the group members are assigned. For each session, a predetermined program is developed, which includes painting with different techniques and with different materials and methods, such as making a tag for one's own name, preparing by using warm-up techniques such as scribble and finding images in between. Draw lines and color them, draw (draw a front view), draw a family member as an animal, draw (an animal he likes to be) as an art activity, draw his own and others' faces, draw a gift he likes to receive and give a gift to his family members, expressing one's thoughts by performing a practical task, creating a book of life with a drawing (various topics such as the first and most important memory he had from childhood to the present day or the most important event in his life or three wishes who likes to be fulfilled), finger painting by listening to three wordless music (first lively and then sad and finally relaxing), review of previous sessions and integration of achievements presented by the researcher. The last meeting includes summarizing and preparing people to finish the meetings. Intervention 2: Control group: Control group: For the control group, the normal daily program of nursing homes will be implemented and no art therapy intervention will be done. In order to respect the rights of the elderly and prevent any unpleasant feelings or discrimination, in addition to explaining the conditions of the research, the control group will be assured that after the completion of the research period, if they wish, a similar program will be organized for 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>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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Arezu Mohammad Ebrahim zadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Taftazani 10 st, No 14,16</address>
        <city>Shirvan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9461791986</zip>
        <telephone>+98 915 983 5569</telephone>
        <email>arezumohamadebrahimzade@gmail.com</email>
        <affiliation>Bojnourd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Arezu Mohammad Ebrahim zadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Taftazani 10 st, No 14,16</address>
        <city>Shirvan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9461791986</zip>
        <telephone>+98 915 983 5569</telephone>
        <email>arezumohamadebrahimzade@gmail.com</email>
        <affiliation>Bojnourd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age over 60 years
Not suffering from cognitive disorders or types of dementia
Having the ability to participate in art therapy courses and drawing and making crafts
Ability to speak and understand persian
Not having physical-motor disabilities or types of neurological and movement disorders (plegia or Parkinson's) severe enough to interfere with group therapy programs
Not having a known mood disorder (major depression or anxiety)</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Failure to participate in one or more sessions of group art therapy programs
Failure to complete the questionnaire in the post-exam phase
Suffering from any debilitating physical and mental illness
Hospitalization</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>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In this study, the intervention includes group art therapy. Group art therapy based on painting and music in this research includes 12 sessions (one month) that are held three days a week (Saturday, Monday, Wednesday or Sunday, Tuesday and Thursday), and each session lasts for one hour. It will be held in three parts: warm-up, program implementation and summation. The venue is a room in the care centers for the elderly. Each group will receive a total of twelve intervention sessions. Each art therapy session begins with a 10-minute warm-up. In these 10 minutes, the researcher warms up the members for that meeting by telling a story related to the topic of that meeting and introducing an activity related to the same meeting, and then 30 minutes to implement the special and predetermined program of that meeting and the last 20 minutes to The presentation of each person's artwork and the discussion between the group members are assigned. For each session, a predetermined program is developed, which includes painting with different techniques and with different materials and methods, such as making a tag for one's own name, preparing by using warm-up techniques such as scribble and finding images in between. Draw lines and color them, draw (draw a front view), draw a family member as an animal, draw (an animal he likes to be) as an art activity, draw his own and others' faces, draw a gift he likes to receive and give a gift to his family members, expressing one's thoughts by performing a practical task, creating a book of life with a drawing (various topics such as the first and most important memory he had from childhood to the present day or the most important event in his life or three wishes who likes to be fulfilled), finger painting by listening to three wordless music (first lively and then sad and finally relaxing), review of previous sessions and integration of achievements presented by the researcher. The last meeting includes summarizing and preparing people to finish the meetings.</i_keyword>
      <i_keyword>Control group: Control group: For the control group, the normal daily program of nursing homes will be implemented and no art therapy intervention will be done. In order to respect the rights of the elderly and prevent any unpleasant feelings or discrimination, in addition to explaining the conditions of the research, the control group will be assured that after the completion of the research period, if they wish, a similar program will be organized for them.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety. Timepoint: Before the intervention and two weeks after the last intervention session. Method of measurement: Depression, anxiety and stress scale DASS-21.</prim_outcome>
      <prim_outcome>Stress. Timepoint: Before the intervention and two weeks after the last intervention session. Method of measurement: Depression, anxiety and stress scale DASS-21.</prim_outcome>
      <prim_outcome>Depression. Timepoint: Before the intervention and two weeks after the last intervention session. Method of measurement: Depression, anxiety and stress scale DASS-21.</prim_outcome>
      <prim_outcome>Loneliness. Timepoint: Before the intervention and two weeks after the last intervention session. Method of measurement: De Jong-Girold Loneliness 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>Bojnourd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-01-22</approval_date>
        <contact_name>Ethics Committee of North Khorasan University of Medical Sciences</contact_name>
        <contact_address>Taftazani 10 st, No 14,16 Shirvan North Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
