<?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>IRCT20240806062674N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-08-26</date_registration>
      <primary_sponsor>Shahre-kord University of Medical Sciences</primary_sponsor>
      <public_title>The effect of coloring on anxiety, loneliness and spiritual health</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Coloring Mandala on Existential Anxiety, Feeling Loneliness, and Spiritual Health of the Elderly</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-10-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/78616</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Blocking of two pairs: The researcher wrote down the different conditions of the two groups (4 conditions in total: 1 control, test 2 test, control 3 test, test 4 control, control) on 5 cards each in a sealed envelope These envelopes are placed in a box and the researcher does not know which group the studied units belong to before selecting the card
By taking one of the envelopes out of the box, the researcher determines which group the two elderly people participating in the study will belong to. This process continues until all 5 cards have been removed from the box. Then the cards are put back into the box and the random selection of cards is repeated.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Elderly.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: After an online search on http://www.free-mandalas.net, the researcher selects pre-drawn mandala designs that are suitable for the elderly population. Mandalas are not so complicated but still interesting and have clear, bold lines that are easy to see and can be easily colored by older people. The intervention will be done on each of the participants in the test group individually in the consultation room of the elderly care center. The researcher gives the older people in the intervention group detailed verbal explanations about the method for carrying out the intervention. Then, each elderly person will be given a box of 6 colored pencils (red, orange, yellow, green, blue, and purple) and the subjects paint mandala designs in the dimensions of A4 paper (21.0 cm x 29.7 cm) provided by the researcher in each session from simple to complex for 20 minutes from the periphery to the center of the circle for 4 consecutive weeks in 2 sessions per week (Saturdays and Tuesdays). The individual motifs are colored freely and according to the personal ideas of the participants. Immediately after coloring the last mandala design in the eighth session, the scales of existential anxiety, loneliness, and spiritual health are evaluated by the participants. Intervention 2: Control group: After the pre-test, the control group will only receive routine care from the nursing home staff. In this group, the researcher will answer the subjects' questions about their state of health and the training they have received from the care staff. In this group, a post-test will be conducted after 4 weeks. The post-tests for the test and control groups will be carried out on different days. To comply with ethical considerations, the research method will be explained to the participants in the control group at the end so that they can also use this method if they wish.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Marzieh Borjian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahrekord University of Medical Sciences, Kashani Blvd., Shahrekord, Iran</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۸۸۱۵۷۱۳۴۷۱</zip>
        <telephone>+98 38 3333 0061</telephone>
        <email>m.borjian@yahoo.com</email>
        <affiliation>Shahre-kord University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Marzieh Borjian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahrekord University of Medical Sciences, Kashani Blvd., Shahrekord, Iran</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۸۸۱۵۷۱۳۴۷۱</zip>
        <telephone>+98 38 3333 0061</telephone>
        <email>m.borjian@yahoo.com</email>
        <affiliation>Shahre-kord University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>- Being at least 60 years old- Participant's consent to participate in the research- - People who are accommodated in a nursing home (separate from their family) - Not having a mental or physical disability based on the file information (the elderly person has the necessary visual, hearing and movement ability)- Not memory impairment or Alzheimer's disease according to the hospice doctor's diagnosis and the information in the file- Not having acute mental disorders based on the diagnosis of the hospital doctor and file information- Non-participation in other treatment courses at the same time- Not receiving psychiatric drugs for more than two weeks before the start of the intervention based on the report of the elderly and file information- At least 3 months have passed since the elderly person was in the nursing home- Not using temporary leave for more than one week during the study period</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>- Withdrawal of participants from continuing cooperation- Death of a participant during the study period- Absence from the intervention for more than two sessions- Occurrence of any kind of serious physical and mental illness leading to hospitalization of the elderly.- Taking medication for the nerves and psyche during the implementation of the intervention- Non-participation of the elderly in the assessments before or after the intervention</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>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: After an online search on http://www.free-mandalas.net, the researcher selects pre-drawn mandala designs that are suitable for the elderly population. Mandalas are not so complicated but still interesting and have clear, bold lines that are easy to see and can be easily colored by older people. The intervention will be done on each of the participants in the test group individually in the consultation room of the elderly care center. The researcher gives the older people in the intervention group detailed verbal explanations about the method for carrying out the intervention. Then, each elderly person will be given a box of 6 colored pencils (red, orange, yellow, green, blue, and purple) and the subjects paint mandala designs in the dimensions of A4 paper (21.0 cm x 29.7 cm) provided by the researcher in each session from simple to complex for 20 minutes from the periphery to the center of the circle for 4 consecutive weeks in 2 sessions per week (Saturdays and Tuesdays). The individual motifs are colored freely and according to the personal ideas of the participants. Immediately after coloring the last mandala design in the eighth session, the scales of existential anxiety, loneliness, and spiritual health are evaluated by the participants.</i_keyword>
      <i_keyword>Control group: After the pre-test, the control group will only receive routine care from the nursing home staff. In this group, the researcher will answer the subjects' questions about their state of health and the training they have received from the care staff. In this group, a post-test will be conducted after 4 weeks. The post-tests for the test and control groups will be carried out on different days. To comply with ethical considerations, the research method will be explained to the participants in the control group at the end so that they can also use this method if they wish.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Existential Anxiety. Timepoint: Before the start of the intervention - after the end of the intervention. Method of measurement: Good Existential Anxiety Scale (EAS).</prim_outcome>
      <prim_outcome>Feeling Loneliness. Timepoint: Before the start of the intervention - after the end of the intervention. Method of measurement: UCLA Loneliness Scale.</prim_outcome>
      <prim_outcome>Spiritual Health. Timepoint: Before the start of the intervention - after the end of the intervention. Method of measurement: Spiritual Health Scale (SWBS).</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>Shahre-kord University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-07-09</approval_date>
        <contact_name>Research Ethics Committees of Shahrekord University of Medical Sciences</contact_name>
        <contact_address>Kashani Blvd Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
