<?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>IRCT20250514065734N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-06-10</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of visual art therapy on daily living activities and self-efficacy of the elderly.</public_title>
      <acronym></acronym>
      <scientific_title>Effect of visual art therapy on activities of daily living and self-Efficacy in elderly</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-08-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/84155</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: 60 samples are randomly sequenced in a random block of four using the randomization site (for example: AABB, ABAB, BAAB,.....). In each block, two people are randomly assigned to the intervention group and two people to the control group. After the random sequence is determined, we consider the letters A to be the intervention group and the letters B to be the control group. They are placed in sealed envelopes in sequence and the envelopes are numbered 1 to 60. When sampling, individuals receive the envelope corresponding to their number in the order in which they enter the study. After opening the envelope, individuals are assigned to the control or intervention group according to the letter written.</study_design>
      <phase>N/A</phase>
      <hc_freetext>elderly.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the intervention group, the art therapy program will be held over 4 weeks in 8 sessions (60 to 150 minutes). The sessions will be held in a quiet, well-lit environment and in a well-equipped classroom. This intervention is designed based on the MOLACE program and includes creative activities such as painting, drawing, decorating, and craft making. The eighth session will be dedicated to displaying the created artworks. Each session will be divided into four stages: introduction and preparation (5-10 minutes), performing the art activity (30-50 minutes), sharing the work and expressing emotions (20-50 minutes), and ending the session (5-10 minutes). Also, the sessions are designed so that the elderly share their artwork and express their emotions at the end of each session. The art activities in this program are designed to help strengthen the physical and mental dimensions of the elderly on the one hand, and to improve the quality of social communication and the feeling of satisfaction with life in the elderly on the other. The ultimate goal is that through this intervention, seniors will have more positive feelings about their daily lives. Intervention 2: Control group: Elderly people will receive routine care at the day care center or health center. The day care center for the elderly provides services in the fields of education, rehabilitation, recreation and daily care. In this center, educational classes such as language, music, painting and life skills are held, as well as sports programs such as yoga, stretching, walking. Physiotherapy and psychological counseling services are available. Participation in group activities, celebrations and cultural events, as well as health monitoring, including blood pressure and blood sugar control, are carried out regularly. Healthy nutrition is provided by providing breakfast and lunch, and if necessary, a shuttle service, is another facility of the center. The health center regularly monitors the health status of the elderly by conducting periodic examinations, screening for blood pressure, blood sugar, lipids, vision, hearing, depression and memory. Necessary education about healthy nutrition, age-appropriate physical activity, medication use and disease prevention is also provided to the elderly and their families. Psychological and social counseling to reduce anxiety, loneliness, and depression of the elderly is also provided in the form of individual or group counseling programs. In addition, training of caregivers of the elderly in the family is also considered to provide a safer and healthier environment for the elderly at home. Holding group meetings, light sports programs, and social activities to maintain the morale and interaction of the elderly are other supportive measures of the center.</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:
Things that explain the results of our intervention and limitations

When:
Access period starts 6 months after results are published.

To whom:
Research

Conditions:
Scientific research to help the aging society

Where to obtain:
Researchers' email

How to obtain:
At least 1 month

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Naser Jamshidi Bozorgi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razavi Khorasan, Mashhad, Azadi Square, East Gate of Ferdowsi University of Mashhad, University Campus, Shahid Dr. Kharazmi Educational Complex</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3884 6732</telephone>
        <email>jamshidibn4022@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Salehian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razavi Khorasan, Mashhad, Azadi Square, East Gate of Ferdowsi University of Mashhad, University Campus, Shahid Dr. Kharazmi Educational Complex</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3884 6732</telephone>
        <email>salehianmr@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age over 65 years
Having visual, auditory, and upper motor abilities
Absence of cognitive impairment
Having the ability to read and write</inclusion_criteria>
      <agemin>65 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having a debilitating disease during the study, such as Parkinson's, rheumatoid arthritis, stroke, etc., or possible injuries or fractures
The emergence of new medical conditions that make participation risky (e.g., stroke, heart attack, or advanced chronic diseases)
Severe and complete lack of dependence according to the Barthel questionnaire
Exacerbation of underlying diseases that prevent continued participation
Presence of a mental disorder (schizophrenia, severe depression) and severe cognitive disorder (dementia) and undergoing treatment according to the medical record
Failure to attend more than one intervention session
Loss of contact with the participant, migration of the participant to an area where access is difficult or impossible
Death of an elderly person</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>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the intervention group, the art therapy program will be held over 4 weeks in 8 sessions (60 to 150 minutes). The sessions will be held in a quiet, well-lit environment and in a well-equipped classroom. This intervention is designed based on the MOLACE program and includes creative activities such as painting, drawing, decorating, and craft making. The eighth session will be dedicated to displaying the created artworks. Each session will be divided into four stages: introduction and preparation (5-10 minutes), performing the art activity (30-50 minutes), sharing the work and expressing emotions (20-50 minutes), and ending the session (5-10 minutes). Also, the sessions are designed so that the elderly share their artwork and express their emotions at the end of each session. The art activities in this program are designed to help strengthen the physical and mental dimensions of the elderly on the one hand, and to improve the quality of social communication and the feeling of satisfaction with life in the elderly on the other. The ultimate goal is that through this intervention, seniors will have more positive feelings about their daily lives.</i_keyword>
      <i_keyword>Control group: Elderly people will receive routine care at the day care center or health center. The day care center for the elderly provides services in the fields of education, rehabilitation, recreation and daily care. In this center, educational classes such as language, music, painting and life skills are held, as well as sports programs such as yoga, stretching, walking. Physiotherapy and psychological counseling services are available. Participation in group activities, celebrations and cultural events, as well as health monitoring, including blood pressure and blood sugar control, are carried out regularly. Healthy nutrition is provided by providing breakfast and lunch, and if necessary, a shuttle service, is another facility of the center. The health center regularly monitors the health status of the elderly by conducting periodic examinations, screening for blood pressure, blood sugar, lipids, vision, hearing, depression and memory. Necessary education about healthy nutrition, age-appropriate physical activity, medication use and disease prevention is also provided to the elderly and their families. Psychological and social counseling to reduce anxiety, loneliness, and depression of the elderly is also provided in the form of individual or group counseling programs. In addition, training of caregivers of the elderly in the family is also considered to provide a safer and healthier environment for the elderly at home. Holding group meetings, light sports programs, and social activities to maintain the morale and interaction of the elderly are other supportive measures of the center.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Level of daily living activities. Timepoint: Before the start of the study and after the end of the study. Method of measurement: Modified Barthel Index.</prim_outcome>
      <prim_outcome>Level of self-efficacy. Timepoint: Before the start of the study and after the end of the study. Method of measurement: Self-Efficacy Scale for Everyday Activities.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-05-20</approval_date>
        <contact_name>Research Ethics Committees of School of Nursing &amp; Midwifery - Mashhad University of Medical Sciences</contact_name>
        <contact_address>Razavi Khorasan, Mashhad, Azadi Square, East Gate of Ferdowsi University of Mashhad, University Campus, Shahid Dr. Kharazmi Educational Complex Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
