<?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>IRCT20220401054380N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-02-11</date_registration>
      <primary_sponsor>Rasht University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Art therapy on quality of life in elderly women : A randomized controlled trial</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Art therapy on quality of life in elderly women : A randomized controlled trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-02-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>76</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/80305</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Based on the daily visits of the elderly, they are called to the center and if they meet the inclusion criteria, they will be included in the study. Based on four random blocks, the sequence of which will be obtained through the online random allocation software, into two groups A (art therapy)  (and group B) random allocation control. According to the sample size in two groups (n = 76) (19), there will be four random blocks in the random allocation sequence. The list of blocks sequence is placed in the envelope in the package.  After the permission from the research vice-chancellor, it is read daily during the implementation of the study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>quality of life.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In each art therapy session, the intervention group supervises the implementation of each participant by explaining the working method in that session. The contents of the sessions are implemented through the use of different arts in a way that promotes relaxation and introspection and mental imagery of a situation.  In which the person is located and to create a connection of emotions in people. In the welcome session, the sessions are conducted by the trainer. The warm-up exercise is to create relaxation and prepare people to enter the main exercise (each session).  This initial exercise is planned by creating visualization for people for the main exercise that is aimed at describing the beginning of each situation or its solutions.  Then, the practice of each session is done according to the content of that session by using accessible and low-cost art tools in a way that can put the person in the current mental state. After each exercise, people are asked to express their feelings and then  The instructor will help each person to understand his art product. At the end of each session, the participants will take their artwork home. At the end of each session, they will practice relaxation using music and mental imagery to be in a pleasant atmosphere.  It is done along with breathing exercises.  On average, the warm-up, relaxation and guided imagery phase will take 7-10 minutes;  The stage of artistic output will last 60 minutes and the stage of verbal development will take 15 to 20 minutes. Table 1. Content, purpose and time of art therapy sessions.  Construction of the current situation of the exercise: relaxation, listening to silent music and relaxation, the purpose of introducing and getting to know the people of the group, self-expression, time: 10 minutes, the second session, warming up the color spot, exercise: the main full-length picture, painting the worst fears and threatening situations, relaxation exercise, closing the eyes and imagining  A calming place, the purpose of expressing anger, fear: time 90 minutes, the third session, warm exercise: making contrasting colors, lines and shapes, exercise: main envelope and: face painting box, make yourself a symbol of your talents or capabilities by drawing or collage drawing a circle of support  and relaxation table, relaxation exercise, looking at the mirror and self-love, a valuable goal, ability, support, time 90 minutes, the fourth session, warm-up exercise, making your own symbol with clay, the main exercise of making seasons with clay, making a nest tree, a bird, and a storm-stricken tree, writing a letter to  God and a letter to his wife, practicing calming breathing and gratitude music: purpose, vision, solution, hope and future, time 90 minutes. Intervention 2: Control group: During this period, no art therapy services will be provided for the control group.</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:
All potential data can be shared after de-identifying individuals.

When:
The access period starts 6 months after the results are published.

To whom:
Researchers working in academic and scientific institutions.

Conditions:
All researchers in academic and scientific institutions will be able to use and analyze the data and results of the study for their future research.

Where to obtain:
The receive data, refer to the email address below:
najafzade.fateme.7726@gmail.com

How to obtain:
The applicant must send a valid certificate for his employment in academic and scientific institutions to the relevant email, and if the information is valid, the data will be emailed to him within a maximum of one month.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Najafzadeh Shavaki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 80, Abbaspur Alley, 72 Tan St</address>
        <city>Rudsar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4481834596</zip>
        <telephone>+98 13 4262 0549</telephone>
        <email>najafzade.fateme.7726@gmail.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Najafzadeh Shavaki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 80, Abbaspur Alley, 72 Tan St</address>
        <city>Rudsar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4481834596</zip>
        <telephone>+98 13 4262 0549</telephone>
        <email>najafzade.fateme.7726@gmail.com</email>
        <affiliation>Rasht 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>
    </countries>
    <criteria>
      <inclusion_criteria>Elderly women 60 years old and over 60 years old
Willingness to participate in research
Being literate in reading and writing</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria></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: In each art therapy session, the intervention group supervises the implementation of each participant by explaining the working method in that session. The contents of the sessions are implemented through the use of different arts in a way that promotes relaxation and introspection and mental imagery of a situation.  In which the person is located and to create a connection of emotions in people. In the welcome session, the sessions are conducted by the trainer. The warm-up exercise is to create relaxation and prepare people to enter the main exercise (each session).  This initial exercise is planned by creating visualization for people for the main exercise that is aimed at describing the beginning of each situation or its solutions.  Then, the practice of each session is done according to the content of that session by using accessible and low-cost art tools in a way that can put the person in the current mental state. After each exercise, people are asked to express their feelings and then  The instructor will help each person to understand his art product. At the end of each session, the participants will take their artwork home. At the end of each session, they will practice relaxation using music and mental imagery to be in a pleasant atmosphere.  It is done along with breathing exercises.  On average, the warm-up, relaxation and guided imagery phase will take 7-10 minutes;  The stage of artistic output will last 60 minutes and the stage of verbal development will take 15 to 20 minutes. Table 1. Content, purpose and time of art therapy sessions.  Construction of the current situation of the exercise: relaxation, listening to silent music and relaxation, the purpose of introducing and getting to know the people of the group, self-expression, time: 10 minutes, the second session, warming up the color spot, exercise: the main full-length picture, painting the worst fears and threatening situations, relaxation exercise, closing the eyes and imagining  A calming place, the purpose of expressing anger, fear: time 90 minutes, the third session, warm exercise: making contrasting colors, lines and shapes, exercise: main envelope and: face painting box, make yourself a symbol of your talents or capabilities by drawing or collage drawing a circle of support  and relaxation table, relaxation exercise, looking at the mirror and self-love, a valuable goal, ability, support, time 90 minutes, the fourth session, warm-up exercise, making your own symbol with clay, the main exercise of making seasons with clay, making a nest tree, a bird, and a storm-stricken tree, writing a letter to  God and a letter to his wife, practicing calming breathing and gratitude music: purpose, vision, solution, hope and future, time 90 minutes.</i_keyword>
      <i_keyword>Control group: During this period, no art therapy services will be provided for the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life score  in LEIPAD quality of life questionnaire. Timepoint: At the beginning of the study (before the start of the intervention) and immediately after the end of the intervention and 8 weeks after the end of the intervention. Method of measurement: LEIPAD quality of life questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of life score  in LEIPAD quality of life questionnaire. Timepoint: At the beginning of the study (before the start of the intervention) and immediately after the end of the intervention and 8 weeks after the end of the intervention. Method of measurement: LEIPAD quality of life 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>Rasht University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-11-13</approval_date>
        <contact_name>Ethics committee of Guilan University of Medical Sciences</contact_name>
        <contact_address>Ibn Sina Street, Faculty of Nursing, Midwifery and Para medicine, East Guilan Langrud Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
