<?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>IRCT20150519022320N31</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-08-09</date_registration>
      <primary_sponsor>Rafsanjan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Eye Movement Desensitization and Reprocessing (EMDR) on kinesiophobia and ADL in elderly with musculoskeletal pain referring to outpatient clinicin Rafsanjan city in 2023.</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Eye Movement Desensitization and Reprocessing (EMDR) on kinesiophobia and ADL in elderly with musculoskeletal pain referring to outpatient clinicin Rafsanjan city in 2023.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>44</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71873</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 elderly who meet the inclusion criteria and listing them, they will be divided into 2 groups of 22 people, the intervention group and the control group, using a simple random division method using a random number table. People will be divided into two groups based on the random number table. 22 people A and B will be divided and finally two groups A and B will be placed in test and control groups based on lottery.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: kinesiophobia. Condition 2: Activities of Daily Living.</hc_freetext>
      <i_freetext>Intervention 1: The researcher will start the work after stating the goals and method of the study and obtaining the consent of the people to participate in the study. Participants will complete questionnaires of fear of movement and activities of daily living, for the eye movement desensitization and reprocessing (EMDR) intervention group in eight steps; (1. history taking and treatment design 2. preparation 3. examination and evaluation 4. desensitization 5. operation 6. physical examination 7. termination or closure 8. re-evaluation) is done. EMDR sessions will be conducted individually and face-to-face for 8 weeks and 3 sessions of 45 to 60 minutes each week (up to a maximum of 90 minutes) by the researcher (the first session by the therapist and under his supervision) for each elderly person. In this intervention, the patient creates scenes of fear of movement in his mind, and during EMDR movements, he follows the researcher's finger with eye movements to finally get rid of the confusion caused by movement phobia. Each finger movement takes approximately one to two seconds. Each finger movement cycle is 20 seconds or more. Then, at the end and one month after the end of the intervention, the aforementioned questionnaires will be completed again by the participants. Intervention 2: Control group: During the study period, there will be no intervention in the control group and the questionnaires will be completed by the participants.</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 Due to the lack of intervention</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Ali Ravari</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>ravary4776@yahoo.com</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Ali Ravari</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>ravary4776@yahoo.com</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
Not having severe hearing and vision problems
Obtaining a score higher than 18 from the TSK questionnaire
No addiction and use of neuropsychiatric drugs
Having musculoskeletal pain for 6 months
Obtain informed consent
Not having diseases like Parkinson's and Korea
No bereavement and acute mental problems in the last 6 months</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Lack of informed consent
Non-cooperation based on the programs taught
Taking psychotherapeutic drugs effective on kinesiophobia (such as antidepressants and anti-anxiety drugs)
Conducting other psychotherapeutic interventions such as CBT on kinesiophobia</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The researcher will start the work after stating the goals and method of the study and obtaining the consent of the people to participate in the study. Participants will complete questionnaires of fear of movement and activities of daily living, for the eye movement desensitization and reprocessing (EMDR) intervention group in eight steps; (1. history taking and treatment design 2. preparation 3. examination and evaluation 4. desensitization 5. operation 6. physical examination 7. termination or closure 8. re-evaluation) is done. EMDR sessions will be conducted individually and face-to-face for 8 weeks and 3 sessions of 45 to 60 minutes each week (up to a maximum of 90 minutes) by the researcher (the first session by the therapist and under his supervision) for each elderly person. In this intervention, the patient creates scenes of fear of movement in his mind, and during EMDR movements, he follows the researcher's finger with eye movements to finally get rid of the confusion caused by movement phobia. Each finger movement takes approximately one to two seconds. Each finger movement cycle is 20 seconds or more. Then, at the end and one month after the end of the intervention, the aforementioned questionnaires will be completed again by the participants.</i_keyword>
      <i_keyword>Control group: During the study period, there will be no intervention in the control group and the questionnaires will be completed by the participants.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Kinesiophobia of the elderly with musculoskeletal pain. Timepoint: All participants will complete the Tampa Fear of Movement Questionnaire (TSK) before and after the intervention and one month after the end of the intervention. Method of measurement: Fear of Movement Tampa Questionnaire (TSK).</prim_outcome>
      <prim_outcome>Activities of Daily Living in the elderly with musculoskeletal pain. Timepoint: All participants will complete ADL and IADL questionnaires before and after the intervention and one month after the end of the intervention. Method of measurement: ADL and IADL questionnaires.</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>2023-08-07</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>
