<?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>IRCT20220904055881N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-02-11</date_registration>
      <primary_sponsor>Tarbiat Modares University</primary_sponsor>
      <public_title>Effectiveness of Multifaceted Interventions on Reducing Musculoskeletal Pain in the Elderly</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of Multi Disciplinary Interventions Based on Health Belief Model on Musculoskeletal Pain in the Elderly Living in Nursing Homes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-11-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65774</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: The use of multifaceted interventions to reduce Musculoskeletal pain in the elderly is one of the innovative aspects of this plan, Randomization description: The sampling method is cluster sampling. Tehran is divided into four regions: north, south, west, and east. The lottery method is used to select nursing homes in each region. A number is considered for each nursing home. Then the numbers are written on the paper. The papers are placed in a container and stirred well. Then two cards are selected from among the papers. The first card is considered as the intervention group and the second card as the control. Then, from each center, the elderly who meet the entry criteria are identified and selected. The sample size in each group is 60 people (60 people in the intervention group and 60 people in the control group).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Other osteoporosis without current pathological fracture. Condition 2: Osteoarthritis, unspecified site. Condition 3: Gout, unspecified.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Physiotherapy includes training, maintaining correct body posture while standing, walking, and sitting by a physiotherapist for four to six 45-minute sessions and training walking for at least 30 minutes a day. Training reducing stress and anxiety including deep breathing, sleep regulation, etc. by a psychologist for four 45-minute sessions. Vitamin D intake includes training on how to consume vitamin D and its benefits by a doctor (every month one vitamin D tablet of 50,000 units is given to the elderly in the intervention group). the number of training sessions based on the Health belief model structures to change the beliefs of the elderly is determined based on confirmatory factor analysis. Intervention sessions will be held weekly (one session per week). The training sessions will last one to two months, but at least six months of vitamin D tablets are required to be effective, so the duration of the intervention will be six months. Intervention 2: Control group: It includes elderly people living in Nursing Homes who will not receive any intervention during the research period. They will complete the questionnaire before the intervention, immediately, three and six months after the intervention. The results of this group will be compared and statistically analyzed with the intervention 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:
Information about the primary outcome can be shared.

When:
The access period will start six months after the results are published.

To whom:
Data for researchers, people working in universities and scientific institutions

Conditions:
Evaluating the outcome of data analysis and verifying its correctness under the conditions of double-blindness

Where to obtain:
Via email tavafian@modares.ac.ir

How to obtain:
Via email tavafian@modares.ac.ir

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sedigheh Sadat Tavafian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Medical sciences., Tehran Modares University., Nasar Bridge ., Jalal Al Ahmad Highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417113116</zip>
        <telephone>+98 912 287 6439</telephone>
        <email>tavafian@modares.ac.ir</email>
        <affiliation>Tarbiat Modares University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sedigheh Sadat Tavafian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Medical sciences., Tehran Modares University., Nasar Bridge ., Jalal Al Ahmad Highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417113116</zip>
        <telephone>+98 912 287 6439</telephone>
        <email>tavafian@modares.ac.ir</email>
        <affiliation>Tarbiat Modares University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People Aged 60 and over Living in a Nursing Home
Ability to Perform Physical Activity
Ability to Answer Questions</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Elderly People with Alzheimer's Disease
Elderly with Mobility Disabilities
Elderly People Who Use Medicine to Control Pain</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M81.8</hc_code>
      <hc_code>M19.9</hc_code>
      <hc_code>M10.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other osteoporosis without current pathological fracture</hc_keyword>
      <hc_keyword>Osteoarthritis, unspecified site</hc_keyword>
      <hc_keyword>Gout, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Physiotherapy includes training, maintaining correct body posture while standing, walking, and sitting by a physiotherapist for four to six 45-minute sessions and training walking for at least 30 minutes a day. Training reducing stress and anxiety including deep breathing, sleep regulation, etc. by a psychologist for four 45-minute sessions. Vitamin D intake includes training on how to consume vitamin D and its benefits by a doctor (every month one vitamin D tablet of 50,000 units is given to the elderly in the intervention group). the number of training sessions based on the Health belief model structures to change the beliefs of the elderly is determined based on confirmatory factor analysis. Intervention sessions will be held weekly (one session per week). The training sessions will last one to two months, but at least six months of vitamin D tablets are required to be effective, so the duration of the intervention will be six months.</i_keyword>
      <i_keyword>Control group: It includes elderly people living in Nursing Homes who will not receive any intervention during the research period. They will complete the questionnaire before the intervention, immediately, three and six months after the intervention. The results of this group will be compared and statistically analyzed with the intervention group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Musculoskeletal pains. Timepoint: Before the intervention, immediately, 3, and 6 months after completing the educational intervention. Method of measurement: Questionnaire Made by the Researcher.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Knowledge. Timepoint: Before the intervention, immediately, 3, and 6 months after completing the educational intervention. Method of measurement: Questionnaire made by the researcher.</sec_outcome>
      <sec_outcome>Perceived Susceptibility. Timepoint: Before the intervention, immediately, 3, and 6 months after completing the educational intervention. Method of measurement: Questionnaire made by the researcher.</sec_outcome>
      <sec_outcome>Perceived Severity. Timepoint: Before the intervention, immediately, 3, and 6 months after completing the educational intervention. Method of measurement: Questionnaire made by the researcher.</sec_outcome>
      <sec_outcome>Perceived Barriers. Timepoint: Before the intervention, immediately, 3, and 6 months after completing the educational intervention. Method of measurement: Questionnaire made by the researcher.</sec_outcome>
      <sec_outcome>Perceived Benefits. Timepoint: Before the intervention, immediately, 3, and 6 months after completing the educational intervention. Method of measurement: Questionnaire made by the researcher.</sec_outcome>
      <sec_outcome>Cues to Action. Timepoint: Before the intervention, immediately, 3, and 6 months after completing the educational intervention. Method of measurement: Questionnaire made by the researcher.</sec_outcome>
      <sec_outcome>Self-Efficcy. Timepoint: Before the intervention, immediately, 3, and 6 months after completing the educational intervention. Method of measurement: Questionnaire made by the researcher.</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>Tarbiat Modares University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-08-27</approval_date>
        <contact_name>Ethics Committee of Tarbiat Modares  University of Medical Sciences</contact_name>
        <contact_address>Tehran Modares University., Nasar Bridge ., Jalal Al Ahmad Highway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
