<?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>IRCT20190917044802N12</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-01-10</date_registration>
      <primary_sponsor>Fasa University of Medical Sciences</primary_sponsor>
      <public_title>The effect of implementing the family-centered empowerment model on psychological well-being and health-promoting lifestyle in multiple sclerosis patients</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of implementing the family-centered empowerment model on psychological well-being and health-promoting lifestyle in multiple sclerosis patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-01-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/81093</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: 60 cards are placed in a sealed envelope. 30 cards are put on stickers (A intervention group) and labels are placed on other 30 cards (B control group). Then the patients participating in the study are asked to take one of the cards. People who take card A will be in the intervention group and people who take card B will be in the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Multiple sclerosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: For the intervention group, a training program based on the family-centered empowerment model will be implemented. The stages of the family-centered empowerment model will include four stages: 1- Understanding the threat, 2- Improving self-efficacy, 3- Self-belief and increasing self-confidence, 4. Evaluation. Step one, Understanding the threat: The first stage in the family-centered empowerment model is to increase perceived severity and sensitivity. The purpose of perceived severity (awareness and knowledge of the individual about the disease) is for the individual to understand the seriousness of the disease by recognizing the risks or complications of the disease and to feel threatened by it. Step two, Self-efficacy: Problem solving or problem solving will be implemented in a group method. For this purpose, problem solving sessions (two 40- to 60-minute sessions) will be held for a group of patients and their families. Step three, Self-belief and increasing self-confidence: In this stage, the patient will be asked to teach the family the material discussed in the previous sessions during a session and to do this with the researcher's help and guidance if needed. The goal of this stage is to increase patients' self-confidence by observing their ability to provide information to family members and support them. Step Four, Evaluation: The evaluation of the process during the empowerment sessions will be carried out in such a way that the educational materials of the previous sessions are evaluated in the form of questions and answers in the next session. Intervention 2: Control group: The control group will only receive the educational package and will not receive the educational intervention.</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 the questionnaires used in this study as well as the content of the training program will be provided to the applicants.

When:
The time period for accessing the data is after the publication of the article extracted from the study and there is no time limit.

To whom:
Researchers, nursing managers and hospital management can send their request to use the
results of this research to the responsible author Mostafa Bijani in writing. Tell: 09173308451
Email:bizhani_mostafa@yahoo.com

Conditions:
Nursing managers in the psychiatric department can use the results of this research to develop training programs for patients and patients' families.

Where to obtain:
Researchers can send their request to use the results of this research to the responsible
author Mostafa Bijani in writing. Tell: 09173308451 Email:bizhani_mostafa@yahoo.com

How to obtain:
Sending the request for the use of research documents and results to the responsible author
and sending the results by the responsible author to the requesting person Tell: 09173308451
Email:bizhani_mostafa@yahoo.com

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mostafa  Bijani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ibn Sina Square</address>
        <city>Fasa</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7461686688</zip>
        <telephone>+98 917 330 8451</telephone>
        <email>bizhani_mostafa@yahoo.con</email>
        <affiliation>Fasa University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mostafa Bijani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ibn Sina Square</address>
        <city>Fasa</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7461686688</zip>
        <telephone>+98 917 330 8451</telephone>
        <email>bizhani_mostafa@yahoo.com</email>
        <affiliation>Fasa University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness to participate in the study
Being literate in reading and writing
Having at least a 6-month history of multiple sclerosis</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Absence of more than two sessions in training sessions
Aggravation and worsening of the disease
Unwillingness to continue participating in the study for any reason</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G35</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Multiple sclerosis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: For the intervention group, a training program based on the family-centered empowerment model will be implemented. The stages of the family-centered empowerment model will include four stages: 1- Understanding the threat, 2- Improving self-efficacy, 3- Self-belief and increasing self-confidence, 4. Evaluation. Step one, Understanding the threat: The first stage in the family-centered empowerment model is to increase perceived severity and sensitivity. The purpose of perceived severity (awareness and knowledge of the individual about the disease) is for the individual to understand the seriousness of the disease by recognizing the risks or complications of the disease and to feel threatened by it. Step two, Self-efficacy: Problem solving or problem solving will be implemented in a group method. For this purpose, problem solving sessions (two 40- to 60-minute sessions) will be held for a group of patients and their families. Step three, Self-belief and increasing self-confidence: In this stage, the patient will be asked to teach the family the material discussed in the previous sessions during a session and to do this with the researcher's help and guidance if needed. The goal of this stage is to increase patients' self-confidence by observing their ability to provide information to family members and support them. Step Four, Evaluation: The evaluation of the process during the empowerment sessions will be carried out in such a way that the educational materials of the previous sessions are evaluated in the form of questions and answers in the next session.</i_keyword>
      <i_keyword>Control group: The control group will only receive the educational package and will not receive the educational intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Psychological well-being. Timepoint: Before the intervention, immediately and three months after the intervention. Method of measurement: Ryff’s Psychological Well-Being  Questionnaire.</prim_outcome>
      <prim_outcome>Health Promoting Lifestyle. Timepoint: Before the intervention, immediately and three months after the intervention. Method of measurement: Walker et al. Health Promoting Lifestyle Questionnaire.</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>Fasa University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-12-17</approval_date>
        <contact_name>Ethics committee of Fasa University of Medical Sciences</contact_name>
        <contact_address>Ibn Sina Square Fasa Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
