<?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>IRCT20210315050712N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-08-19</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Scheduled Appointments on Family Intensive Care Unit Syndrome</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Scheduled Appointments on Family Intensive Care Unit Syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65292</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: Randomization of the study is done by simple random method. At first, two hospitals or two general ICU departments that have more beds and the same conditions in terms of equipment and the same rules and restrictions are selected. Among the family members of patients hospitalized in the relevant departments and those who meet the criteria for entering the study, two intervention and control groups will be selected according to the odd and even file number. In this way, patients are identified with an even file number in the control group and an odd number in the intervention group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Family Intensive Care Unit Syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Before entering the ward, hands are washed according to the instructions and gloves and gowns are worn. In the first meeting with the patient, which will be in the presence of the researcher, according to the doctor's opinion, based on the needs and conditions of the patient and the desire of the family members, participation in daily life activities such as position change and massage will be done. In the next session, depending on the patient's needs, participation in mouthwash or patient nutrition is done in addition to the previous two cares. In the remaining sessions, all contributions will be made depending on the patient's needs. Completing the syndrome list of the patient's family in the intensive care unit is designed in person or by press line and is completed by the research sample (one of the family members). After that, according to the opinion of the visiting person, care training sessions will be arranged and face-to-face in one to two sessions based on the needs of the person, and then a phone number will be provided to them to answer questions. Intervention 2: Control group: This group will use the routine rules of the intensive care unit of the hospital for visits. Four meetings will be held in accordance with the regulations and restrictions of the department and at the time of the meeting in one week. The control group also receives training related to special care department regulations and meeting hours and compliance with health protocols for special care patients in the form of pamphlets and educational clips. Completing the syndrome list of the patient's family in the intensive care unit is designed in person or by press line and is completed by the research sample (one of the family members). After that, according to the opinion of the visiting person, training sessions will be arranged and face-to-face in one to two sessions based on the needs of the person, and then a phone number will be provided to them to answer questions.</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maedeh Abedi Dorcheh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 35, Unit 3, Kerman St., Mousavi St., Majidieh District, Resalat Highway, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1634678694</zip>
        <telephone>+98 21 2624 4174</telephone>
        <email>maedeh.abedi67@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Leila Khanali Mojn</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, Wali Asr St., Niayesh Intersection, in front of Shahid Rajaee Heart Hospital, Faculty of Nursing and Midwifery</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 8865 5366</telephone>
        <email>leilakhanali@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Family members of patients hospitalized in the intensive care unit for more than 24 hours
First degree relatives of patients
Absence of self-reported mental disorders
Voluntary participation in the study
Absence of sensory disorders such as vision or hearing problems affecting learning</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Lack of doctor's permission for the participation of family members in care
Unwillingness to participate in the study
Self-reported presence of mental disorders
Lack of alertness and full awareness of place, time, person, as well as the ability to speak
The presence of sensory disorders such as vision or hearing problems affecting learning</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>Prevention</i_code>
      <i_code>Diagnosis</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Before entering the ward, hands are washed according to the instructions and gloves and gowns are worn. In the first meeting with the patient, which will be in the presence of the researcher, according to the doctor's opinion, based on the needs and conditions of the patient and the desire of the family members, participation in daily life activities such as position change and massage will be done. In the next session, depending on the patient's needs, participation in mouthwash or patient nutrition is done in addition to the previous two cares. In the remaining sessions, all contributions will be made depending on the patient's needs. Completing the syndrome list of the patient's family in the intensive care unit is designed in person or by press line and is completed by the research sample (one of the family members). After that, according to the opinion of the visiting person, care training sessions will be arranged and face-to-face in one to two sessions based on the needs of the person, and then a phone number will be provided to them to answer questions.</i_keyword>
      <i_keyword>Control group: This group will use the routine rules of the intensive care unit of the hospital for visits. Four meetings will be held in accordance with the regulations and restrictions of the department and at the time of the meeting in one week. The control group also receives training related to special care department regulations and meeting hours and compliance with health protocols for special care patients in the form of pamphlets and educational clips. Completing the syndrome list of the patient's family in the intensive care unit is designed in person or by press line and is completed by the research sample (one of the family members). After that, according to the opinion of the visiting person, training sessions will be arranged and face-to-face in one to two sessions based on the needs of the person, and then a phone number will be provided to them to answer questions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Family Intensive Care Unit Syndrome. Timepoint: At entering the study (before the intervention), at the end of the first week and at the end of the planned visits. Method of measurement: The incidence of this syndrome is measured by the score that people get from filling out the syndrome list of the special care patient's family. This list has 31 terms in two dimensions of psychological threat with 17 terms and non-psychological dimension with 14 terms. Scoring on a five-point Likert scale is always (five), usually (four), sometimes (three), rarely (two), never (one). Total scores range from 31 to 155. Based on this, the more points a person gets from the family of the special care patient's syndrome list, the more it will indicate an increase in the special care patient's family syndrome.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-08-15</approval_date>
        <contact_name>Research Ethics Committees of School of Pharmacy and Nursing &amp; Midwifery- Shahid Beheshti University</contact_name>
        <contact_address>No. 35, Shahid Mousavi Ave., Kerman Street., Resalat Blvd Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
