<?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>IRCT20200811048368N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-10-11</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of the nurse's intentional presence on coping, stress and anxiety  of patients undergoing intestinal obstruction</public_title>
      <acronym></acronym>
      <scientific_title>The effect of the nurse's intentional presence based on holistic approach on coping, stress and anxiety  of patients undergoing intestinal obstruction surgeries</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-11-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>10</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50250</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: For randomization, blocks of size 4 or 6 will be used to increase the unpredictability of produced random sequence. To hide the generated sequence, envelopes will be numbered and opened for each participant sequentially to determine their group, Blinding description: It is explained to the patient that the patient will participate in a research study, but it is not explained which groups they will be allocated because patient's responses do not be affected by the results of the study and also the statistical analyst only has the statistical data and doesn't know about group of each patient.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Intestinal obstruction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: the intervention is the intentional presence of the holistic nurse which is based on the theories of holistic presence in three levels (physical, psychological and therapeutic) and holistic nurse's intentionality. According to this approach the nurse should start her nursing care based on the patient's trust and his/her exact needs. This research is planned in 5 holistic nursing care meetings in about 30-45 minutes. The research environment is the surgical ward, 24 hours after the surgery. In each session the researcher tries to be in an empathic relationship with the patient in which the patient would trust to the researcher. The intention to improve the patient's needs is the most important antecedent of each therapeutic relationship. Then the patient will release her emotions and tell the researcher about her/his actual needs. In this situation the researcher tries to use the holistic need assessment scale to help the patient to declare all of the needs (physical, psychological, social and spiritual needs). Then the researcher tries to sort the patient's needs from the most important to the less, and design a nursing care plan for the patient according to her/his needs. Simultaneously the researcher gives a self care education application to the patient which has all of the educational contents for the patients with bowel obstruction. The nursing care plan is unique for each patient. The intentional presence meetings will be started at the hospital and continued after discharge during one month at least 2 times in a week. It should be mentioned that the patients would give all of the routine treatments. Intervention 2: Control group: the patients in control group will give all of the routine cares and treatments such as monitoring vital signs, wound care, serum therapies, spacial drugs and treatments. All of the educational pamphlets would be given to the patients during the hospitalization and after the discharge. If the patient will have a colostomy, she/he would refer to a specialist nurse to learn about taking care of her/his colostomy.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahboubeh Kavousi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>90.1, Emammat 29, Emammat Blvd</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9188667334</zip>
        <telephone>+98 51 3605 8400</telephone>
        <email>kavousim971@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahboubeh Kavousi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>NO. 90.1; Emammat 29; Emammat boulevard</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9188667334</zip>
        <telephone>+98 918 866 7334</telephone>
        <email>kavousim971@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having informed consent
Ability to read and write
being hospitalized &lt; 1 month
Age between 20-70 years old
Bowel resection length &lt; 120 cm
Having a smartphone  patient or one of the family members)
Ability to use smartphone ( by the patient or the key family member that is called the care giver)</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Drug addiction
Occurrence of metastasis during the research
Suffering from short bowel syndrome</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K56.69</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other intestinal obstruction</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: the intervention is the intentional presence of the holistic nurse which is based on the theories of holistic presence in three levels (physical, psychological and therapeutic) and holistic nurse's intentionality. According to this approach the nurse should start her nursing care based on the patient's trust and his/her exact needs. This research is planned in 5 holistic nursing care meetings in about 30-45 minutes. The research environment is the surgical ward, 24 hours after the surgery. In each session the researcher tries to be in an empathic relationship with the patient in which the patient would trust to the researcher. The intention to improve the patient's needs is the most important antecedent of each therapeutic relationship. Then the patient will release her emotions and tell the researcher about her/his actual needs. In this situation the researcher tries to use the holistic need assessment scale to help the patient to declare all of the needs (physical, psychological, social and spiritual needs). Then the researcher tries to sort the patient's needs from the most important to the less, and design a nursing care plan for the patient according to her/his needs. Simultaneously the researcher gives a self care education application to the patient which has all of the educational contents for the patients with bowel obstruction. The nursing care plan is unique for each patient. The intentional presence meetings will be started at the hospital and continued after discharge during one month at least 2 times in a week. It should be mentioned that the patients would give all of the routine treatments.</i_keyword>
      <i_keyword>Control group: the patients in control group will give all of the routine cares and treatments such as monitoring vital signs, wound care, serum therapies, spacial drugs and treatments. All of the educational pamphlets would be given to the patients during the hospitalization and after the discharge. If the patient will have a colostomy, she/he would refer to a specialist nurse to learn about taking care of her/his colostomy.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Coping. Timepoint: Before  the intervention, discharge time and 27 days later. Method of measurement: The Filipino Coping Strategies scale.</prim_outcome>
      <prim_outcome>Stress. Timepoint: Before the intervention, 72 hours after the intervention, discharge time, 27 days after the intervention. Method of measurement: Depression, Anxiety, Stress scale  DASS- 21 scale.</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: Before the intervention, 72 hours after the intervention, discharge time, 27 days after the intervention. Method of measurement: Depression, Anxiety, Stress scale (DASS- 21 scale).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The patient's weight. Timepoint: Before the intervention, at discharge time and 27 days after the intervention. Method of measurement: weight scale.</sec_outcome>
      <sec_outcome>Nutrition situation indices. Timepoint: Before the intervention, at discharge time and 27 days after the intervention. Method of measurement: Patient-Generated Subjective Global Assessment.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-06-30</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>NO. 90.1; Emammat 29; Emammat boulevard Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
