<?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>IRCT20200211046461N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-12</date_registration>
      <primary_sponsor>Babol University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Betty Neuman’s systems model on  Anxiety</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Betty Neuman’s systems model application on anxiety levels of elderly people candidate colonoscopy examination.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46724</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: Individuals with at least 50 percent of the total score of the needs assessment form will participate in the study as those with educational needs. According to the steps of the Betty Neuman nursing process, the intervention will be done in four stages. Thus, in the first stage, potential and actual stressors are identified based on the needs assessment form of Betty Newman model. It should be noted that the initial evaluation will be based on the Betty Neuman model for both groups and one week before the colonoscopy, and the anxiety questionnaire will be completed by individuals in both groups. In the second stage, appropriate goals and strategies (nursing diagnoses) for nursing measures are determined by strengthening the natural and flexible defense line. In the third stage, nursing interventions (training and counseling of clients) will be implemented based on the needs of clients.In this model, the purpose of strengthening the defensive lines of nursing interventions (training and counseling) according to the needs of the elderly about the structure, sequence, characteristics of the colonoscopy unit, as well as training on defining and explaining relaxation techniques, etc. Reduces the possibility of exposure to stressors and in some cases reduces the corresponding reactions. Only in the test group, individual intervention based on the training needs derived from the needs assessment form for each elderly person will be performed for 30-30 minutes. In the present study, the needs assessment form has already been developed. Educational content related to each of the items of the needs assessment form will be developed in each of the physiological, psychological, cultural-social, evolutionary and spiritual dimensions. Given that educational needs can vary from person to person, education and counseling are tailored to the needs of the elderly. Due to the fact that the initial intervention is one week before the colonoscopy, additional training sessions will be arranged during this week as needed. The researcher's phone number is also given to the elderly so that they can receive answers to their questions by contacting the researcher. During this time, the researcher will be in link with them by phone and will be consulted if they feel the need. In the final stage, the evaluation is done. In the present study, evaluation will be performed at the beginning of the study and at the end of the intervention (before entering the colonoscopy room) by measuring the level of anxiety by completing the Segal Anxiety Questionnaire, Randomization description: If you receive at least 50% of the total need assessment form, you will be enrolled as a person with an educational need.Then the samples are based on variables such as age, sex, marital status, employment, residence, economic status, insurance, education, home, history of chronic illness (diabetes, hypertension, cancer, copd, etc.), And the matched anxiety score will be assigned to one of the experimental and control groups by random allocation method in both groups, Blinding description: Elderly candidate for colonoscopy Outpatient visit the endoscopy unit of Imam Sajad Hospital in Ramsar. The researcher identifies the elderly candidate for colonoscopy after receiving approval from the University Research Council and obtaining approval from the University Ethics Committee and obtaining permission from the Imam Sajad Hospital in Ramsar, referring to the Endoscopy Unit.Then, by phone call, they will be invited to an introductory meeting and co-operation in a training class at Imam Sajad Hospital in Ramsar a week before colonoscopy. This session will explain the research outline for examples. If they wish and consent to participate in the research and to complete a written consent form, they will be asked to complete a researcher-made form of an elderly candidate for colonoscopy based on the Betty Neuman’s systems model .Individuals will be included in the study if they receive at least 50% of the total form of the needs assessment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>colonoscopy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Patients in the study group received nursing process of Betty Neuman's theory by the researcher plus the routine hospital intervention. Intervention 2: Control group1:  Patients only received the routine hospital 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 potential data can be shared after people have not been identified.

When:
The beginning of the access period to the data files from 1399 for 6 months after the publication of the study results.

To whom:
Study data will only be available to researchers working in academic and scientific institutions.

Conditions:
Any analysis on the data is allowed after obtaining the consent of the researcher.

Where to obtain:
Ways of communication:
Mobile number: 09115757971
ابتداEmail: fatemeh.larijani72@gmail.com

How to obtain:
The respondent first receives an email from the applicant. The respondent is obliged to send the answer within 7-14 days. If the applicant needs to receive information immediately, he can receive the information he needs by contacting the respondent's mobile phone.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Larijani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam sajad hospital-ramsar</address>
        <city>Ramsar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4691151594</zip>
        <telephone>+98 11 5526 7359</telephone>
        <email>fatemeh.larijani72@gmail.com</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Larijani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam sajad hospital-ramsar</address>
        <city>Ramsar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4691151594</zip>
        <telephone>+98 11 5526 7359</telephone>
        <email>fatemeh.larijani72@gmail.com</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Elderly age range of 75-60 years
Willingness to participate in research
Fluency in Persian
Non-use of anti anxiety and anti psychotic drugs
No hearing impairment
No cognitive impairment based on the AMT scale
No record of severe mental crises in the past three months (such as losing close relatives)
No history of endoscopy or colonoscopy
The elderly are merely under a colonoscopy
Obtain at least 50% of Betty Neuman’s systems model Needs Assessment score.</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Non-cooperation of samples at each stage of the study
No referral for colonoscopy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>(K00-K93)</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diseases of the digestive system</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Patients in the study group received nursing process of Betty Neuman's theory by the researcher plus the routine hospital intervention.</i_keyword>
      <i_keyword>Control group1:  Patients only received the routine hospital intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Percent of elderly anxiety level. Timepoint: Elderly anxiety level at the beginning of the study (before the intervention), one hour before the colonoscopy and immediately before entering the colonoscopy room after the intervention. Method of measurement: Segal Anxiety 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>Babol University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-07-21</approval_date>
        <contact_name>Ethics committee of Babol University of Medical Sciences</contact_name>
        <contact_address>Shahid Motahari Ave,  Enghelab Square,  Fatemeh Zahra School of Nursing and Midwifery Ramsar Ramsar Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
