<?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>IRCT20190126042498N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-04-20</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of peer support on hope, acceptance of disability and social relational quality in patients undergoing hemodialysis</public_title>
      <acronym></acronym>
      <scientific_title>The effect of peer support on hope, acceptance of disability and social relational quality in patients undergoing hemodialysis referred to hemodialysis centers affiliated to Shiraz University of Medical Sciences 2018-2019.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-05-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>128</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/37168</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: After receiving the approval of the Ethics Committee of Shiraz University of Medical Sciences, the list of the research community is prepared according to the list of patients with active records in the selected hemodialysis centers of Shiraz University of Medical Sciences. Patients are randomly selected using random numbers tables. Then, to enter the groups, the days of the week are divided into two groups based on the random throwing of the coin. Accordingly, the patients were randomly assigned to one of the two control and intervention groups based on the pair and weekly days, Blinding description: On the one hand, the blindness of the study will be used to collect the data and complete the questionnaires with the help of a researcher who is not aware of the division of the groups. Also, a statistics specialist who performs data analysis will be blind to groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic renal failure.patients undergoing hemodialysis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the intervention group, in order to select the peer group, a list of hemodialysis patients from the selected hemodialysis centers of Shiraz University of Medical Sciences will be prepared and targeted and selected from among them who have the following conditions: willing to volunteer for participation In the study, they should be hemodialized for at least 6 months, have a good faculty, have the ability to organize sessions and have an interest in the leadership of the group, have a good relationship, are interested in education, are educated and willing to teach, while in the opinion of the expert physician Kidney and general practitioner of hemodialysis centers based on the evidence in the case, such as: Results of all tests and examinations, periodic medical and other specialists from complications of hemodialysis, the successful management of their disease. These criteria are based on the checklist according to the review of the texts and the standard terms of reference of the peer and according to the opinion of the professors. Finally, in order to provide peer support, 10 peers will be selected, who will be trained by the researcher during 3 two-hour training sessions. The first session focuses on the implications, the importance and benefits of peer support, the correct communication skills and how to provide tangible and peer support to the peer, and the second session on how to provide information support to peers (such as the necessary preparations and care before and after hemodialysis and activity At home and preventing the physical and psychiatric side effects of the disease). The third session also describes how psychosocial support is provided to peers as well as the peace of mind. Further questions are answered by their counterparts and their beliefs are corrected on the basis of scientific sources. At the end of each session, Given is discussed. The method of teaching a researcher will be lecture, question and answer, and use of whiteboard. After each training session, the peer group will practice their training and support as a way of acting in the presence of the researcher. Subsequently, in order to ensure the readiness of the peers and to harmonize their education, the researcher will examine how the peers will be supported, according to the checklist prepared according to the items expressed in the three sessions. In the following, a booklet of all the materials presented in the meetings is provided to their counterparts. After preparing the group of peers, the patients, according to the pair or person to visit, were randomly selected using coin tossing in two groups Control and intervention. The systematic random method will then be used to identify individuals to enter the groups. The control group will receive routine hemodialysis treatment. In the intervention group, the sessions will be held once a week for 2 hours for 8 weeks for each of the groups before the onset of hemodialysis. For each group, the peer will be selected randomly and by gender. The peer group will train and support your group face to face with group discussion, question and answer, and troubleshooting issues. People from the group who are absent from 2 or less than 2 sessions will receive the topics discussed at the meeting by telephone from the researcher or peer group. The method of formation and management of the support group will be the same in all three groups and the issues of conscientiousness and culture will be observed during the sessions. At the first session, patients' health problems will be asked and then, according to priority, the subjects in each group, separately for the next seven sessions of the program It will be customized. Topics include the provision of various types of social support (psychological, emotional, informational, tangible and social support) by the peer group, changes in physical and psychological complications such as muscle cramps, problems with sleep and itching, proper nutrition and sexual problems. At each session, when discussing a disorder, approaches to adapt to changes and problems, to adapt to the state of being and to construct a new concept of life, to emphasize the use of experiences and opinions of others. Teaching slowly, teaching about disease and practices Controlling it, clarifying values, teaching thinking and self-management of emotions, and planning pleasure-pleasing activities are also discussed at these meetings. The titles of the sessions are almost the same in all three groups. In group of peers, the researcher is a facilitator, which leads to the effectiveness of the group. The researcher is responsible for facilitating group discussion, providing accurate scientific information, focusing on the group's dynamic process (lack of a person's control over the discussion, encouraging all members to discuss and solve the problem, facilitating members' communications, etc.), providing feedback to members, and paying attention to Law enforcement in the group. To prevent leakage of information, control and intervention groups are placed in separate shifts for dialysis to not meet each other. Before and immediately after the end of the sessions, data are collected using a questionnaire. Intervention 2: Control group: Patients in both control and intervention groups will receive routine hemodialysis care.</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:
The following ethical considerations are considered in the implementation of the plan:
- The principles of Helsinki in all stages of the study.
- The principle of anonymity regarding questionnaires and their encoding.
-Thank your permission from the relevant authorities at the college, university, and hospital.
-Increase keeping participants' information and encoding questionnaires.
- Understand the goals of the study and obtain informed consent from all participants.
-Free freely from study in case of reluctance to cooperate.
-Research results will be made available to participants and relevant organizations upon request.

When:
After the end of the study

To whom:
Research results will be made available to participants and relevant organizations upon request.

Conditions:
The principle of anonymity regarding questionnaires and their encoding.
-Thank your permission from the relevant authorities at the college, university, and hospital.
-Increase keeping participants' information and encoding questionnaires

Where to obtain:
Zand Street, Shiraz, Library of Shiraz Nursing and Midwifery Faculty. Mr. Qasemi Library Dept. Telephone: 00987136474254

How to obtain:
The request for data is sent to the library of the Nursing and Midwifery Faculty of Shiraz. The coordination is done after one week of data being sent to them.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nilofar Pasyar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.342, Behesht Ave.Tachara</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71345-1978</zip>
        <telephone>+98 71 3647 4254</telephone>
        <email>Npasyar@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nilofar Pasyar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.342, Behesht Ave.Tachara</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71345-1978</zip>
        <telephone>+98 71 3647 4254</telephone>
        <email>Npasyar@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1.The age of the patients is between the ages of 18 and 60 years.
2.At least 6 months should be treated with hemodialysis.
3.Hemodializes at least 2 times a week and up to 3 times a week.
4.Willing to participate in the study.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>1. The patient has advanced cardiovascular disease, such as heart failure and acute pulmonary edema.
2.The patient has sensory-neurological disorders such as hearing impairment and vision or cognitive impairment such as dementia.
3.The patient has drug addiction.
4. Patient faced with emotional crisis such as close relatives and divorce during the past 6 months.
5. Patients who are not willing to continue to work.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N18.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic kidney disease, stage 5</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the intervention group, in order to select the peer group, a list of hemodialysis patients from the selected hemodialysis centers of Shiraz University of Medical Sciences will be prepared and targeted and selected from among them who have the following conditions: willing to volunteer for participation In the study, they should be hemodialized for at least 6 months, have a good faculty, have the ability to organize sessions and have an interest in the leadership of the group, have a good relationship, are interested in education, are educated and willing to teach, while in the opinion of the expert physician Kidney and general practitioner of hemodialysis centers based on the evidence in the case, such as: Results of all tests and examinations, periodic medical and other specialists from complications of hemodialysis, the successful management of their disease. These criteria are based on the checklist according to the review of the texts and the standard terms of reference of the peer and according to the opinion of the professors. Finally, in order to provide peer support, 10 peers will be selected, who will be trained by the researcher during 3 two-hour training sessions. The first session focuses on the implications, the importance and benefits of peer support, the correct communication skills and how to provide tangible and peer support to the peer, and the second session on how to provide information support to peers (such as the necessary preparations and care before and after hemodialysis and activity At home and preventing the physical and psychiatric side effects of the disease). The third session also describes how psychosocial support is provided to peers as well as the peace of mind. Further questions are answered by their counterparts and their beliefs are corrected on the basis of scientific sources. At the end of each session, Given is discussed. The method of teaching a researcher will be lecture, question and answer, and use of whiteboard. After each training session, the peer group will practice their training and support as a way of acting in the presence of the researcher. Subsequently, in order to ensure the readiness of the peers and to harmonize their education, the researcher will examine how the peers will be supported, according to the checklist prepared according to the items expressed in the three sessions. In the following, a booklet of all the materials presented in the meetings is provided to their counterparts. After preparing the group of peers, the patients, according to the pair or person to visit, were randomly selected using coin tossing in two groups Control and intervention. The systematic random method will then be used to identify individuals to enter the groups. The control group will receive routine hemodialysis treatment. In the intervention group, the sessions will be held once a week for 2 hours for 8 weeks for each of the groups before the onset of hemodialysis. For each group, the peer will be selected randomly and by gender. The peer group will train and support your group face to face with group discussion, question and answer, and troubleshooting issues. People from the group who are absent from 2 or less than 2 sessions will receive the topics discussed at the meeting by telephone from the researcher or peer group. The method of formation and management of the support group will be the same in all three groups and the issues of conscientiousness and culture will be observed during the sessions. At the first session, patients' health problems will be asked and then, according to priority, the subjects in each group, separately for the next seven sessions of the program It will be customized. Topics include the provision of various types of social support (psychological, emotional, informational, tangible and social support) by the peer group, changes in physical and psychological complications such as muscle cramps, problems with sleep and itching, proper nutrition and sexual problems. At each session, when discussing a disorder, approaches to adapt to changes and problems, to adapt to the state of being and to construct a new concept of life, to emphasize the use of experiences and opinions of others. Teaching slowly, teaching about disease and practices Controlling it, clarifying values, teaching thinking and self-management of emotions, and planning pleasure-pleasing activities are also discussed at these meetings. The titles of the sessions are almost the same in all three groups. In group of peers, the researcher is a facilitator, which leads to the effectiveness of the group. The researcher is responsible for facilitating group discussion, providing accurate scientific information, focusing on the group's dynamic process (lack of a person's control over the discussion, encouraging all members to discuss and solve the problem, facilitating members' communications, etc.), providing feedback to members, and paying attention to Law enforcement in the group. To prevent leakage of information, control and intervention groups are placed in separate shifts for dialysis to not meet each other. Before and immediately after the end of the sessions, data are collected using a questionnaire.</i_keyword>
      <i_keyword>Control group: Patients in both control and intervention groups will receive routine hemodialysis care</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Hope score in Snyder questionnaire. Timepoint: At the beginning of the study and two months after the onset of peer support for hemodialysis patients. Method of measurement: Hope Snyder questionnaire.</prim_outcome>
      <prim_outcome>Acceptance of disability score in acceptance of disability questionnaire. Timepoint: At the beginning of the study and two months after the onset of peer. Method of measurement: Acceptance of disability questionnaire.</prim_outcome>
      <prim_outcome>Social relational quality score in social relational quality questionnaire. Timepoint: At the beginning of the study and two months after the onset of peer. Method of measurement: Social relational quality 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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-02-05</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Fars Province University of Medical Sciences and Health Services, Zand Avenue Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
