<?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>IRCT20241029063544N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-02-11</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of visual relaxation techniques during hemodialysis on the quality of life and happiness of patients referred to the hemodialysis centers of Kerman University of Medical Sciences in Kerman city</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of visual relaxation techniques during hemodialysis on the quality of life and happiness of patients referred to the hemodialysis centers of Kerman University of Medical Sciences in Kerman city</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/80138</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive, Other design features: The characteristics of the participants are completed using a demographic and clinical questionnaire, and then people are randomly assigned to one of the intervention and control groups by a person who is blind to the study.Patients in the control group will receive only the usual care of the dialysis unit, Randomization description: Random block allocation is used to allocate the studied subjects to intervention and control groups. In this method, blocks of 4 are used, in each block two people are in the intervention group and two people are in the control group. R software is used for block random assignment, Blinding description: After collecting the data of both intervention and control groups, without informing the data analyst which data is related to the control group and which data is related to the intervention group, it is given to them to analyze and extract statistics. In fact, the data analyst is blind to which data is related to which group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>The effect of visual relaxation on the quality of life and happiness of hemodialysis patients.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: First, calming images, including images of the sky, forest, and sea, are shown to the patients of the intervention group using LCD or laptop, then the relaxation technique is performed. He shuts up and, concentrating on breathing, takes three deep breaths, filling the lungs with air and emptying it out.After this stage, the patients respectively contract and expand muscles for 14 groups of facial muscles (forehead, eyelids, jaw and lips), neck muscles, fingers and palms, forearms, arms and shoulders, back, back, chest, Abdomen done. , hips, thighs, legs and feet. The contraction of each muscle takes 7-10 seconds and its expansion takes 15-20 seconds. Also, patients should not tighten their muscles during muscle contraction. But the contraction is enough.Finally, ask the patient to imagine a wave of relaxation slowly spreading throughout your body, starting at your feet and continuing slowly through each muscle group to your head and then slowly to your eyes. opens and returns to normal. Intervention 2: Control group: Patients in the control group will receive only the usual care of the dialysis unit.</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 scores related to the quality of life and happiness of the patients will be published in the form of theses and possible articles in the form of a comparison of the scores before and after the intervention after de-identification.

When:
The access period starts 6 months after the results are published

To whom:
Researchers working in scientific and academic institutions and hospital staff

Conditions:
In order to use the non-identifiable data of the study subjects, the requesting individual or group must use the data to conduct research or activities in the field of improving the living conditions of patients and their families and provide documentation related to the mentioned items.

Where to obtain:
09136215820
Rahelemoghbeli.70@gmail.com 
Smnouhi@yahoo.com
09133407727

How to obtain:
You must submit a letter containing confirmation and the reason for your request to use the study data from your respective institution.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Rahele Moghbeli Bahr Asman</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Chamran Blvd., alley 2, plate 1</address>
        <city>Rabor</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7856136737</zip>
        <telephone>+98 34 4245 1626</telephone>
        <email>Rahelemoghbeli.70@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Rahele Moghbeli bahraseman</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Chamran Blvd , Rabuor Town</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7856136737</zip>
        <telephone>+98 34 4245 1626</telephone>
        <email>rahelemoghbeli.70@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1-Having an average age of 18-75 years2-Having a schedule of hemodialysis at least twice a week 3- The patient's ability to communicate with others in order to complete the questionnaire</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>1- Presence of functional disability (skeletal-muscular)2- Suffering from extensive physical and mental diseases affecting the variables of the study, including Alzheimer's, delirium</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>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: First, calming images, including images of the sky, forest, and sea, are shown to the patients of the intervention group using LCD or laptop, then the relaxation technique is performed. He shuts up and, concentrating on breathing, takes three deep breaths, filling the lungs with air and emptying it out.After this stage, the patients respectively contract and expand muscles for 14 groups of facial muscles (forehead, eyelids, jaw and lips), neck muscles, fingers and palms, forearms, arms and shoulders, back, back, chest, Abdomen done. , hips, thighs, legs and feet. The contraction of each muscle takes 7-10 seconds and its expansion takes 15-20 seconds. Also, patients should not tighten their muscles during muscle contraction. But the contraction is enough.Finally, ask the patient to imagine a wave of relaxation slowly spreading throughout your body, starting at your feet and continuing slowly through each muscle group to your head and then slowly to your eyes. opens and returns to normal.</i_keyword>
      <i_keyword>Control group: Patients in the control group will receive only the usual care of the dialysis unit</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life score in the quality of life questionnaire of kidney patients. Timepoint: before the start of the intervention and immediately after the end of the intervention and 1 month after the end of the intervention. Method of measurement: Standard Questionnaire of Quality of Life of Kidney Patients (KDQOL-SF).</prim_outcome>
      <prim_outcome>Happiness score in Oxford Happiness Questionnaire. Timepoint: Before the start of the intervention and immediately after the end of the intervention. Method of measurement: Oxford Happiness Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>In this study, the secondary outcome variable is not measured. Timepoint: -. Method of measurement: -.</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>Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-02-05</approval_date>
        <contact_name>Ethics Committee of Kerman University of Medical Sciences</contact_name>
        <contact_address>Imam Khomeini Hospital, Rabor City, Kerman Province Rabor Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
