<?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>IRCT20210712051849N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-07-13</date_registration>
      <primary_sponsor>Sabzevar University of Medical Sciences</primary_sponsor>
      <public_title>the effect of benson's relaxation on care burden and coping strategies</public_title>
      <acronym></acronym>
      <scientific_title>Investigation the effect of benson's relaxation on care burden and coping strategies among caregivers of cancer patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-07-18</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>124</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57436</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Samples will be selected by available method and will be placed in intervention and control groups using random allocation permutation blocks. R software will be used to obtain the blocks. In this way, the control group is marked with the letter a and the intervention group with the letter b, and the size of each block is 4 people, the number of blocks is 31 and the number of possible permutations is 6. Then, from the table of random numbers, 31 random numbers are selected. And we fill 31 blocks of scenarios. For example, if block 1 is baba, from the left, the first person will enter the intervention group, the second person will enter the control group, the third person will enter the intervention group, and finally the fourth person will enter the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Benson Relaxation is taught to caregivers as a intervention in a special room in the chemotherapy and radiotherapy wards to fully learn, then a CD is given to them to do  benson relaxation in home twice a day in the morning and evening with at least two hours interval for 20 minutes and continue for four weeks. During the study, three days after the training, the members of the intervention group will be followed up by telephone to ask questions about relaxation and to evaluate stressful events during the study, and it will be repeated every seven days. Then, after four weeks, the care burden questionnaires and coping strategies will be completed again .Benson relaxation is done by asking people to lie down in a quiet environment and in a comfortable position, or to sit on a chair and close their eyes, then slowly relax their muscles from the legs to the face. And at the same time breathe in through the nose and be aware of their breathing, and then say the word "one" silently when exhaling. People are advised not to worry if they do not reach a deep level of relaxation and to allow the relaxation to happen at its own pace, to ignore disturbing thoughts and to focus on saying one exhale at a time. When finished, open your eyes and sit for a few minutes, then stand still (they may open their eyes to check for time while relaxing, without using an alarm). Intervention 2: Control group: The control group will not receive any intervention and will be reviewed solely for the occurrence of stressful events and failure to attend a class or program affecting stress based on the times mentioned above.</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 Information security of participants</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hamid Barghbani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nuclear Martyrs Boulevard, above the Memorial of the Unknown Martyrs, Campus of the University of Medical Sciences, School of Nursing and Midwifery</address>
        <city>Sabzevar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9654135121</zip>
        <telephone>+98 51 4501 3452</telephone>
        <email>hamidbarghbani75@gmail.com</email>
        <affiliation>Sabzevar University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mojgan Ansari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nuclear Martyrs Boulevard, above the Memorial of the Unknown Martyrs, Campus of the University of Medical Sciences, School of Nursing and Midwifery</address>
        <city>Sabzevar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9613873136</zip>
        <telephone>+98 51 4401 8312</telephone>
        <email>mojganansari01@gmail.com</email>
        <affiliation>Sabzevar University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Caring for a cancer patient during the study
Have at least six months of care for a cancer patient
Age of care between 18 to 67 years
Not to be a professional caregiver (not being employed as a health care worker)
Willingness to participate in the study
Have the ability to read and write
Access to the phone to follow the training program
The caregiver obtains the total care pressure score of X≥ 48 based on the score obtained from the questionnaire</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>67 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Neuromuscular disorders
Having an acute illness or special condition that requires medical attention
Severe mental disorder and the use of sedatives
Occurrence of stressful events such as the death of a first-degree relative, separation or divorce, and legal disputes in the past six months and during the course of study
hearing and vision disorders (deaf and dumb)
participate in other research by the caregiver during the last 3 months
receive a fee for care
Participate in any classes or programs that affect stress such as relaxation, yoga and meditation</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C80.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm, without specification of site</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: Benson Relaxation is taught to caregivers as a intervention in a special room in the chemotherapy and radiotherapy wards to fully learn, then a CD is given to them to do  benson relaxation in home twice a day in the morning and evening with at least two hours interval for 20 minutes and continue for four weeks. During the study, three days after the training, the members of the intervention group will be followed up by telephone to ask questions about relaxation and to evaluate stressful events during the study, and it will be repeated every seven days. Then, after four weeks, the care burden questionnaires and coping strategies will be completed again .Benson relaxation is done by asking people to lie down in a quiet environment and in a comfortable position, or to sit on a chair and close their eyes, then slowly relax their muscles from the legs to the face. And at the same time breathe in through the nose and be aware of their breathing, and then say the word "one" silently when exhaling. People are advised not to worry if they do not reach a deep level of relaxation and to allow the relaxation to happen at its own pace, to ignore disturbing thoughts and to focus on saying one exhale at a time. When finished, open your eyes and sit for a few minutes, then stand still (they may open their eyes to check for time while relaxing, without using an alarm).</i_keyword>
      <i_keyword>Control group: The control group will not receive any intervention and will be reviewed solely for the occurrence of stressful events and failure to attend a class or program affecting stress based on the times mentioned above.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Care burden of caregivers. Timepoint: Before and four weeks after the intervention. Method of measurement: Novak and Guest Caregiver burden Questionnaire.</prim_outcome>
      <prim_outcome>Caregiver coping strategies. Timepoint: Before and four weeks after the intervention. Method of measurement: Endler and Parker Short Form Coping 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>Sabzevar University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-05-10</approval_date>
        <contact_name>Research Ethics Committee of Sabzevar University of Medical Sciences</contact_name>
        <contact_address>Nuclear Martyrs Boulevard, above the Memorial of the Unknown Martyrs, Campus of the University of Medical Sciences, Vice Chancellor for Research and Technology Sabzevar Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
