<?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>IRCT20240211060957N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-02-26</date_registration>
      <primary_sponsor>Shahed University</primary_sponsor>
      <public_title>The Effect of Benson's Relaxation Technique on Anxiety, Depression and Pain in Patients Undergoing Brain Tumor Surgery</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Benson's Relaxation Technique on Anxiety, Depression and Pain in Patients Undergoing Brain Tumor Surgery Admitted to the Intensive Care Unit</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-03-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>74</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/75459</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients are placed in the control or test group by a simple random method through even or odd random numbers placed in a sealed envelope.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Anxiety, Depression, Pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients in the intervention group, in addition to the routine care in the ICU, perform the Benson's Relaxation Technique for 15 minutes in the evening of the day before the operation, one hour before the operation and 24 hours after the operation, under the supervision of the researcher. Benson's Relaxation Technique is taught to the patient as follows: 1- To be placed in a comfortable position in bed. 2- close the eyes slowly. 3- Focus on gradually relaxing the muscles, starting from the soles of the feet and progressing to the face, and keep them relaxed. 4- Inhale through the nose and exhale slowly through the mouth. 5- When he exhales, he should say a pleasant word that calms him down, such as "God" and continue to breathe naturally and easily. 6- Continue these exercises for 15 minutes. 7- After finishing work, sit quietly on the bed for a few minutes with eyes closed and then with eyes open. 8- Do not worry about whether you are successful in achieving a deep level of relaxation or not. Maintain a positive attitude and allow relaxation to occur at its own pace. When intrusive thoughts occur, try to ignore them and return to repeating "God". Intervention 2: Control group: Patients receive routine care in the ICU and no intervention is performed for the control group.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nayereh HABIBI</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>4th flour, No.12, Behzadi Alley, Yas Town, Koohak Avenue, Golestan Town</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1493763885</zip>
        <telephone>+98 21 4475 2664</telephone>
        <email>nayereh.habibi@shahed.ac.ir</email>
        <affiliation>Shahed University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nasrin Alaee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahed University, Opposite Holy Shrine of Imam Khomeini, Khalij Fars Expressway,Tehran, Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>331911865</zip>
        <telephone>+98 21 5121 2130</telephone>
        <email>alaei@shahed.ac.ir</email>
        <affiliation>Shahed University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All brain tumor patients without a history of chemotherapy or radiotherapy who undergo brain tumor surgery for the first time
Having the ability to perform relaxation exercises (not having neurological dysfunction in the form of numbness and immobility of organs)
Full consciousness (score 15 according to the Glasgow Coma Scale)
Not having a tracheal tube
Stable vital signs
Informed and voluntary consent of the patient</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having uncontrolled diabetes
Having a history of anxiety and psychiatric diseases and taking psychiatric and anti-anxiety drugs
Drug addiction</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: Patients in the intervention group, in addition to the routine care in the ICU, perform the Benson's Relaxation Technique for 15 minutes in the evening of the day before the operation, one hour before the operation and 24 hours after the operation, under the supervision of the researcher. Benson's Relaxation Technique is taught to the patient as follows: 1- To be placed in a comfortable position in bed. 2- close the eyes slowly. 3- Focus on gradually relaxing the muscles, starting from the soles of the feet and progressing to the face, and keep them relaxed. 4- Inhale through the nose and exhale slowly through the mouth. 5- When he exhales, he should say a pleasant word that calms him down, such as "God" and continue to breathe naturally and easily. 6- Continue these exercises for 15 minutes. 7- After finishing work, sit quietly on the bed for a few minutes with eyes closed and then with eyes open. 8- Do not worry about whether you are successful in achieving a deep level of relaxation or not. Maintain a positive attitude and allow relaxation to occur at its own pace. When intrusive thoughts occur, try to ignore them and return to repeating "God".</i_keyword>
      <i_keyword>Control group: Patients receive routine care in the ICU and no intervention is performed for the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety score in Hospital Anxiety and Depression Scale. Timepoint: The evening of the day before the operation, half an hour before the operation, 24 hours after the operation. Method of measurement: Hospital Anxiety and Depression Scale.</prim_outcome>
      <prim_outcome>Depression score in Hospital Anxiety and Depression Scale. Timepoint: The evening of the day before the operation, half an hour before the operation, 24 hours after the operation. Method of measurement: Hospital Anxiety and Depression Scale.</prim_outcome>
      <prim_outcome>Pain score on Visual Analog Scale. Timepoint: The evening of the day before the operation, half an hour before the operation, 24 hours after the operation. Method of measurement: Visual Analog Scale.</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>Shahed University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-02-05</approval_date>
        <contact_name>Research Ethics Committees of Shahed University</contact_name>
        <contact_address>Shahed University, facing the holy shrine of Imam Khomeini, Persian Gulf Highway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
