<?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>IRCT20201104049259N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-08-11</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Benson's relaxation technique on anxiety, pain and physiological indicators of bone marrow biopsy candidates</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Benson's relaxation technique on anxiety, pain and physiological indicators of bone marrow biopsy candidates</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-07-27</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/78127</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, patients will be registered based on the determined sample size (80 individuals) and inclusion criteria. They will be assigned to two groups using block randomization By Block Design Website  (a 4-block design will be employed, where two letters A and B are placed in different arrangements within the blocks; a total of 20 blocks will be randomly selected, with each block assigned to groups of four individuals).</study_design>
      <phase>N/A</phase>
      <hc_freetext>bone marrow biopsy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The anxiety questionnaires and physiological index forms were completed before the Benson relaxation technique. Then, in the Benson relaxation intervention group, patients were instructed to perform the Benson relaxation technique as follows: find a comfortable position, slowly close their eyes, and gradually relax all body muscles from their feet to their face. They were advised to maintain their calm, breathe through their nose while being aware of their breath, and exhale slowly through their mouth. As they exhaled, they were to repeat a number or word that evokes a sense of relaxation for them under their breath and breathe normally and comfortably. This process was to be carried out for 20 minutes, with an emphasis on keeping the muscles relaxed. Afterward, they were to open their eyes and remain still for a few minutes. Patients were asked to perform this relaxation technique on the morning of the day of sampling. The levels of anxiety and physiological indicators were measured after the relaxation and before the sampling. Additionally, physiological indicators and pain levels were assessed after the sampling. Intervention 2: Control group: In the control group, only standard care will be provided.</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 There is no more information available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahla Qomi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Blue Wing. School of Nursing. Prophet Muhammad (PBUH) University Complex. Sardasht</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۶۹۴۱-۷-۳۸۴۸۱</zip>
        <telephone>+98 86 3417 3397</telephone>
        <email>Mahlaqomi@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahla Qomi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Blue Wing, School of Nursing, Prophet Muhammad (PBUH) University Complex, Sardasht</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۶۹۴۱-۷-۳۸۴۸۱</zip>
        <telephone>+98 86 3417 3397</telephone>
        <email>Mahlaqomi@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The patient must be a candidate for bone marrow biopsy according to the specialist physician's opinion
Age between 18 and 65 years
Ability to perform muscle relaxation techniques
No physical or mental illnesses that would prevent participation in the study
Moderate to severe anxiety score based on the Spielberger Anxiety Questionnaire
Willingness to participate in the study must be informed and voluntary
No use of sedative or analgesic medications to manage pain and anxiety during the bone marrow biopsy</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Previous experience of bone marrow biopsy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>D75.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Disease of blood and blood-forming organs, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The anxiety questionnaires and physiological index forms were completed before the Benson relaxation technique. Then, in the Benson relaxation intervention group, patients were instructed to perform the Benson relaxation technique as follows: find a comfortable position, slowly close their eyes, and gradually relax all body muscles from their feet to their face. They were advised to maintain their calm, breathe through their nose while being aware of their breath, and exhale slowly through their mouth. As they exhaled, they were to repeat a number or word that evokes a sense of relaxation for them under their breath and breathe normally and comfortably. This process was to be carried out for 20 minutes, with an emphasis on keeping the muscles relaxed. Afterward, they were to open their eyes and remain still for a few minutes. Patients were asked to perform this relaxation technique on the morning of the day of sampling. The levels of anxiety and physiological indicators were measured after the relaxation and before the sampling. Additionally, physiological indicators and pain levels were assessed after the sampling.</i_keyword>
      <i_keyword>Control group: In the control group, only standard care will be provided.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety. Timepoint: Before and after relaxation technique. Method of measurement: State Trait Anxiety Inventory.</prim_outcome>
      <prim_outcome>Physiological indicators. Timepoint: Before the relaxation technique, after the relaxation technique, and after the biopsy. Method of measurement: Physiological indicators form.</prim_outcome>
      <prim_outcome>Pain. Timepoint: after biopsy. 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>Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-06-23</approval_date>
        <contact_name>Ethics Committee of Arak University of Medical Sciences</contact_name>
        <contact_address>Third Floor, Prophet Muhammad (PBUH) University Complex, University of Medical Sciences Arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
