<?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>IRCT20251129068151N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-01-26</date_registration>
      <primary_sponsor>Kermanshah University of Medical Sciences</primary_sponsor>
      <public_title>Effect of two methods of Benson relaxation and breathing exercises in preoperative anxiety of patients undergoing hysterectomy.</public_title>
      <acronym></acronym>
      <scientific_title>Comparative study of the effect of two methods of Benson relaxation and breathing exercises in preoperative anxiety of patients undergoing hysterectomy.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-12-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>93</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/87847</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Since this study involves the comparison of three groups, the randomization method will be based on the use of random permuted blocks. To implement this technique, different permutations designated by the letters A, B, and C will be used, utilizing a random sequence generated by the statistical consultant through the website https://www.sealedenvelope.com/. The selected random blocks, prepared by the statistical consultant, will be provided to the study executor. Each block consists of 6 individuals who will be sequentially assigned to the specified groups, Blinding description: This study is single-blind in nature, meaning that the analyst may not know whether the data belong to the control group or the intervention group. During the implementation phase, to reduce the risk of performance bias, the training for breathing exercises and the Benson relaxation technique will be conducted by the principal researcher. However, data collection (anxiety questionnaire) will be performed by another individual who is unaware of the group assignments. In this way, roles are separated, and the likelihood of bias will be minimized.</study_design>
      <phase>N/A</phase>
      <hc_freetext>hysterectomy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group one: Benson relaxation - The Benson relaxation intervention will be performed completely on the patients by the researcher on the patient's bed. First, the intervention will be fully taught to the patient based on the Benson relaxation text. Patients will practice the intervention in the presence of the researcher until they master it, and all the patient's questions will be answered. This intervention will be performed on the patients in two sessions (the night before the operation and the day of the operation before entering the operating room), each time for 20 minutes. Intervention 2: Second intervention group: Breathing exercises - Breathing exercises will be taught to patients individually by the researcher the day before surgery in the patients' hospital room using simple and understandable sentences and face to face. The training will continue until learning occurs. Patients will practice the intervention in the presence of the researcher until they master it. This intervention will be performed on patients in two sessions (the night before surgery and the day of surgery before entering the operating room) for 20 minutes each time. Intervention 3: Control group: No intervention - In this group, no intervention will be performed by the researcher and only routine care will be provided to the patients.</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:
In this study, some of the data can be shared after approval by the main researcher.

When:
Access begins 6 months after results are published.

To whom:
The data will only be available to researchers working in academic and scientific institutions.

Conditions:
The data can be used by researchers working in academic and scientific institutions upon request from the corresponding author.

Where to obtain:
Data are available upon request from the corresponding author via email.

How to obtain:
After the results are published, the requester can request access to the data via email to the corresponding author. The data will be available after approval by the corresponding author.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nasim Hatefi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Central Building of Kermanshah University of Medical Sciences, Shahid Beheshti Blvd., Kermanshah.</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6715847141</zip>
        <telephone>+98 83 3835 8943</telephone>
        <email>nikraveshmahtab1@gmail.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nasim Hatefi moadab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Central Building of Kermanshah University of Medical Sciences, Shahid Beheshti Blvd., Kermanshah.</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6715847141</zip>
        <telephone>+98 83 3835 8943</telephone>
        <email>nasim.hatefi@kums.ac.ir</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Informed and written consent to participate in the study
Patients have Iranian nationality
Patients who do not have  respiratory problems
Patients who do not have speech, hearing, or vision impairments
Patients who do not have prior experience with Benson relaxation techniques or mindfulness
Patients who do not participate in similar research projects</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Not having willing to participate in study
Patients who get psychotherapy treatment</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>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group one: Benson relaxation - The Benson relaxation intervention will be performed completely on the patients by the researcher on the patient's bed. First, the intervention will be fully taught to the patient based on the Benson relaxation text. Patients will practice the intervention in the presence of the researcher until they master it, and all the patient's questions will be answered. This intervention will be performed on the patients in two sessions (the night before the operation and the day of the operation before entering the operating room), each time for 20 minutes.</i_keyword>
      <i_keyword>Second intervention group: Breathing exercises - Breathing exercises will be taught to patients individually by the researcher the day before surgery in the patients' hospital room using simple and understandable sentences and face to face. The training will continue until learning occurs. Patients will practice the intervention in the presence of the researcher until they master it. This intervention will be performed on patients in two sessions (the night before surgery and the day of surgery before entering the operating room) for 20 minutes each time.</i_keyword>
      <i_keyword>Control group: No intervention - In this group, no intervention will be performed by the researcher and only routine care will be provided to the patients.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety levels in all three groups: Benson relaxation, breathing exercises, and routine care. Timepoint: Anxiety measurement before the intervention and one day after the intervention. Method of measurement: Spielberger State-Trait Anxiety Inventory.</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>Kermanshah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-11-01</approval_date>
        <contact_name>Ethics committee of Kermanshah University of Medical Sciences</contact_name>
        <contact_address>Central Building of Kermanshah University of Medical Sciences, Shahid Beheshti Blvd., Kermanshah. Kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
