<?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>IRCT20250715066498N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-09-14</date_registration>
      <primary_sponsor>Shahid Rajaei Cardiovascular Medical, Research, and Educational Center</primary_sponsor>
      <public_title>Comparison of guided imagery and diaphragmatic breathing on anxiety</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of guided imagery with diaphragmatic breathing on anxiety in patients scheduled for coronary angiography</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/84979</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The block randomization method with blocks of size three was applied, with a total sample size of 30 participants in each of the three groups (Diaphragmatic Breathing [A], Guided Imagery [B], and Control [C]), resulting in 90 participants overall. A total of 30 blocks of three participants each were used. Within each block, the three participants were randomly assigned to the three groups so that each group received exactly one participant per block. The possible allocations for each block were the six permutations: (A, B, C), (A, C, B), (B, A, C), (B, C, A), (C, A, B), and (C, B, A). One of these permutations was then randomly selected using a random number table.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patients who are candidates for coronary angiography.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: The diaphragmatic breathing group, one hour prior to angiography, after obtaining informed consent, completing the demographic questionnaire and the HADS anxiety questionnaire, and measuring heart rate and blood pressure, will listen for approximately 20 minutes to an audio file containing the psychologist's guided instructions, soothing music, and step-by-step diaphragmatic breathing training. After the intervention, the anxiety questionnaire will be completed again, and heart rate and blood pressure will be re-measured. Intervention 2: Intervention group 2: The guided imagery group, one hour prior to angiography, after obtaining informed consent, completing the demographic questionnaire and the HADS anxiety questionnaire, and measuring heart rate and blood pressure, will listen for approximately 20 minutes to an audio file containing the psychologist’s guided instructions, soothing music, and step-by-step guided imagery training. Following the intervention, the anxiety questionnaire will be completed again, and heart rate and blood pressure will be re-measured. Intervention 3: Control group: The control group, one hour prior to angiography, after obtaining informed consent, completing the demographic questionnaire and the HADS anxiety questionnaire, and measuring heart rate and blood pressure, will receive routine care. Following the routine care, the anxiety questionnaire, heart rate, and blood pressure will be measured again.</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 To ensure the confidentiality of patient information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zeynab Khorshidi Nikbin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Rajaei Cardiovascular Medical, Research, and Educational Center Corner of Niayesh and Vali Asr (A.S.) Street, Next to Mellat Park, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1995614331</zip>
        <telephone>+98 21 23921</telephone>
        <email>khbehnaz1996@gmail.com</email>
        <affiliation>Shahid Rajaei Cardiovascular Medical, Research, and Educational Center</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zeynab Khorshidi Nikbin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Rajaei Cardiovascular Medical, Research, and Educational Center Corner of Niayesh and Vali Asr (A.S.) Street, Next to Mellat Park, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1995614331</zip>
        <telephone>+98 21 23921</telephone>
        <email>khbehnaz1996@gmail.com</email>
        <affiliation>Shahid Rajaei Cardiovascular Medical, Research, and Educational Center</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age over 18 years
Willingness to cooperate
Full alertness
Literacy in reading and writing
Candidate for coronary angiography</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Hearing problem
Use of anti-anxiety medications in the past 6 months
History of psychiatric illness
Substance addiction
Use of stress reduction methods before the start of this study
Patients with moderate to severe anxiety</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>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: The diaphragmatic breathing group, one hour prior to angiography, after obtaining informed consent, completing the demographic questionnaire and the HADS anxiety questionnaire, and measuring heart rate and blood pressure, will listen for approximately 20 minutes to an audio file containing the psychologist's guided instructions, soothing music, and step-by-step diaphragmatic breathing training. After the intervention, the anxiety questionnaire will be completed again, and heart rate and blood pressure will be re-measured.</i_keyword>
      <i_keyword>Intervention group 2: The guided imagery group, one hour prior to angiography, after obtaining informed consent, completing the demographic questionnaire and the HADS anxiety questionnaire, and measuring heart rate and blood pressure, will listen for approximately 20 minutes to an audio file containing the psychologist’s guided instructions, soothing music, and step-by-step guided imagery training. Following the intervention, the anxiety questionnaire will be completed again, and heart rate and blood pressure will be re-measured.</i_keyword>
      <i_keyword>Control group: The control group, one hour prior to angiography, after obtaining informed consent, completing the demographic questionnaire and the HADS anxiety questionnaire, and measuring heart rate and blood pressure, will receive routine care. Following the routine care, the anxiety questionnaire, heart rate, and blood pressure will be measured again.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety. Timepoint: Anxiety is measured before and after the intervention of diaphragmatic breathing and guided imagery. It is also measured before and after routine care in the control group. Method of measurement: Anxiety is evaluated through the Hospital Anxiety and Depression Scale (HADS) questionnaire.</prim_outcome>
      <prim_outcome>Blood pressure measurement. Timepoint: Blood pressure will be measured before and after the interventions of diaphragmatic breathing and guided imagery. It will also be measured before and after routine care in the control group. Method of measurement: using manual blood pressure monitor.</prim_outcome>
      <prim_outcome>Heart rate. Timepoint: Heart rate will be measured before and after the interventions of diaphragmatic breathing and guided imagery. It will also be measured before and after routine care in the control group. Method of measurement: Pulse oximeter.</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>Shahid Rajaei Cardiovascular Medical, Research, and Educational Center</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-07-07</approval_date>
        <contact_name>The Ethics Committee of Shahid Rajaei Cardiovascular Medical and Research Center</contact_name>
        <contact_address>Ministry of Health and Medical Education, Central Headquarters, Block A, 13th Floor, Simaye Iran St., Shahrak-e Gharb (Qods), Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
