<?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>IRCT20170819035775N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-05-16</date_registration>
      <primary_sponsor>University of social welfare and rehabilitation sciences</primary_sponsor>
      <public_title>effect of  relaxation on anxiety and stress</public_title>
      <acronym></acronym>
      <scientific_title>The effect of  Benson's  relaxation technique  on anxiety and stress before Cesarean delivery in primiparous  women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/26937</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Anxiety. Condition 2: stress.</hc_freetext>
      <i_freetext>Intervention 1: Samples are based on paired and individual dates,in both groups, they will intervene and control.The number of samples was divided into two intervention and control groups includes 60 people which was 30 in the intervention group and 30 people in the control group . Both in the intervention group and in the control group to measure the severity of anxiety and stress of patients at the beginning of hospitalization anxiety and stress questionnaires are given to the patient who are overwhelmed.Then after admission in the intervene group  how to use benson's relaxation method they are taught repeat it at least twice before surgery.In this study, the benson relaxation is as follows the patient is in the best condition in which he feels calm in the bed, closes his eyes, in this case, choose the word that always reminds her of calm  and begin to breathe deeply and regularly and he's done the nose and expelled exhale through the mouth and in every exhale repeats the word in mind. At the same time, the muscles are released from the tip of your toes and this continues to the upper muscles of the body so that all muscles can reach full expansion. The patient maintains this condition for 10 to 20 minutes. Then it is recommended to the patient that avoid changing mode and displacement immediately after the end of the technique. Intervention for each patient twice and every 15 minutes it takes place at intervals of 2 hours.The day of operation in the intervention group again anxiety and stress questionnaires is given to complete the samples half an hour before entering the operating room. Intervention 2: Control group: In the control group, routine care wards will be taken without any additional care by researcher and on behalf of the medical staff which is related to research and without a relaxation technique. In the control group, only the samples which includes 30 people received anxiety and stress questionnaires twice, one time before admission and once upon a day, and they complete half an hour before going to the operating room.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Akram Salmanzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Binjerabadi Alley, Behtashsefat street, Masoodieh</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1787744641</zip>
        <telephone>+98 21 3345 2736</telephone>
        <email>a.salmanzade94@gmail.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Akram Salmanzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Binjerabadi Alley, Behtashsefat Street, Masoodieh</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1787744641</zip>
        <telephone>+98 21 3345 2736</telephone>
        <email>a.salmanzade94@gmail.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Criteria for entering the study: - The originality of the samples - Candidates for cesarean samples - Having reading and writing skills - Full consciousness - Not having a history of psychiatric problems, seizures or epilepsy and severe heart failure approved by the doctor - Desire to attend relaxation sessions</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>The patient's personal desire to not participate in the study from the beginning
Use of sedative and anti-anxiety medications by the patient
The candidate for normal delivery of the patient
Maternal delivery by emergency cesarean section (non-elective)
High-risk pregnancy to confirm doctors</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Samples are based on paired and individual dates,in both groups, they will intervene and control.The number of samples was divided into two intervention and control groups includes 60 people which was 30 in the intervention group and 30 people in the control group . Both in the intervention group and in the control group to measure the severity of anxiety and stress of patients at the beginning of hospitalization anxiety and stress questionnaires are given to the patient who are overwhelmed.Then after admission in the intervene group  how to use benson's relaxation method they are taught repeat it at least twice before surgery.In this study, the benson relaxation is as follows the patient is in the best condition in which he feels calm in the bed, closes his eyes, in this case, choose the word that always reminds her of calm  and begin to breathe deeply and regularly and he's done the nose and expelled exhale through the mouth and in every exhale repeats the word in mind. At the same time, the muscles are released from the tip of your toes and this continues to the upper muscles of the body so that all muscles can reach full expansion. The patient maintains this condition for 10 to 20 minutes. Then it is recommended to the patient that avoid changing mode and displacement immediately after the end of the technique. Intervention for each patient twice and every 15 minutes it takes place at intervals of 2 hours.The day of operation in the intervention group again anxiety and stress questionnaires is given to complete the samples half an hour before entering the operating room.</i_keyword>
      <i_keyword>Control group: In the control group, routine care wards will be taken without any additional care by researcher and on behalf of the medical staff which is related to research and without a relaxation technique. In the control group, only the samples which includes 30 people received anxiety and stress questionnaires twice, one time before admission and once upon a day, and they complete half an hour before going to the operating room.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Stress Score in Kuhn's Perceived Stress Questionnaire. Timepoint: Before the intervention and one day after the intervention. Method of measurement: Using Cohen's Perceived Stress Questionnaire.</prim_outcome>
      <prim_outcome>Anxiety Scale in Spielberger's Clear Anxiety Inventory. Timepoint: Before the intervention and one day after the intervention. Method of measurement: Using Spielberger's Clear 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>University of social welfare and rehabilitation sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-12-22</approval_date>
        <contact_name>ethics committee of University of Social Welfare and Rehabilitation Sciences Tehran</contact_name>
        <contact_address>Childhood stalemate,Student Boulevard, Evin,Tehran Town Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
