<?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>IRCT20181122041720N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-12-06</date_registration>
      <primary_sponsor>Research Deputy of Shahrekord University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the Effect of Progressive Muscle Relaxation Technique and Aromatherapy with Damask Rose on Anxiety, Stress and Depression in General Surgical Candidates</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effect of Progressive Muscle Relaxation Technique and Aromatherapy with Damask Rose on Anxiety, Stress and Depression in General Surgical Candidates</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-12-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35422</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: After entering the study, the participants were randomly assigned to three groups using computer software using three blocks. To hide the assignment, the type of intervention was determined based on the blocking on the paper and placed inside the opaque packs of the sequential numbering. Envelopes were opened in the order of participation of the participants, and the specified intervention was implemented for the participants.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Hernia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group: In the progressive muscle relaxant group, the questionnaire was completed by the researcher and the patient's vital signs were recorded by the researcher and recorded in the form. The intervention is done so that on the day of the work of the researcher, referring to the general surgery department of Kashani Hospital in Shahrekord, and reviewing the surgical list, select the samples and transferring the patient to the place intended for training progressive muscle relaxation, He teaches every person face-to-face and practical relaxation. Then, one hour before the patient goes to the operating room, by providing a completely quiet environment and minimizing environmental stimuli, such as low light of the room, and limiting travel to the patient's room, the patient through the hands-free program of progressive muscle relaxation audio in the presence of The researcher listens.In this method, the patient is placed in a comfortable comfortable bed. Closes his eyes and, as far as possible, stays in a state of relaxation and concentrates all his attention on his breathing. 5 times deep breath and each time the lungs completely fill the air and gently empty. Meanwhile, in his mind, he thinks relaxed and relaxed. After this stage, the patient should have muscle contraction and expansion for 14 muscle groups, including facial muscles (forehead, eyelids, jaws and lips), neck muscles, fingers and palms, forearm, arm, shoulder, back, Lumbar, chest, abdomen, seat, thighs, legs and legs. Each muscle contraction is 5 seconds and its expansion lasts 10 seconds. During the procedure, the patient should focus on the muscles that rigidify and relax. At the end, the patient relaxes his entire body, breathes deeply and lets his eyes slowly open and return to normal. The patient does this technique for 20 minutes (1). Then, the DASS questionnaire and the vital signs registration form are completed by the researcher.In the scent group, the questionnaires are first completed by the researcher and the patient's vital signs are recorded by the researcher and recorded in the relevant form. The intervention is then done on the day of operation one hour before going to the operating room, three drops of 10% essential oil from the flower of Mohammadi (made in Barij Essen, Kashan) will be poured onto a tissue paper and pinned on the pillow of the patients. And patients are asked to smell it for 20 minutes. According to previous studies, a tissue paper impregnated with three drops of essential oil of 10% may be produced for 12 hours (8 and 1). After the intervention, the DASS questionnaire and the vital signs registration form are completed by the researcher.Sampling in groups is done simultaneously. Intervention 2: Control group: Control group: There is no intervention in the control group and all routine nursing care before the operation includes the patient's NPO, the location of the operation and the completion of the patient's case. In this group, the questionnaires were completed only one hour prior to going to the operating room and vital signs are recorded.</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 No more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shirin Madadkar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing Street, Kashani Hospital</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8816758915</zip>
        <telephone>+98 38 3226 4825</telephone>
        <email>Shirinmadadkar@gmail.com</email>
        <affiliation>Shahre-kord University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shirin Madadkar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing Street, Kashani Hospital</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8816758915</zip>
        <telephone>+98 38 3226 4825</telephone>
        <email>shirinmadadkar@gmail.com</email>
        <affiliation>Shahre-kord University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1. The patient is on the list of elective general surgery (hernia and cholecystectomy).
2- Having at least 18 and up to 60 years old.
3- No history of surgery.
4- The desire to cooperate in research
5- Hospitalization in the surgery part of the day before surgery</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>1. Acute pain at the time of completing the questionnaire
2. Use of benzodiazepines and tranquillizers and opiates
3. History of allergy to plants
4. Death of the sick</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K40</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Inguinal hernia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: In the progressive muscle relaxant group, the questionnaire was completed by the researcher and the patient's vital signs were recorded by the researcher and recorded in the form. The intervention is done so that on the day of the work of the researcher, referring to the general surgery department of Kashani Hospital in Shahrekord, and reviewing the surgical list, select the samples and transferring the patient to the place intended for training progressive muscle relaxation, He teaches every person face-to-face and practical relaxation. Then, one hour before the patient goes to the operating room, by providing a completely quiet environment and minimizing environmental stimuli, such as low light of the room, and limiting travel to the patient's room, the patient through the hands-free program of progressive muscle relaxation audio in the presence of The researcher listens.In this method, the patient is placed in a comfortable comfortable bed. Closes his eyes and, as far as possible, stays in a state of relaxation and concentrates all his attention on his breathing. 5 times deep breath and each time the lungs completely fill the air and gently empty. Meanwhile, in his mind, he thinks relaxed and relaxed. After this stage, the patient should have muscle contraction and expansion for 14 muscle groups, including facial muscles (forehead, eyelids, jaws and lips), neck muscles, fingers and palms, forearm, arm, shoulder, back, Lumbar, chest, abdomen, seat, thighs, legs and legs. Each muscle contraction is 5 seconds and its expansion lasts 10 seconds. During the procedure, the patient should focus on the muscles that rigidify and relax. At the end, the patient relaxes his entire body, breathes deeply and lets his eyes slowly open and return to normal. The patient does this technique for 20 minutes (1). Then, the DASS questionnaire and the vital signs registration form are completed by the researcher.In the scent group, the questionnaires are first completed by the researcher and the patient's vital signs are recorded by the researcher and recorded in the relevant form. The intervention is then done on the day of operation one hour before going to the operating room, three drops of 10% essential oil from the flower of Mohammadi (made in Barij Essen, Kashan) will be poured onto a tissue paper and pinned on the pillow of the patients. And patients are asked to smell it for 20 minutes. According to previous studies, a tissue paper impregnated with three drops of essential oil of 10% may be produced for 12 hours (8 and 1). After the intervention, the DASS questionnaire and the vital signs registration form are completed by the researcher.Sampling in groups is done simultaneously.</i_keyword>
      <i_keyword>Control group: Control group: There is no intervention in the control group and all routine nursing care before the operation includes the patient's NPO, the location of the operation and the completion of the patient's case. In this group, the questionnaires were completed only one hour prior to going to the operating room and vital signs are recorded</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Depression. Timepoint: Before intervention and immediately after intervention. Method of measurement: DASS questionnaire.</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: Before intervention and immediately after intervention. Method of measurement: DASS questionnaire.</prim_outcome>
      <prim_outcome>Stress. Timepoint: Before intervention and immediately after intervention. Method of measurement: DASS questionnaire.</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>Research Deputy of Shahrekord University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-03-02</approval_date>
        <contact_name>Ethics Committee of Shahrekord University of Medical Sciences</contact_name>
        <contact_address>Rahmatieh Shahrekord University of Medical Sciences Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
