<?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>IRCT20141109019862N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-04-20</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of abdominal massage with and without Salvia officinalis aromatic substance on nausea, vomiting, and constipation of patients undergoing chemotherapy</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of abdominal massage with and without Salvia officinalis aromatic substance on nausea, vomiting, and constipation of patients undergoing chemotherapy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>75</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/37770</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Samples (75 people) will select by convenience  sampling method .Then randomly will be allocated blocks into three groups;2 intervention groups (25 massage with salvia officinalis , 25 non-aromatic massage) and 25 in the control group. In this method, random block allocation will perform by the software.</study_design>
      <phase>N/A</phase>
      <hc_freetext>neoplasm.</hc_freetext>
      <i_freetext>Intervention 1: Control group: In this group for the control of nausea, vomiting and constipation are the drugs prescribed by the doctor digestive and laxative use and there is no intervention. Intervention 2: Intervention group: In this group, in addition to routine care only of abdominal massage without aromatic material will be used. Before the massage,  patient privacy is maintained. How do massage is the massage for half an hour on an empty stomach before feeding is done for patient comfort. The patient is placed in the back rest so that the legs bend from the knees slightly and the head is at a angle of 15 to 30 degrees. Coverage of the massage area is removed from the upper anterior lobe of the iliac buccal underneath the lower chest ribs and the rest of the body is covered. Then the massage therapist, who is a member of the patient family, is on the right and facing the lower level of the patient's pelvis. Massage begins. It should be noted that accompanying the patient after examination of the patient's stomach in terms of mass and other prohibitions of massage, in the absence of a problem, massage begins. Massage in a clockwise direction and start from scratch ascending colon, the colon and the descending colon landscape and finally to the end of the massage continues. Massage in Swedish massage style involves stroking or stroking, eyelinating, or gyrotic, vibration or vibration and hand massage or nidding 2 times a day for 15 minutes at 8:30 and 20:30. Massage time  is set to take place at fixed intervals and not interfere with the patient's sleep. Intervention 3: 2 Intervention group: In this group, in addition to routine care abdominal massage with salvia officinalis  will be used. How to do an intervention in a massage group with a scented substance is exactly the same as a massaging group without aromatic matter, with the difference that in this method of use  2 cc the salvia officinalis  (making barij Kashan essential oil) at each massage time for abdominal massage will be.</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:
As an original article

When:
After publish as an article in a journal

To whom:
Public

Conditions:
For undergoing chemotherapy patients and research fields

Where to obtain:
Published documents

How to obtain:
Via email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Sakineh Sabzevari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Haft Bagh Blvd</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>76177</zip>
        <telephone>+98 34 3132 5219</telephone>
        <email>S_Sabzevari@kmu.ac.ir</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Sakineh sabzevari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Haft Bagh Blvd</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>76177</zip>
        <telephone>+98 34 3132 5219</telephone>
        <email>S_Sabzevari@kmu.ac.ir</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age over 18 years
Constipation Assessment Score of eight or higher</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Coagulation disorders
History of migraine and chronic headache
History of allergy to herbs
Meniere's syndrome
Respiratory problems
Sensitivity to aromatic substances
History of respiratory disease such as asthma, rhinitis, sinus disorders
Use aromatherapy for patients one week before intervention</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>N/A</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: In this group for the control of nausea, vomiting and constipation are the drugs prescribed by the doctor digestive and laxative use and there is no intervention.</i_keyword>
      <i_keyword>Intervention group: In this group, in addition to routine care only of abdominal massage without aromatic material will be used. Before the massage,  patient privacy is maintained. How do massage is the massage for half an hour on an empty stomach before feeding is done for patient comfort. The patient is placed in the back rest so that the legs bend from the knees slightly and the head is at a angle of 15 to 30 degrees. Coverage of the massage area is removed from the upper anterior lobe of the iliac buccal underneath the lower chest ribs and the rest of the body is covered. Then the massage therapist, who is a member of the patient family, is on the right and facing the lower level of the patient's pelvis. Massage begins. It should be noted that accompanying the patient after examination of the patient's stomach in terms of mass and other prohibitions of massage, in the absence of a problem, massage begins. Massage in a clockwise direction and start from scratch ascending colon, the colon and the descending colon landscape and finally to the end of the massage continues. Massage in Swedish massage style involves stroking or stroking, eyelinating, or gyrotic, vibration or vibration and hand massage or nidding 2 times a day for 15 minutes at 8:30 and 20:30. Massage time  is set to take place at fixed intervals and not interfere with the patient's sleep.</i_keyword>
      <i_keyword>2 Intervention group: In this group, in addition to routine care abdominal massage with salvia officinalis  will be used. How to do an intervention in a massage group with a scented substance is exactly the same as a massaging group without aromatic matter, with the difference that in this method of use  2 cc the salvia officinalis  (making barij Kashan essential oil) at each massage time for abdominal massage will be.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Nausea, vomiting and constipation. Timepoint: Before intervention, immediately after abdominal massage, and a week after abdominal massage. Method of measurement: The instrument will be a questionnaire consisting of three parts; demographic  information, Constipation Assessment Scale and Visual Analog Scale for  nausea and vomiting.</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>Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-02-18</approval_date>
        <contact_name>Ethical committee of Kerman University of Medical Sciences</contact_name>
        <contact_address>Jahad Blvd, Ebn Sina avenue kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
