<?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>IRCT20250514065728N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-06-09</date_registration>
      <primary_sponsor>Zabol University of Medical Sciences</primary_sponsor>
      <public_title>Investigating abdominal exercises with and without mint extract on the residual volume of the stomach and abdominal distension in patients undergoing enteral nutrition treatment admitted to the intensive care unit</public_title>
      <acronym></acronym>
      <scientific_title>Investigating abdominal exercises with and without mint extract on the residual volume of the stomach and abdominal distension in patients undergoing enteral nutrition treatment admitted to the intensive care unit</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>25</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/83532</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: To allocate participants to the intervention and control groups, a block randomization method with a block size of 6 and equal allocation (1:1:1) will be used. Randomization will be generated using Random Allocation Generator software, and group allocation will be done in a secret manner and by random coding, Blinding description: Participants are not aware of the massage with mint extract and the massage without mint extract, and they are only explained how to perform the massage and why it is performed.</study_design>
      <phase>N/A</phase>
      <hc_freetext>constipation.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Abdominal massage with mint extract In this group, patients admitted to the ICU who are receiving enteral nutrition will receive abdominal massage twice daily. The massage will be performed by a trained nurse for 15 minutes each time using 5% mint extract. The massage will be performed in a circular, clockwise motion and will include the four quadrants of the abdomen. The mint extract used is manufactured by Gol Daru Company and will be used as a topical solution diluted with sweet almond oil in a 1:1 ratio. This intervention will be performed for 3 consecutive days. Intervention 2: Intervention Group 2: Abdominal Massage Without Peppermint Extract In this group, patients will receive abdominal massage twice daily for 15 minutes, similar to intervention group 1, but without the use of peppermint extract. The massage will be performed with a base oil (sweet almond oil), and the massage technique and location will be the same as in the first group. This intervention will also be performed for 3 consecutive days. Intervention 3: Control group: : : No abdominal massage In this group, patients will receive only routine nursing care and common enteral feeding protocols in the ICU, without any additional interventions including massage or the use of topical agents.</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:
All data in this trial can be published after participants are de-identified.

When:
6 months after publication of the product

To whom:
Everyone interested in the field of research

Conditions:
In case of positive research results

Where to obtain:
IranDoc thesis site

How to obtain:
No special process is required, just search in IranDoc browser

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Marziyeh Safari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Block13 and14, Kohestan complex, North ISsargaran street, Book squere, Saadat abad, Tehran, IRan</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1981773433</zip>
        <telephone>+98 21 2209 0220</telephone>
        <email>mss.safari82@gmail.com</email>
        <affiliation>Zabol University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Marziyeh Safari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Block13 and14, Kohestan complex, North ISsargaran street, Book squere, Saadat abad, Tehran, IRan</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1981773433</zip>
        <telephone>+98 21 2209 0220</telephone>
        <email>mss.safari82@gmail.com</email>
        <affiliation>Zabol University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 18-65 years
Patients admitted to a special ward with enteral nutrition
Maximum 3 times since the start of enteral nutrition
No receipt of metoclopramide, cisapride, anticholinergic drugs.
No history of radiotherapy and abdominal surgery in the last 6 weeks (due to wounds and damaged tissues in the abdominal area, it may cause problems for the patient due to rupture, infection, etc. due to massage)
- Level of consciousness ≤7.
No contraindications to massage such as: cellulitis, abdominal mass, peritonitis, abdominal aneurysm, ascites, diverticulitis, possibility of any thromboembolism in the last year, presence and history of DVT in the last year
Similar reason for hospitalization such as brain injuries, hospitalization in the neurosurgical intensive care unit.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having more than two consecutive bouts of vomiting (less than 12 hours)
Taking metoclopramide for vomiting
Being NPO due to a lab test or surgical procedure lasting more than 12 hours
Diarrhea more than 3 times a day
Transferring the patient to the ward in less than 3 days</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K59.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Functional intestinal disorder, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Abdominal massage with mint extract In this group, patients admitted to the ICU who are receiving enteral nutrition will receive abdominal massage twice daily. The massage will be performed by a trained nurse for 15 minutes each time using 5% mint extract. The massage will be performed in a circular, clockwise motion and will include the four quadrants of the abdomen. The mint extract used is manufactured by Gol Daru Company and will be used as a topical solution diluted with sweet almond oil in a 1:1 ratio. This intervention will be performed for 3 consecutive days.</i_keyword>
      <i_keyword>Intervention Group 2: Abdominal Massage Without Peppermint Extract In this group, patients will receive abdominal massage twice daily for 15 minutes, similar to intervention group 1, but without the use of peppermint extract. The massage will be performed with a base oil (sweet almond oil), and the massage technique and location will be the same as in the first group. This intervention will also be performed for 3 consecutive days.</i_keyword>
      <i_keyword>Control group: : : No abdominal massage In this group, patients will receive only routine nursing care and common enteral feeding protocols in the ICU, without any additional interventions including massage or the use of topical agents</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The effect of Swedish massage with peppermint extract on residual volume in patients undergoing enteral nutrition. Timepoint: Three days in a row. Method of measurement: Gavage syringe and graduated cups.</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>Zabol University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-01-22</approval_date>
        <contact_name>Ethics Committee of Zabol University of Medical Sciences</contact_name>
        <contact_address>Block13 and14, Kohestan complex, North ISsargaran street, Book squere, Saadat abad, Tehran, IRan. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
