<?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>IRCT20230913059429N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-10-07</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>Comparison the effect of Swedish abdominal massage and Tensegrity on nasogastric tube complications in patients hospitalized in the intensive care unit</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the effect of Swedish abdominal massage and Tensegrity on nasogastric tube complications in patients hospitalized in the intensive care unit</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-10-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72729</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Sampling is done in an easy way based on the conditions of entry into the study and the samples are allocated to the control and intervention groups based on the randomization list provided by the statistician. The randomization list is prepared using R software, Blinding description: In this study, the patient and the patient's guardian, the evaluator who examines the parameters of the outcomes under investigation, and the respected statistician who performs the data analysis, are unaware of the study groups and the type of intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>In patients hospitalized in the intensive care unit.</hc_freetext>
      <i_freetext>Intervention 1: In the first intervention group, Tensegrity massage technique (5-stage massage) is used, the first stage includes movements such as brushing the skin of the abdominal area, the second stage changes the flexibility of the tracholumbar fascia, the third stage is kneading the skin of the abdominal area, and the fourth stage is impact movements. along the armpit from top to bottom and bottom to top and the last stage includes changing the elastic shape of the muscles in the interstitial spaces. The intervention period is 3 days. These patients receive 20 minutes of abdominal massage intervention twice a day and the interval between Two massages are 2 hours. Intervention 2: Intervention group 2: Swedish massage techniques including stroking, Efleurage,  kneading, and vibration are used. The intervention period is 3 days. These patients receive 20 minutes of abdominal massage intervention twice a day, and the interval between two massages is 2 hours. Intervention 3: Control group: Feeding and gavage of the patient will be done in the same way as other intervention groups, except that they will not only receive abdominal massage.</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 "There is no further information".</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Abdollah Abolfathi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3819693345</zip>
        <telephone>+98 86 3417 3524</telephone>
        <email>A.abolfathi@arakmu.ac.ir</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Kobra Rahzani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>٣٨١٩٦٩٣٣٤٥</zip>
        <telephone>+98 86 3417 3524</telephone>
        <email>k.rahzani@yahoo.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Feeding with nasogastric tube
Age between 18 and 65 years
A maximum of 3 times have passed since the start of digestive feeding
Not receiving prokinetic drugs such as: metoclopramide and anticholinergics such as: atropine and laxatives, erythromycin, cisapride
Glasgow Coma score below 9
No radiotherapy and abdominal surgery in the last 6 weeks
Absence of contraindications to abdominal massage with the examination and approval of a special care physician such as: severe trauma, cellulitis, abdominal mass, peritonitis, abdominal aneurysm, ascites, diverticulitis, spinal cord injury
The absence of any thromboembolism in the last year
Absence and history of Deep Vein Thrombosis in the last year
Absence of problems affecting excretion such as anorectal disorders</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></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>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the first intervention group, Tensegrity massage technique (5-stage massage) is used, the first stage includes movements such as brushing the skin of the abdominal area, the second stage changes the flexibility of the tracholumbar fascia, the third stage is kneading the skin of the abdominal area, and the fourth stage is impact movements. along the armpit from top to bottom and bottom to top and the last stage includes changing the elastic shape of the muscles in the interstitial spaces. The intervention period is 3 days. These patients receive 20 minutes of abdominal massage intervention twice a day and the interval between Two massages are 2 hours.</i_keyword>
      <i_keyword>Intervention group 2: Swedish massage techniques including stroking, Efleurage,  kneading, and vibration are used. The intervention period is 3 days. These patients receive 20 minutes of abdominal massage intervention twice a day, and the interval between two massages is 2 hours.</i_keyword>
      <i_keyword>Control group: Feeding and gavage of the patient will be done in the same way as other intervention groups, except that they will not only receive abdominal massage.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Gastric Residual Volume. Timepoint: Before the intervention (immediately before the start of abdominal massage) and one hour after the intervention (second massage) during each day separately. Method of measurement: Aspirating stomach contents with a 50 cc gavage syringe.</prim_outcome>
      <prim_outcome>Abdominal circumference size. Timepoint: Before the intervention and one hour after the intervention (second massage) during each day separately. Method of measurement: Using a special flexible meter.</prim_outcome>
      <prim_outcome>Defecation per day. Timepoint: Every day. Method of measurement: Counting the number of defecation.</prim_outcome>
      <prim_outcome>Ventilator associated pneumonia. Timepoint: Immediately before the start of the intervention on the first day and at the end of the third day of the intervention. Method of measurement: Modified Clinical Pulmonary Infection Score.</prim_outcome>
      <prim_outcome>Aspiration. Timepoint: Half an hour before the intervention and one hour after the intervention (second massage) during each day separately. Method of measurement: Using pH strips and glucose meters, the pH and glucose of aspirated secretions from the patient's airways are determined.</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>Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-08-01</approval_date>
        <contact_name>Ethics committee of Arak University of Medical Sciences</contact_name>
        <contact_address>A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran Arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
