<?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>IRCT20200206046395N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-01-21</date_registration>
      <primary_sponsor>Shahroud University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of acupressure at LI4 point and gum chewing on reactivation of gastrointestinal system after cesarean section:</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of acupressure at LI4 point and gum chewing on reactivation of gastrointestinal system after cesarean section: A Parallel Randomized Clinical Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-02-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>105</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/75019</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In the beginning, all the modes in which 3 letters A, B and C can be put together in a block of 6 are produced and a block is selected randomly and by placing among the blocks.The layout pattern in that block is used to allocate patients, Blinding description: Due to the nature of the study, it is not possible to blind the study participants. However, measures were taken in collecting information. After the intervention, the person collecting the information will not know the type of the participants' group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Postoperative Gastrointestinal Tract Dysfunction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the chewing gum group, a pack of Van brand gum (manufactured by Kurdistan Turpentine Company) containing xylitol is provided to the patients. They are asked to chew a piece of gum for at least 20 minutes 3 times a day before eating breakfast, lunch and dinner. Intervention 2: Intervention group: After the operation and after transferring the patients to the ward, acupressure will be performed 3 times a day for 20 minutes.In the acupressure group, the researcher will first wash his hands and warm the hands by touching them, he will ask the patient to be in the desired position, then by finding the LI4 point, he will massage the acupressure slowly and gently. It will be applied for 30 seconds. Gradually this pressure will increase until the patient feels tingling, numbness, heaviness and stretching around the area for 30 seconds. Then it is kept in the same position for 1 minute and gradually after that the pressure will be reduced for 30 seconds. Finally, 30 seconds will be held in the same position and 2 minutes of rest will be applied. Each cycle of this process will last 5 minutes, a total of four alternating 5-minute cycles for both hands will last about 20 minutes. Intervention 3: Control group: In the control group, routine measures such as recommendations for: 1- liquid consumption, 2- fiber consumption, 3- performing active and passive movements in bed will be performed.</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:
Only part of the data, such as information related to the main outcome, can be shared.

When:
The access period starts 6 months after the results are published

To whom:
Only for researchers working in academic and scientific institutions

Conditions:
If necessary, by contacting Mobin Mottahedi and if there is a logical justification for using it for scientific purposes

Where to obtain:
Mobin Mottahedi, Shahrood, Haft Tir Square, Shahrood University of Medical Sciences; Faculty of paramedicine

How to obtain:
During a phone call or via e-mail and registering the request and stating the reason and purpose, which is logical and approved, up to two weeks

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mobin Mottahedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahroud University of Medical Sciences, Haft Tir Square, Shahroud</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3614773955</zip>
        <telephone>+98 23 3233 8457</telephone>
        <email>mobinmottahedi1372@gmail.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mobin Mottahedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahroud University of Medical Sciences, Haft Tir Square, Shahroud</address>
        <city>Shahrood</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3614773955</zip>
        <telephone>+98 23 6548 7520</telephone>
        <email>mobinmottahedi1372@gmail.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Elective caesarean section with spinal anesthesia
Healthy condition of the teeth for chewing gum
Not having any lesions in the acupressure area
Ability to read and write in Persian
Being in the 38th to 42nd week of pregnancy
Age 18 to 35 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Lack of consciousness of the patient after the operation
Change in anesthesia method (conversion to general anesthesia)
Injury to the intestine and bladder during surgery
Any type of postoperative complication (patients with more than 1000 ml of postpartum bleeding)
Drug and alcohol addiction according to the patient's statements
Having diarrhea, chronic constipation, gastric reflux and irritable bowel syndrome according to the patient's statement
Having language, hearing or vision disorders</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K55-K64</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other diseases of intestines</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the chewing gum group, a pack of Van brand gum (manufactured by Kurdistan Turpentine Company) containing xylitol is provided to the patients. They are asked to chew a piece of gum for at least 20 minutes 3 times a day before eating breakfast, lunch and dinner.</i_keyword>
      <i_keyword>Intervention group: After the operation and after transferring the patients to the ward, acupressure will be performed 3 times a day for 20 minutes.In the acupressure group, the researcher will first wash his hands and warm the hands by touching them, he will ask the patient to be in the desired position, then by finding the LI4 point, he will massage the acupressure slowly and gently. It will be applied for 30 seconds. Gradually this pressure will increase until the patient feels tingling, numbness, heaviness and stretching around the area for 30 seconds. Then it is kept in the same position for 1 minute and gradually after that the pressure will be reduced for 30 seconds. Finally, 30 seconds will be held in the same position and 2 minutes of rest will be applied. Each cycle of this process will last 5 minutes, a total of four alternating 5-minute cycles for both hands will last about 20 minutes.</i_keyword>
      <i_keyword>Control group: In the control group, routine measures such as recommendations for: 1- liquid consumption, 2- fiber consumption, 3- performing active and passive movements in bed will be performed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>First time gas passing after cesarean. Timepoint: 3 times a day, every 8 hours. Method of measurement: Ask the patient.</prim_outcome>
      <prim_outcome>The time of defecation for the first time after cesarean section. Timepoint: 3 times a day, every 8 hours. Method of measurement: Ask the patient.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The level of pain at the surgical site. Timepoint: 3 times a day, every 8 hours. Method of measurement: Visual Analogue Scale (VAS).</sec_outcome>
      <sec_outcome>Severe nausea and vomiting. Timepoint: 3 times a day, every 8 hours. Method of measurement: Visual Analogue Scale (VAS).</sec_outcome>
      <sec_outcome>Number of times vomiting. Timepoint: 3 times a day, every 8 hours. Method of measurement: Ask the patient.</sec_outcome>
      <sec_outcome>Duration of hospitalization. Timepoint: Until the end of discharge from the hospital. Method of measurement: Documents recorded in the patient's file.</sec_outcome>
      <sec_outcome>Time to start moving the patient for the first time after cesarean section. Timepoint: 3 times a day, every 8 hours. Method of measurement: Ask the patient.</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>Shahroud University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-01-10</approval_date>
        <contact_name>Ethics Committee of Shahrood University of Medical Sciences</contact_name>
        <contact_address>Shahroud University of Medical Sciences, Haft Tir Square, Shahroud Shahroud Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
