<?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>IRCT2014040617140N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-07-02</date_registration>
      <primary_sponsor>Vice Chancellor for Research of Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of acupressure on anxiety and respiratory parameters in ventilated patients</public_title>
      <acronym></acronym>
      <scientific_title>Effect of acupressure on anxiety and respiratory parameters in ventilated patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-09-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/15837</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Sampling is purposive, then patients will be assigned randomly to experimental  and control groups,  via a coin toss .</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patients with impaired respiratory function in ICU.</hc_freetext>
      <i_freetext>Intervention 1: Acupressure will perform in the experimental group. The intervention is performed two times per day over the two days and each session of intervention will be lasted 20 minutes .Also it is performed at certain times of day for each patient by a trained person. This technique will implement at the 5- acupoints on both sides of the body. The 5- acupoints include Zhongfu (Lu1), Taiyuan (Lu9), Hegu (Li4), Neiguan (Pc6) and Zusanli (St36). This technique is performed on one side of the body first and then the other side of the body, based on the patient's condition. Intervention 2: In control group, touch will perform at 5 acupoints in 2 sessions per day (morning and evening ) during 2 days of intervention period.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nasim Mehranfard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Dr Mirkhani St, Tohid Sq</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6692 7171</telephone>
        <email>nsmmehranfard@gmail.com</email>
        <affiliation>School of Nursing and Midwifery of Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Jaleh Mohammadaliha</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery,Rashid Yasemi St, Valiasr St,Tehran , Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8888 2885</telephone>
        <email>mohammadaliha.j@iums.ac.ir</email>
        <affiliation>School of Nursing and Midwifery of Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria :  GCS ≥ 9 ; Patient  intubated for past 24 hours; Are on ventilation with SIMV ،PSV ،CPAP or BIPAP mode;  Hemoglobin ≥ 8 mg/dl ;  Without malformation or grazes in pressure points ; Have no psychiatric illness ;  Have no neuromuscular illness ; Have no active heart disease  ; Have no neurologic disorder that affect on respiratory ; Are not taking any psychiatric agent ; Are not taking any neuromuscular blocker agent ;  Are not taking sedative during past 4 hours&#13;
&#13;
Exclusion criteria :Patient with  no cooperation to end of study ; Weaning of mechanical ventilation ;  Death of  patient during the study ;  Discharge from hospital</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J95 , J96 </hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other diseases of the respiratory system</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Acupressure will perform in the experimental group. The intervention is performed two times per day over the two days and each session of intervention will be lasted 20 minutes .Also it is performed at certain times of day for each patient by a trained person. This technique will implement at the 5- acupoints on both sides of the body. The 5- acupoints include Zhongfu (Lu1), Taiyuan (Lu9), Hegu (Li4), Neiguan (Pc6) and Zusanli (St36). This technique is performed on one side of the body first and then the other side of the body, based on the patient's condition.</i_keyword>
      <i_keyword>In control group, touch will perform at 5 acupoints in 2 sessions per day (morning and evening ) during 2 days of intervention period.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Respiratory parameter include expiratory tidal volume. Timepoint: Baseline , before, immediately after intervention, 15 minutes, every 30 minutes to 2 hours after the intervention in the morning and evening for two days and then one day after the last intervention. Method of measurement: Ventilator system.</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: Baseline , before, immediately after intervention and 2 hours after intervention in the morning and evening for two days and then one day after the last intervention . Method of measurement: Faces anxiety scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Blood gases include Arterial blood O2 ( Pao2 ). Timepoint: Baseline and 2 times per day during the intervention and follow-up. Method of measurement: ABG system.</sec_outcome>
      <sec_outcome>Arterial blood CO2. Timepoint: Baseline and 2 times per day during the intervention and follow-up. Method of measurement: ABG system.</sec_outcome>
      <sec_outcome>Arterial blood HCO3-. Timepoint: Baseline and 2 times per day during the intervention and follow-up. Method of measurement: ABG system.</sec_outcome>
      <sec_outcome>Blood PH. Timepoint: Baseline and 2 times per day during the intervention and follow-up. Method of measurement: ABG system.</sec_outcome>
      <sec_outcome>Respiratory parameters include Dynamic compliance. Timepoint: Baseline , before, immediately after intervention, 15 minutes, every 30 minutes to 2 hours after the intervention in the morning and evening for two days and then one day after the last intervention. Method of measurement: Ventilator system.</sec_outcome>
      <sec_outcome>Resistance. Timepoint: Baseline , before, immediately after intervention, 15 minutes, every 30 minutes to 2 hours after the intervention in the morning and evening for two days and then one day after the last intervention. Method of measurement: Ventilator system.</sec_outcome>
      <sec_outcome>Oxygen saturation of arterial blood ( SPo2 ). Timepoint: Baseline , before, immediately after intervention and 2 hours after intervention in the morning and evening for two days and then one day after the last intervention . Method of measurement: Pulsoximeter.</sec_outcome>
      <sec_outcome>Rapid shallow breathing index. Timepoint: Baseline , before, immediately after intervention, 15 minutes, every 30 minutes to 2 hours after the intervention in the morning and evening for two days and then one day after the last intervention. Method of measurement: Ventilator system.</sec_outcome>
      <sec_outcome>Respiratory  rate. Timepoint: Baseline , before, immediately after intervention, 15 minutes, every 30 minutes to 2 hours after the intervention in the morning and evening for two days and then one day after the last intervention. Method of measurement: Ventilator system.</sec_outcome>
      <sec_outcome>Minute ventilation. Timepoint: Baseline , before, immediately after intervention, 15 minutes, every 30 minutes to 2 hours after the intervention in the morning and evening for two days and then one day after the last intervention. Method of measurement: Ventilator system.</sec_outcome>
      <sec_outcome>Peak inspiratory pressure. Timepoint: Baseline , before, immediately after intervention, 15 minutes, every 30 minutes to 2 hours after the intervention in the morning and evening for two days and then one day after the last intervention. Method of measurement: Ventilator system.</sec_outcome>
      <sec_outcome>Vital signs affected by anxiety include blood pressure. Timepoint: Baseline , before, immediately after intervention and 2 hours after intervention in the morning and evening for two days and then one day after the last intervention. Method of measurement: Monitoring system.</sec_outcome>
      <sec_outcome>Heart rate. Timepoint: Baseline , before, immediately after intervention and 2 hours after intervention in the morning and evening for two days and then one day after the last intervention. Method of measurement: Monitoring system.</sec_outcome>
      <sec_outcome>Mean blood pressure. Timepoint: Baseline , before, immediately after intervention and 2 hours after intervention in the morning and evening for two days and then one day after the last intervention. Method of measurement: Monitoring system.</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>Vice Chancellor for Research of Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-05-25</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Sixth Floor, Central Organization of University, Qods St, Keshavarz Blvd Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
