<?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>IRCT20191221045832N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-01-09</date_registration>
      <primary_sponsor>Esfarayen University of Medical Sciences</primary_sponsor>
      <public_title>The effect of virtual reality on labor pain</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of virtual reality and acupressure on pain intensity and duration of the first stage of labor on primiparous</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>33</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/44525</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Sampling is done by random permutation blocks. So that 6 blocks of 20 and one of 12 blocks are specified. Within 5 blocks, 5 replicates and 3 replicates in each block were randomly assigned using unbiased coin method. After specifying the samples in each block, the blocks are also randomly selected.</study_design>
      <phase>N/A</phase>
      <hc_freetext>labor pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Virtual Reality Group: 33 people with inclusion criteria turn their eyes on the active phase of the virtual reality headset that will use distracting three-dimensional landscapes such as beach, river and waterfall. Intervention 2: Intervention group: Acupuncture group: With the onset of the first contraction, points L14 and SP6 are gently pressed for 30 seconds and gradually added to the pressure level to become completely intense. The thumb is then held in place for 1 minute and then the pressure is gradually lowered, releasing the point within 30 seconds. This intervention is performed for 20 minutes only during contractions. Intervention 3: Intervention group: Combining Acupuncture and Virtual Reality Interventions. Intervention 4: Control group: Routine childbirth care.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ameneh Safari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Reza Street, Shahid Rajaee, Esfarayen Faculty Of Medical Sciences</address>
        <city>Esfarayen</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9661876981</zip>
        <telephone>+98 58 3155 0617</telephone>
        <email>a.safari@esfrums.ac.ir</email>
        <affiliation>Esfarayen University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ameneh Safari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Reza Street, Shahid Rajaee, Esfarayen Faculty of Medical Sciences</address>
        <city>Esfarayen</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9661876981</zip>
        <telephone>+98 58 3155 0617</telephone>
        <email>safari.a@esfrums.ac.ir</email>
        <affiliation>Esfarayen University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>To have informed consent.
Iranian citizenship.
Be married.
At least a diploma degree.
First childbirth.
The gestational age is 37 weeks to 41 weeks. (Based on Sono first trimester abdominal or vaginal or first day of last menstruation).
Pregnancy asked.
Have a live, healthy and singleton fetus.
Show the vertex embryo.
Do not have a high-risk pregnancy.
Do not use opiates, alcohol or psychotropic drugs
No primary indication for cesarean section.                                               Not suffering from chronic diseases (diabetes, hypertension, heart, lung).
Do not suffer from specific skin diseases and eye diseases.
She plans to give birth at Imam Khomeini Hospital in Esfarayen.
There have been no accidents for the mother in the past six months.
The active phase of labor has begun.
The age of the mother is between 18 and 35 years.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Have a history of hypertension or gestational diabetes.
Have a family history of difficult childbirth
The fetus weighs more than 4 kg.
Amniotic fluid index greater than 24 cm.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O80.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pregnancy, childbirth and the puerperium, Delivery, spontaneous vertex delivery</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Virtual Reality Group: 33 people with inclusion criteria turn their eyes on the active phase of the virtual reality headset that will use distracting three-dimensional landscapes such as beach, river and waterfall.</i_keyword>
      <i_keyword>Intervention group: Acupuncture group: With the onset of the first contraction, points L14 and SP6 are gently pressed for 30 seconds and gradually added to the pressure level to become completely intense. The thumb is then held in place for 1 minute and then the pressure is gradually lowered, releasing the point within 30 seconds. This intervention is performed for 20 minutes only during contractions.</i_keyword>
      <i_keyword>Intervention group: Combining Acupuncture and Virtual Reality Interventions</i_keyword>
      <i_keyword>Control group: Routine childbirth care</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Visual Analogue Scale of Pain. Timepoint: Pain score before intervention, 5 to 7 cm cervical dilatation, 8 to 10 cm cervical dilatation. Method of measurement: Visual Analogue Scale for pain.</prim_outcome>
      <prim_outcome>Duration of active phase of labor per hour. Timepoint: duration of labor from 5 cm to 10 cm. Method of measurement: stopwatch for active phase duration.</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>Esfarayen University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-12-09</approval_date>
        <contact_name>Ethics Committee Of Esfarayen Faculty Of Medical Sciences</contact_name>
        <contact_address>Imam Reza Street, Shahid Rajaei, EsfarayenEaculty Of Medical Sciences Esfarayen North Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
