<?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>IRCT20181214041963N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-12-27</date_registration>
      <primary_sponsor>Gonabad University of Medical Sciences</primary_sponsor>
      <public_title>Comparing the Effectiveness of Virtual Reality and Chewing Gum on intensity of pain, Anxiety and Mothers Satisfaction from Labor Experience</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the Effectiveness of Virtual Reality and Chewing Gum on intensity of pain, Anxiety and Mothers Satisfaction from Labor Experience</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>93</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/36240</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The division of people into each of the three groups (chewing gum, virtual reality, and control) will be done randomly, in this way, a number of cards to select a researcher (in line with sample size or more) as a chewing gum group (card Green) and the same number of cards for the virtual reality group (red card) and the same number of cards for the control group (white card), then by merging the cards together (flipping) the cards inside A black box is poured. A sample card is issued by each individual and its allocation is recorded, and that card is returned to the other cards after it is exited. Then the cards are merged again and another card is removed. This process continues to reach a random sequence according to sample size, Blinding description: Participants are not aware of which group (chewing gum and intervention group, seeing virtual reality or control film) are not known (one-way blind). In the maternity research environment, each woman gives birth to her own room, so the research units do not deal with each other.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Labor pain, Anxiety from childbirth, Satisfaction with delivery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Group 1 Chewing gum 1 grams without sugarcane orbit for 20 minutes twice (dilation of 3-5 cm and 7-8 cm). Intervention 2: Intervention group: GRouh 2 Interventions of virtual reality films with special glasses for 20 minutes twice (dilatation of 3.5 cm and 7-8 cm) were used for this study of distorted modes of view such as the river, the beach, the waterfall, and the lake. Intervention 3: Control group: No intervention will take place.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Atefeh Ebrahimiyan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Asian Road Rim, Gonabad University of Medical Sciences</address>
        <city>Gonabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9691793718</zip>
        <telephone>+98 51 5722 3028</telephone>
        <email>ebrahimiyan127@gmail.com</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Roghaieh Rahmani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Asian Road Rim, Gonabad University of Medical Sciences</address>
        <city>Gonabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۹۶۹۱۷۹۳۷۱۸</zip>
        <telephone>+98 51 5722 3028</telephone>
        <email>roghaiehrahmany@yahoo.com</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Live Embryo
Singetone Pregnancy
Mother's age is between 18 and 35 years old
The Gestational Age is 37-42 weeks (based on the first day of the last Menstruation or first trimester Sono)
A Dilatation of 3-5 cm with regular Uterine contractions indicating active phase
Satisfaction to Participate in the Research
Without known medical conditions based on patient records (including history of or current infection to any systemic disease, such as Diabetes, High Blood Pressure, Heart Disease, Kidney, Nervous, Liver, Gastrointestinal, Respiratory, Thyroid)
Not having an abnormal Embryo or limiting intrauterine growth
Vertex Expansion
Low risk pregnancy (lack of infertility, pre-eclampsia,Placenta Previa , Placental abruption)
Decolmers are normal at the acceptance of normal fetal heart rate (no tachycardia with fetal heart rate greater than 160, bradycardia with pulmonary heart rate of less than 110, late dropout, and severe drop in heart rate)
The embryonic curtains are healthy or less than 12 hours since they were torn
Lack of history of mental illness
No history of motion Sickness
Not blind</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Mother's unwillingness to cooperate
Occurrence of Midwifery problems (Placental abruption during labor, fast delivery, fetal distress, intra uterine death,Thick meconium )
Chewing Gum less than 20 minutes
Less than 20 minutes of virtual reality movie viewing
Use of Entonox and Spinal and Epidural Anesthetics</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>080-084</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Delivery</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: Group 1 Chewing gum 1 grams without sugarcane orbit for 20 minutes twice (dilation of 3-5 cm and 7-8 cm)</i_keyword>
      <i_keyword>Intervention group: GRouh 2 Interventions of virtual reality films with special glasses for 20 minutes twice (dilatation of 3.5 cm and 7-8 cm) were used for this study of distorted modes of view such as the river, the beach, the waterfall, and the lake.</i_keyword>
      <i_keyword>Control group: No intervention will take place.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Labor pain. Timepoint: Before the intervention, immediately after the intervention and 30 minutes after the intervention. Method of measurement: Visual Analog Scale of Pain.</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: Before the intervention, immediately after the intervention and 30 minutes after the intervention. Method of measurement: Spielberger state questionnaire.</prim_outcome>
      <prim_outcome>Childbirth satisfaction. Timepoint: Postpartum. Method of measurement: Mackey Childbirth Satisfaction Rating Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Duration of active phase of labor. Timepoint: After the intervention. Method of measurement: Kronometer.</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>Gonabad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-12-03</approval_date>
        <contact_name>Ethics Committee of Gonabad University of Medical Sciences</contact_name>
        <contact_address>Asian Roadside Border Gonabad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
