<?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>IRCT20151211025477N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-12-28</date_registration>
      <primary_sponsor>Zanjan University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of two methods of distraction thinking and Therapeutic touch in reducing labor pain in nulliparous women</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of two methods of distraction thinking and Therapeutic touch in reducing labor pain in nulliparous women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-11-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66761</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Sampling in this research will be done in an easy and accessible way and based on the entry criteria.Allocation of participants to 3 groups will be done by random block method in 12 blocks of 6.In such a way, two people from the first intervention group (AA), two people from the second intervention group (BB) and two people from the control group will be present in each block.Then the different states of placing these people in the blocks will be predicted and a number will be assigned to each state, then the required number of random numbers will be extracted from the table of random numbers until the study sample size is reached, and based on them, the arrangement of the participants in Groups will be determined. Matte envelopes will be prepared by the thesis advisor before sampling and will be numbered according to the sample volume. Within each envelope, the allocation of a person to one of the study groups will be determined based on the random allocation of the block. Then, at the time of entering the study, the envelope will be selected based on the participant's code and opened in their presence, and the selected person will be placed in one of the three groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Delivery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: For.Therapeutic touch technique, a 45-minute counseling session will be held according to the protocol during pregnancy. Then, in the active phase of labor (dilation of 6 cm until entering the second stage of labor), the researcher will touch the hands of the people of this group for 15 minutes with rhythmic and calm movements (without any pressure) at the beginning of the mother's pains. Intervention 2: Intervention group:For the Distraction technique (watching the movie), four 45-minute counseling sessions will be held one week apart based on the existing protocol during pregnancy. Then the researcher will play 15-minute clips (with different pre-prepared contents) according to the mother's interests in the active phase of labor (6 cm dilation until entering the second stage of labor) at the beginning of the mother's pain. Intervention 3: Control group: Routine 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 Due to the confidentiality of the data</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Bakhtiari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Omran Posti St، Jhanbazan St</address>
        <city>Khalkhal</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5681863435</zip>
        <telephone>+98 45 3241 1099</telephone>
        <email>mhy.bakhtairi@gmail.com</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Elahe Ahmadnia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zanjan University of Medical Sciences, Gavazang Road</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4515613191</zip>
        <telephone>+98 24 3314 8300</telephone>
        <email>Ahmad@zums.ac.ir</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>nulliparous women in the age range of 15-35 years
Pregnancy without maternal and fetal complications
Gestational age 28-32 weeks
Willingness to participate in research
Having a phone and contact number
Not having hearing and vision problems
Obtaining an average pain score from the visual pain scale
Willingness to have a natural birth at the Imam Khomeini (RA) Khalkhal Educational and Medical Hospital
Has at least middle school education</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Indications for cesarean include: abnormal presentation of the fetus, pelvic stenosis, large fetus
Occurrence of adverse fetal outcomes
Inability to understand the scale of the pain ruler
Analgesic  injection</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O80.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Single spontaneous delivery, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: For.Therapeutic touch technique, a 45-minute counseling session will be held according to the protocol during pregnancy. Then, in the active phase of labor (dilation of 6 cm until entering the second stage of labor), the researcher will touch the hands of the people of this group for 15 minutes with rhythmic and calm movements (without any pressure) at the beginning of the mother's pains.</i_keyword>
      <i_keyword>Intervention group:For the Distraction technique (watching the movie), four 45-minute counseling sessions will be held one week apart based on the existing protocol during pregnancy. Then the researcher will play 15-minute clips (with different pre-prepared contents) according to the mother's interests in the active phase of labor (6 cm dilation until entering the second stage of labor) at the beginning of the mother's pain.</i_keyword>
      <i_keyword>Control group: Routine care</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Labor pain score. Timepoint: Before and after the intervention. Method of measurement: Visual analog pain scale (WONG-BAKER Pain Scale) to prevent misappropriation by the colleague present in the block who is unaware of the type and process of the intervention and the pain ruler (VAS = Visual Analogue Scale) by the mother herself once every hour in the phase Active labor (from the entry of the participating women to dilation of 6 cm until the entry into the second stage of labor) will be measured.</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>Zanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-10-28</approval_date>
        <contact_name>The Ethics Committee of Zanjan University of Medical Sciences</contact_name>
        <contact_address>Zanjan University of Medical Sciences، Azadi Blvd, Zanjan Zanjan Zanjan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
