<?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>IRCT20260619069866N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-06-30</date_registration>
      <primary_sponsor>Iranshahr University of Medical Sciences</primary_sponsor>
      <public_title>A comparative study of the effect of squats and butterfly movements on pain intensity and duration of labor stages.</public_title>
      <acronym></acronym>
      <scientific_title>A comparative study of the effect of squats and butterfly movements on pain intensity and duration of labor in primiparous women.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>84</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/91032</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Diagnostic, Other design features: This study is the first clinical trial in the study area to directly compare the effects of two non-pharmacological interventions, including squats and butterfly pose (Baddha konasana), on pain intensity and duration of labor in primiparous women. Both phases of the intervention are performed during the active phase of labor and in the real delivery room environment. Also, the existence of three parallel groups, including the squat group, the butterfly group, and the control group, allows for a precise comparison of the effectiveness of these two interventions with usual care. The results of this study can provide practical evidence for the use of simple, low-cost, safe, and feasible interventions in the delivery room, Randomization description: Sampling will be done by convenience sampling. In this way, primiparous women referring to the maternity ward of Iran Hospital, Iranshahr, who meet the inclusion criteria, were included in the study after receiving the necessary explanations and signing the informed consent form. 
After entering the study, participants will be assigned to one of three groups (squat exercise), (butterfly movement), (control group) using a block randomization method with an allocation ratio of 1:1:1.
The random sequence of blocks is prepared before the study begins by a person who is not involved in conducting the research and collecting the data, using random number generation software. 
The allocation sequence is placed in opaque, sealed, opaque, numbered, and consecutive envelopes. After meeting the entry requirements and obtaining informed consent, the researcher opens the envelope corresponding to the same number and allocates the participant to one of the three study groups based on the group designated in the envelope.
To prevent bias, the randomization sequence will be kept confidential until each participant is allocated, and it will not be possible to predict the assigned group. Given the nature of the intervention, blinding of participants and the researcher is not possible; however, statistical analysis of the data will be performed by someone who is unaware of the group allocation.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Child Birth.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: First intervention group: Squat movements are performed 5 times, each time for 3 to 5 deep breaths, held in the squat position for 30 seconds, and performed for 3 sets of 5, 30 seconds each, in 45 minutes. In the next 15 minutes, we will perform a vaginal examination and perform a triage, and a partograph form will be drawn. This process will continue until delivery. Intervention 2: Intervention group: Second intervention group: The butterfly movement group also performs butterfly movements for 2 minutes under the supervision of a midwife, and for 3 sets of 2 minutes at 15-minute intervals, the butterfly movement is performed for 45 minutes, and for the next 15 minutes, we will perform a vaginal examination and perform a tracheotomy, and a partograph form will be drawn. This process will continue until delivery. Intervention 3: Control group:  The third group, which is the control group, receives routine hospital care.To eliminate the placebo effect, non-specific movement or soft touch will be used for the control group.</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 or the like, can be shared.

When:
Access period starts 6 months after results are published.

To whom:
It will only be available to researchers working in academic and scientific institutions.

Conditions:
To write an article and if you have an academic email

Where to obtain:
To receive the required documents or data, applicants should send a message to the following email: 
mahtabkarimi7557@gmail.com
Contact number: 09906449438

How to obtain:
Data will be sent within a week after reading the email.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahtab karimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Moalem Boulevard</address>
        <city>Garmsar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3596177683</zip>
        <telephone>+98 23 3422 2233</telephone>
        <email>mahtabkarimi7557@gmail.com</email>
        <affiliation>Iranshahr University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahtab karimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fayyaz Bakhsh St., Kashani Blvd.,Takhti., Garmsar</address>
        <city>Garmsar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3596177683</zip>
        <telephone>+98 23 3422 2233</telephone>
        <email>mahtabkarimi7557@gmail.com</email>
        <affiliation>Iranshahr University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Primiparous women with gestational age 37 to 42 weeks
A singleton who has full consent to participate in the study.
Be a member of the Vertex embryo show
The fetal position is occiput anterior.
The mother is in the active phase and is 3 to 4 centimeters dilated.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Preterm birth
Fetal distress
Premature rupture of the water bag for more than 12 hours
Severe gestational hypertension
Preeclampsia and eclampsia
severe anemia
Abnormal presentation
twins
Receiving epidural or gastox anesthesia
Suspected pelvic stenosis
High maternal body mass index (more than 30)
Deculman and Pervia
History of previous caesarean section
Posterior occiput position
Suspected fetal macrosomia
Maternal joint and skeletal problems
Doubt to FGR
Congenital fetal anomaly
Known chronic disease in the mother (heart, kidney, diabetes, etc.).
Attend childbirth preparation classes and yoga during pregnancy
Mother's withdrawal from participation in the study at any stage of the research
Any factor that causes an emergency cesarean section
Use of vacuum
Receiving any type of pain relief during the study
If any abnormal changes occur in the fetal ECG or fetal distress occurs during the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Diagnosis</i_code>
      <i_code>Diagnosis</i_code>
      <i_code>Diagnosis</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: First intervention group: Squat movements are performed 5 times, each time for 3 to 5 deep breaths, held in the squat position for 30 seconds, and performed for 3 sets of 5, 30 seconds each, in 45 minutes. In the next 15 minutes, we will perform a vaginal examination and perform a triage, and a partograph form will be drawn. This process will continue until delivery.</i_keyword>
      <i_keyword>Intervention group: Second intervention group: The butterfly movement group also performs butterfly movements for 2 minutes under the supervision of a midwife, and for 3 sets of 2 minutes at 15-minute intervals, the butterfly movement is performed for 45 minutes, and for the next 15 minutes, we will perform a vaginal examination and perform a tracheotomy, and a partograph form will be drawn. This process will continue until delivery.</i_keyword>
      <i_keyword>Control group:  The third group, which is the control group, receives routine hospital care.To eliminate the placebo effect, non-specific movement or soft touch will be used for the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Gestational age. Timepoint: Before intervention. Method of measurement: Based on the week of pregnancy recorded in the pregnancy record.</prim_outcome>
      <prim_outcome>Economic situation. Timepoint: Before intervention. Method of measurement: Based on participant self-declaration and demographic information questionnaire.</prim_outcome>
      <prim_outcome>The length of the first stage of labor. Timepoint: During the intervention. Method of measurement: From 3 cm to 10 cm dilation.</prim_outcome>
      <prim_outcome>Length of the second stage of labor. Timepoint: During the intervention. Method of measurement: From 10 cm dilation to delivery of the fetus.</prim_outcome>
      <prim_outcome>Desire to get pregnant. Timepoint: Before intervention. Method of measurement: Based on participant self-declaration and demographic information questionnaire.</prim_outcome>
      <prim_outcome>Wife's job. Timepoint: Before intervention. Method of measurement: Based on participant self-declaration and demographic information questionnaire.</prim_outcome>
      <prim_outcome>Spouse's level of education. Timepoint: Before intervention. Method of measurement: Based on participant self-declaration and demographic information questionnaire.</prim_outcome>
      <prim_outcome>Mother's job. Timepoint: Before intervention. Method of measurement: Based on participant self-declaration and demographic information questionnaire.</prim_outcome>
      <prim_outcome>Mother's level of education. Timepoint: Before intervention. Method of measurement: Based on participant self-declaration and demographic information questionnaire.</prim_outcome>
      <prim_outcome>Severity of labor pain. Timepoint: After the intervention. Method of measurement: Measurement with a visual pain scale from zero to 10 at specific time intervals.</prim_outcome>
      <prim_outcome>Mother's height. Timepoint: Before intervention. Method of measurement: According to the measurement carried out.</prim_outcome>
      <prim_outcome>Mother's weight. Timepoint: Before intervention. Method of measurement: According to the measurement carried out.</prim_outcome>
      <prim_outcome>Squat movements. Timepoint: During the intervention. Method of measurement: Performing squats according to the prescribed protocol.</prim_outcome>
      <prim_outcome>Butterfly movements. Timepoint: During the intervention. Method of measurement: Performing the butterfly movement according to the established protocol.</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>Iranshahr University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-01-31</approval_date>
        <contact_name>Ethics committee of iranshahr university of medical sciences</contact_name>
        <contact_address>Moalem Boulevard Iranshahr Sistan-va-Balouchestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
