<?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>IRCT20261102071649N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-11-06</date_registration>
      <primary_sponsor>Rafsanjan University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Virtual Reality Glasses on Childbirth Experience and Childbearing Desire</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Virtual Reality Glasses on Childbirth Experience and Childbearing Desire</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-11-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>84</target_size>
      <recruitment_status>Pending</recruitment_status>
      <url>https://irct.ir/trial/94559</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Mothers were selected using a convenience sampling method. A total of 84 pregnant women were randomly assigned to either an intervention group or a control group using a block randomization technique with a block size of 6 (generated via the computer program "CREATE A RANDOMISATION LIST" at https://www.sealedenvelope.com/simple-randomiser/v1/lists). In each randomization step, one permutation—selected at random from all possible permutations (e.g., AAABBB, ABAABB, ABBAAB, ABBBAA, BBBAAA, etc.) determined the allocation of participants into the intervention group (n=42) and the control group (n=42). The randomization sequence and group assignments were placed inside sequentially numbered, opaque, sealed envelopes. Upon the enrollment of each participant, the researcher opened the corresponding envelope to determine the participant's group allocation, Blinding description: Due to the nature of the intervention, blinding of participants and the researcher is not possible; however, statistical analysis will be performed by an individual who is unaware of the group assignments.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Childbirth Experience. Condition 2: Childbearing Desire.</hc_freetext>
      <i_freetext>Intervention group: Participants in the intervention group (n=42) will use an immersive virtual reality (VR) headset specifically the SHINECON G04BS model in addition to receiving routine obstetric care in accordance with hospital protocols. The content will consist of high-quality 360-degree videos featuring tranquil natural settings such as lakes, underwater scenes, the aurora borealis, and mountain landscapes accompanied by relaxing music. Before the intervention begins, the mothers will be shown samples of the available videos and may select the environments they prefer. The intervention will be administered in person by a researcher or a midwife within the labor ward. The first session will commence at the onset of the active phase of labor (cervical dilation of 6 cm) and will last for approximately 20 minutes.Provided the mother consents, experiences no discomfort from using the headset (such as dizziness, nausea, or general unease), and remains in the active phase of labor, the use of the headset may be repeated for another 20 minutes following a 10- to 15-minute rest period. As labor progresses and cervical dilation reaches approximately 8 to 9 centimeters, the headset may be used again for approximately 20 minutes, subject to the mother's preference. Should the mother wish to continue using the device and provided her clinical condition remains appropriate further sessions are permitted, up to a total cumulative duration of 60 minutes during the active phase of labor; the minimum duration for any single intervention session is 20 minutes..</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:
Details will be provided upon request.

When:
Access begins after the publication of results.

To whom:
Applications are open to academic, scientific, and industrial researchers.

Conditions:
Scientific and Research

Where to obtain:
Email of the person in charge
f.t.eskandarzade@gmail.com

How to obtain:
After authentication

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Eskandarzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ali Ibn Abi Taleb Square, Khalij-e Fars Boulevard, After Abuzar Street, Rafsanjan, Iran.</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7717747135</zip>
        <telephone>+98 34 3376 2446</telephone>
        <email>f.t.eskandarzade@gmail.com</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Eskandarzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ali Ibn Abi Taleb Square, Khalij-e Fars Boulevard, After Abuzar Street, Rafsanjan, Iran.</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7717747135</zip>
        <telephone>+98 34 3376 2446</telephone>
        <email>f.t.eskandarzade@gmail.com</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness to participate in the study and sign an informed consent form
Iranian nationality
Singleton pregnancy
Gestational age of 37 to 42 weeks
Absence of uncontrolled conditions such as hypertension, diabetes, or thyroid disorders
Being in the active phase of labor (6 cm cervical dilation)
Absence of known visual or hearing impairments that would preclude the use of virtual reality (VR) headsets
No history of diagnosed severe psychiatric disorders
Absence of active neurological conditions associated with seizures</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Unwillingness to continue participation at any stage of the research
Intolerance to the use of virtual reality (VR) headsets (e.g., dizziness, nausea, headache, or severe discomfort)
Failure to fully adhere to the intervention as per the research protocol
Incomplete questionnaires
Occurrence of any obstetric complication, including: labor dystocia, instrumental delivery, severe postpartum hemorrhage, umbilical cord prolapse, placental abruption, uterine rupture, seizures, or eclampsia
Performance of an emergency Cesarean section
Fetal distress or the need for emergency obstetric interventions</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Participants in the intervention group (n=42) will use an immersive virtual reality (VR) headset specifically the SHINECON G04BS model in addition to receiving routine obstetric care in accordance with hospital protocols. The content will consist of high-quality 360-degree videos featuring tranquil natural settings such as lakes, underwater scenes, the aurora borealis, and mountain landscapes accompanied by relaxing music. Before the intervention begins, the mothers will be shown samples of the available videos and may select the environments they prefer. The intervention will be administered in person by a researcher or a midwife within the labor ward. The first session will commence at the onset of the active phase of labor (cervical dilation of 6 cm) and will last for approximately 20 minutes.Provided the mother consents, experiences no discomfort from using the headset (such as dizziness, nausea, or general unease), and remains in the active phase of labor, the use of the headset may be repeated for another 20 minutes following a 10- to 15-minute rest period. As labor progresses and cervical dilation reaches approximately 8 to 9 centimeters, the headset may be used again for approximately 20 minutes, subject to the mother's preference. Should the mother wish to continue using the device and provided her clinical condition remains appropriate further sessions are permitted, up to a total cumulative duration of 60 minutes during the active phase of labor; the minimum duration for any single intervention session is 20 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Childbirth Experience. Timepoint: On the first day postpartum, and after the mother's general condition has stabilized. Method of measurement: Childbirth Experience Questionnaire 2.0.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Childbearing Desire. Timepoint: 6 weeks postpartum. Method of measurement: Researcher-developed questionnaire on the childbearing desire.</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>Rafsanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-10-28</approval_date>
        <contact_name>Ethics Committee of Rafsanjan University of Medical Sciences</contact_name>
        <contact_address>Central Headquarters, Rafsanjan University of Medical Sciences, Imam Ali Boulevard, Rafsanjan, Kerman, Iran. Rafsanjan Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
