<?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>IRCT20251112067968N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-12-25</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Effectiveness of Cooling Strategies (Neck Cooling and Menthol Mouth Rinse) on Thermo-Perceptual and Physiological Responses in Hijab-Wearing Female Futsal Players</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of Cooling Strategies (Neck Cooling and Menthol Mouth Rinse) on Thermo-Perceptual and Physiological Responses in Hijab-Wearing Female Futsal Players</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-12-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/87477</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Crossover, Purpose: Health service research, Other design features: Quasi-experimental crossover trial with repeated measures and a 2×2 factorial structure, in which each participant completes four conditions: menthol mouth rinse (MEN), neck cooling (NEC), combined (MEN+NEC), and control (CON). The order of conditions is determined by block randomization, with at least 72 hours between sessions. The protocol is conducted in an indoor futsal hall under controlled hot-dry conditions (34±1°C, 20–30% RH), Randomization description: This study employed a randomized, counterbalanced crossover design.
To determine the order of participation in the four intervention conditions, including menthol MEN, NEC, MEN+NEC, and control, the intervention sequences were randomly and counterbalanced using a Latin-square design, ensuring that each condition was equally distributed across different time positions to minimize order and period effects. The intervention sequences were generated by an independent researcher prior to the start of the study, and allocation was concealed using sealed, opaque envelopes.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Exercise in heat condition.</hc_freetext>
      <i_freetext>Intervention 1: First group: Menthol Mouth Rinse (MEN): Rinsing with 25 mL of 0.1% L-Menthol solution for 10 seconds and then expectorating. Intervention 2: Second group: Neck Cooling (NEC): Application of a phase-change material (PCM) cooling pack (initial temperature approximately 2-4°C) to the neck area. Intervention 3: Intervention group: Third Intervention (MEN+NEC): Simultaneous application of both the menthol mouth rinse and the neck cooling. Intervention 4: Control group: Placebo mouth rinse (non-menthol solution with similar taste) and application of a non-cooling neck pack.</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:
All data without participant names

When:
6 months after publication of the article

To whom:
University students and professors

Conditions:
For future research

Where to obtain:
To the researchers of this study

How to obtain:
By email to researchers

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Akram Jafari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahrekord, Islamic Azad University, Shahrekord Branch</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>881863003</zip>
        <telephone>+98 38 3336 1001</telephone>
        <email>Jafari.akm@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Akram Jafari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 10, Alley 75, Bahonar Street, Shahrekord</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>881863003</zip>
        <telephone>+98 38 3336 1001</telephone>
        <email>Jafari.akm@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Female sex
Age range of 18 to 30
Years Minimum of two years of regular futsal training experience
Consistent use of sports hijab during training and competitions
General health confirmed by a sports medicine physician</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>30 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Intolerance to menthol mouth rinse or occurrence of skin irritation from neck cooling
Suffering from an acute illness during the research execution period
Failure to complete at least one test session
Use of medications affecting the cardiovascular, respiratory, or thermoregulatory systems</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>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First group: Menthol Mouth Rinse (MEN): Rinsing with 25 mL of 0.1% L-Menthol solution for 10 seconds and then expectorating.</i_keyword>
      <i_keyword>Second group: Neck Cooling (NEC): Application of a phase-change material (PCM) cooling pack (initial temperature approximately 2-4°C) to the neck area.</i_keyword>
      <i_keyword>Intervention group: Third Intervention (MEN+NEC): Simultaneous application of both the menthol mouth rinse and the neck cooling.</i_keyword>
      <i_keyword>Control group: Placebo mouth rinse (non-menthol solution with similar taste) and application of a non-cooling neck pack.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Best sprint time. Timepoint: Calculated post-protocol after data collection. Method of measurement: Calculated using a standard formula based on the sprint times recorded across the 10 repetitions.</prim_outcome>
      <prim_outcome>Performance Decrement Index. Timepoint: Upon the completion of the protocol and the collection of all temporal data. Method of measurement: Statistical analysis was performed using the standardized performance decrement formula, derived from the recorded times across 10 sprint repetitions.</prim_outcome>
      <prim_outcome>Skin Temperature. Timepoint: Pre, during, and post-activity phases. Method of measurement: Measured using skin thermistors placed on specific body sites.</prim_outcome>
      <prim_outcome>Heart Rate. Timepoint: With smartwatch-integrated sensors. Method of measurement: Longitudinal monitoring across the pre-, intra-, and post-activity phases.</prim_outcome>
      <prim_outcome>Sweat Rate &amp; Body Mass Loss. Timepoint: Body weight measured immediately before the protocol and immediately after completion. Method of measurement: Calculated by comparing pre- and post-activity body weight (without fluid intake during the test).</prim_outcome>
      <prim_outcome>Rating of Perceived Exertion. Timepoint: After the exercise protocol. Method of measurement: Measured using the Borg Scale (range 6–20).</prim_outcome>
      <prim_outcome>Thermal Sensation &amp; Thermal Comfort. Timepoint: Before, during, and after the exercise protocol. Method of measurement: Measured via standardized thermal sensation and comfort questionnaires.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-12-20</approval_date>
        <contact_name>Islamic Azad University,  Shahrekord Branch</contact_name>
        <contact_address>No. 10, 75th Alley, Ba Honar Street, Shahrekord Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
