<?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>IRCT20260601069604N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-07-18</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of foot reflexology massage on sleep and stress and Anxiety of nurses</public_title>
      <acronym></acronym>
      <scientific_title>The effect of foot reflexology massage on sleep and stress and Anxiety of nurses</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-06-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>106</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/90597</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: After preparing the list of participants and randomly selecting two intervention and control groups, the participants in the intervention group were given practical training and educational aids were provided to them. Only the intervention group was given private training on the method of performing the work. The outcome of the intervention was examined by the evaluator through the completion of questionnaires. The data analyst was blinded and did not know which sample belonged to which group, Randomization description: "Participants will be randomly assigned to either the intervention group or the control group  using a permuted block randomization method. To ensure an equal allocation ratio throughout the study and to prevent predictable patterns, variable block sizes (4  will be employed.
The randomization sequence will be generated by an independent investigator, who is not involved in the recruitment or treatment process, using [Random Allocation Software ]. To maintain strict allocation concealment, the sequence will be implemented using sequentially numbered, opaque, sealed envelopes. These envelopes will only be opened by the investigator at the time of enrollment and after obtaining informed consent, ensuring that the investigators and participants remain blinded to the allocation until the moment of intervention, Blinding description: To ensure a balanced sample size in the intervention and control groups and to prevent time-related bias, a block randomization method was used with Stata software. In this method, participants were divided into blocks of 4 such that in each block the number of individuals assigned to both groups was equal.</study_design>
      <phase>3</phase>
      <hc_freetext>Occupational stress and sleep quality in nursing professionals.</hc_freetext>
      <i_freetext>Intervention 1: After grouping and practical training for the intervention group in internal programs, a group of members is formed and an educational video is prepared. Before the start of each session, the video is uploaded and provided to them. Socks are prepared and the individuals wear them. The desired points are marked with a marker and given to the individual. At the end of each week, after 3 sessions (per week), an electronic questionnaire is provided to the participants and completed. Intervention 2: Control group: Only the questionnaire is completed every week without any intervention.</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 There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Sarlak</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 1,babai ave,befor 21 metri, hashemi street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1336616351</zip>
        <telephone>+98 21 6550 3326</telephone>
        <email>sarlak.zahra32@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shokoh varaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tohid Square, East Nosrat Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>0982144061119</telephone>
        <email>shvataei@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1-Willingness to participate in the study.
2-Have sleep disorders.
3-Suffer from anxiety states.
4-Minimum age for participants 22 and Maximum age 55 years old.
5- Have at least one year of clinical work experience.
6-Have no foot ulcers.</inclusion_criteria>
      <agemin>22 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Taking medication to control sleep problems or anxiety
edema in the foot,
pregnant women</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z56.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Stressful work schedule</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>After grouping and practical training for the intervention group in internal programs, a group of members is formed and an educational video is prepared. Before the start of each session, the video is uploaded and provided to them. Socks are prepared and the individuals wear them. The desired points are marked with a marker and given to the individual. At the end of each week, after 3 sessions (per week), an electronic questionnaire is provided to the participants and completed.</i_keyword>
      <i_keyword>Control group: Only the questionnaire is completed every week without any intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Nurses' sleep quality is measured using the standard Petersburg Sleep Quality Questionnaire. This questionnaire has 7 domains and its final score ranges from 0 to 21, with higher scores indicating worse sleep quality. Timepoint: Questionnaires are completed before the start of the intervention and at the end of every 3 sessions per week (end of each week). Method of measurement: The intervention will consist of 9 reflexology sessions, which will be performed for 3 weeks, 3 sessions per week for each participant. The sessions will be held at home or in a hospital room (as designated) by a previously trained person under the supervision of a relevant expert. Each session will last approximately 15-20 minutes. Data will be collected via an electronic questionnaire at the end of each week after 3 sessions.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Measuring changes in nurses' sleep quality using the total score of the Petersburg Sleep Quality Questionnaire, with higher scores indicating more unfavorable sleep quality. Timepoint: Questionnaires are completed before the start of the intervention and at the end of every 3 sessions per week(end of each week). Method of measurement: The intervention will consist of 9 reflexology sessions, which will be performed for 3 weeks, 3 sessions per week for each participant. The sessions will be held at home or in a hospital room (as designated) by a previously trained person under the supervision of a relevant expert. Eachsession will last approximately 15-20 minutes. Data will be collected via an electronic questionnaire at the end of each week after 3 sessions.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-09-21</approval_date>
        <contact_name>Ethics committee of tehran University of Medical Sciences</contact_name>
        <contact_address>Farabi Hospital,Qazvin Square,Kargar St Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
