<?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>IRCT201211293706N17</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-04-04</date_registration>
      <primary_sponsor>Research deputy of Tabriz university of medical sciences</primary_sponsor>
      <public_title>Effect of Lavender cream with or without foot bath during pregnancy and postpartum on sleep quality and anxiety</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Lavender cream with or without foot bath during pregnancy and postpartum on sleep quality and anxiety: a randomized controlled trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-05-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>129</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/3808</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Other design features: Triple blind only about the intervention II and control groups but not blinded about the interventiongroup III.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: sleep quality in pregnancy AND postparetum. Condition 2: Anxiety in pregnancy and postpartum.</hc_freetext>
      <i_freetext>Intervention 1: Intervention groupI: The participants will rub Lavender creamon their feet once a day about 1 hour before bedtime for the first 8 weeks, as well as for 6 weeks postpartum; they will also immerse legs in 40 to 42 °c water to a depth of 5 cm above the ankle for 10-20 minutes for 8 weeks and will be recommended to continue it until 6 weeks postpartum, if they like. Intervention 2: Intervention groupII: The participants will rub Lavender cream on their feet once a day about an hour before bedtime for the first 8 weeks, as well as for 6 weeks postpartum. Intervention 3: Control group: The participants will get no intervention but will get routine care and instructions like the other groups.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Effati Daryani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kousar Dormitory, South Shariati Ave, Tabriz, Iran</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 44 1225 2309</telephone>
        <email>mahta0608@yahoo.com , effati_f@yahoo.com</email>
        <affiliation>Faculty of Nursing &amp; Midwifery- Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sakineh Mohammad-Alizadeh-Charandabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Midwifery Department, Faculty of Nursing and Midwifery,South Shariati, Tabriz, Post Code: 5138947977, P.O.Box: 51745-347</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41 1477 2699</telephone>
        <email>alizades@tbzmed.ac.ir</email>
        <affiliation>Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: • First to third pregnancy • Gestational age of 25 to 28 weeks • Having a singleton live fetus • Literate • Aged 18 to 45 years • Acquiring Pittsburgh Sleep Quality Index score of 5 or higher. Exclusion criteria: • Having any chronic disease (including diabetes, thyroid disease, preeclampsia, anemia) • Using certain medications • Smoking • History of infertility • Unwanted pregnancy • Allergy to the herbs • Any wounds on the washing and cream rubbing site • Having severe anxiety, depression or stress (Anxiety score above 10, depression score above 14 or stress score above 17 in the DASS-21) • Obesity (BMI above 29) • Having night shift work • No access to phone line.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G47.9</hc_code>
      <hc_code>F41.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sleep disorder, unspecified</hc_keyword>
      <hc_keyword>Generalized anxiety disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention groupI: The participants will rub Lavender creamon their feet once a day about 1 hour before bedtime for the first 8 weeks, as well as for 6 weeks postpartum; they will also immerse legs in 40 to 42 °c water to a depth of 5 cm above the ankle for 10-20 minutes for 8 weeks and will be recommended to continue it until 6 weeks postpartum, if they like.</i_keyword>
      <i_keyword>Intervention groupII: The participants will rub Lavender cream on their feet once a day about an hour before bedtime for the first 8 weeks, as well as for 6 weeks postpartum.</i_keyword>
      <i_keyword>Control group: The participants will get no intervention but will get routine care and instructions like the other groups</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sleep quality score. Timepoint: Before intervention, 4 and 8 weeks after initiation of intervention and 6 weeks after delivery. Method of measurement: Pittsburgh Sleep Quality Index.</prim_outcome>
      <prim_outcome>Anxiety score. Timepoint: At baseline, 4 and 8 weeks after initiation of intervention and 6 weeks after delivery. Method of measurement: DASS-21.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Length of gestation. Timepoint: After delivery. Method of measurement: Using the LMP or resulu of Ultrasound done before 12 weeks of pregnancy and birth date.</sec_outcome>
      <sec_outcome>Birth weight. Timepoint: After delivery. Method of measurement: Weight recorded in the newborn discharge card.</sec_outcome>
      <sec_outcome>Fatigue Score. Timepoint: At baseline, 6 weeks after intervention and 6 weeks after delivery. Method of measurement: Multidimensional Assesment o Fatigue scale (MAF).</sec_outcome>
      <sec_outcome>Score of Stress. Timepoint: At baseline, 4 and 8 weeks after intervention and 6 weeks after delivery. Method of measurement: DASS-21.</sec_outcome>
      <sec_outcome>Score of Depression. Timepoint: At baseline, 4 and 8 weeks after intervention and 6 weeks after delivery. Method of measurement: DASS-21.</sec_outcome>
      <sec_outcome>Score of mother and infant bonding. Timepoint: Six weeks after delivery. Method of measurement: Postpartum Bonding Questionnaire (PBQ).</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Barij Essence Pharmaceutical Company</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Research deputy of Tabriz university of medical sciences</source_name>
      <source_name>Barij Essence Pharmaceutical Company</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-01-21</approval_date>
        <contact_name>Research deputy, Tabriz University of Medical Sciences</contact_name>
        <contact_address>3rd floor, 2nd central building, Golgasht street, Tabriz, Iran Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
