<?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>IRCT20220706055397N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-06</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>Comparison the Effect of Mindfulness Therapy and Aromatherapy with Lavender Essential Oil  on Quality of Sleep in Post-Partum Women</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the Effect of Mindfulness Therapy and Aromatherapy with Lavender Essential Oil  on Quality of Sleep in Post-Partum Women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-05-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>132</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64637</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: First, we determine the names and surnames of 132 qualified people who are registered in the above hospital, code them from 1 to 132, and then enter the codes of the people in the SPSS software and use that software. The software that gives us the possibility of simple random selection, we perform a simple random selection and put the subjects under study in each of the groups. For this purpose, after running the random sample of cases, a new column was created in the data whose code 1 indicates the selection for the mindfulness group. Then we delete the selected people of the mindfulness group and execute the command again on other people, and put the code of a new column in the aromatherapy group. The remaining people, who will be coded zero, will be included in the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Postpartum care.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: َ Aromatherapy with lavender with a volume of 15 ml, which is poured on a napkin between two drops of this oil one night for two months, and is inhaled by people for ten minutes before going to bed. Intervention 2: Intervention group: Mindfulness counseling group in the form of counseling on WhatsApp for 8 one-hour sessions. Intervention 3: Control group: For this group, routine postpartum care, which included breastfeeding, mental health, physical and sexual education, was given by the researcher in a virtual way and in audio and written files. In this group, no counseling was given regarding the improvement of sleep quality.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is We must share with Arak university of medical sciences</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Ghalegar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khalije-Fars.Arak university of medical sciences,Arak</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3848176941</zip>
        <telephone>+98 86 3417 3505</telephone>
        <email>zahra.ghalgar.74@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Ghalegar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khalije-Fars.Arak university of medical sciences,Arak</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3848176941</zip>
        <telephone>+98 86 3417 3506</telephone>
        <email>zahra.ghalgar.74@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Mothers who passed  no more than 2 weeks  since their delivery
Pittsburgh Sleep Questionnaire score above 5 
Not using complementary medicine or psychological counseling during the last six months
Lack of underlying disease
Lack of pulmonary and respiratory problems such as asthma
Having minimum  level of reading and writing literacy and mastering the WhatsApp application
Access to the Internet and WhatsApp application</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Use of complementary medicine or psychological counseling during the past six months
The presence of an underlying disease
The presence of lung and breathing problems such as asthma
Mother's lack of interest in participating in the research
The presence of any problems in the postpartum process, such as the mother or baby being unwell and losing the family
Discomfort and dissatisfaction with the smell of fragrances
Allergy to lavender</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z39.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Encounter for routine postpartum follow-up</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: َ Aromatherapy with lavender with a volume of 15 ml, which is poured on a napkin between two drops of this oil one night for two months, and is inhaled by people for ten minutes before going to bed.</i_keyword>
      <i_keyword>Intervention group: Mindfulness counseling group in the form of counseling on WhatsApp for 8 one-hour sessions</i_keyword>
      <i_keyword>Control group: For this group, routine postpartum care, which included breastfeeding, mental health, physical and sexual education, was given by the researcher in a virtual way and in audio and written files. In this group, no counseling was given regarding the improvement of sleep quality.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pittsburgh Sleep Questionnaire score. Timepoint: The sleep score was evaluated at the beginning of the and at the end of the study (8 weeks after the beginning of the study) in 3 groups: mindfulness, aromatherapy with lavender, and the control group. Method of measurement: Pittsburgh Sleep Questionnaire.</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>Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-05-15</approval_date>
        <contact_name>Ethics Arak University of Medical Sciences</contact_name>
        <contact_address>Khalige Fars Ave,Arak University of Medical Sciences,Arak town Arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
