<?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>IRCT20150519022320N23</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-08-08</date_registration>
      <primary_sponsor>Rafsanjan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of aromatherapy with extract salix aegyptiaca on hypertension and quality of sleeping elderly</public_title>
      <acronym></acronym>
      <scientific_title>The effect of aromatherapy with extract salix aegyptiaca on hypertension and quality of sleeping elderly referring to selected health centers of rafsanjan city at 2019</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-06-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49093</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: according to the simple randomization, patients were divided into 35 groups, the intervention group and the control group. Patients were divided into two groups of 35 people, A and B, based on a table of random numbers, and finally, groups A and B were divided into intervention and control groups based on the lottery, Blinding description: In this study, patients and researcher colleague do not aware of the type of group.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Condition 1: Hypertension. Condition 2: Sleep quality.</hc_freetext>
      <i_freetext>Intervention 1: In the intervention group, the extract salix aegyptiaca produced in exir hayat Company with a concentration of 20% is used. The elderly in the intervention group are given a dropper containing  extract salix aegyptiaca  for two weeks. The elderly in the intervention  group undergo aromatherapy at a distance of 5 cm from the nose for 2 minutes and for 2 weeks by inhalation. One day before the intervention, the elderly are explained exactly how to do the plan and the consent form is completed by the elderly and on the same day their blood pressure is measured with a mercury blood pressure monitor and their sleep quality is measured with the Pittsburgh questionnaire..To prevent forgetting the aromatherapy sessions, it is recommended that the elderly perform aromatherapy when performing the morning and evening prayers (morning and evening). Elderly people are asked to take medications for high blood pressure and insomnia within two weeks of the intervention at specific times so that the time of medication does not affect blood pressure and sleep quality. Also, standard conditions for controlling blood pressure include ten minutes of rest before taking blood pressure, inactive physical activity before going to the health center, empty bladder, sitting position evenly and placing the hand on the level of the heart. These cases are registered in the blood pressure registration form before taking the blood pressure. Blood pressure measurement is performed on days 2, 5, 9, 12, and 16 (Mondays, Thursdays, Mondays, Thursdays, and Mondays),  and is followed by ten minutes of rest by a specific person at the clinic. Measurement of sleep quality score is also done after the intervention by completing the sleep questionnaire again. To ensure extract consumption, the exact checklist for aromatherapy is completed by the elderly and delivered to the researcher. Intervention 2: Control group: In the control group, water will be used as a placebo.In the control group, the dropper head is impregnated with extract salix aegyptiaca to disperse some of the smell in the space when opened. This is done in order to continue the cooperation of the elderly in the control group and not to realize that they have a placebo. The elderly in the control group also Will be asked to undergo aromatherapy for 2 minutes twice a day for 2 weeks by inhaling three drops of placebo on cotton at a distance of 5 cm from the nose. In the control group also one day before the intervention, the elderly are explained exactly how to do the plan and the consent form is completed by the elderly and on the same day their blood pressure is measured with a mercury blood pressure monitor and their sleep quality is measured with the Pittsburgh questionnaire. To prevent forgetting the aromatherapy sessions, it is recommended that the elderly perform aromatherapy when performing the morning and evening prayers (morning and evening). Elderly people are asked to take medications for high blood pressure and insomnia within two weeks of the intervention at specific times so that the time of medication does not affect blood pressure and sleep quality. Also, standard conditions for controlling blood pressure include ten minutes of rest before taking blood pressure, inactive physical activity before going to the health center, empty bladder, sitting position evenly and placing the hand on the level of the heart. These cases are registered in the blood pressure registration form before taking the blood pressure.. Blood pressure measurement is performed on days 2, 5, 9, 12, and 16 (Mondays, Thursdays, Mondays, Thursdays, and Mondays), and is followed by ten minutes of rest by a specific person at the clinic. Measurement of sleep quality score is also done after the intervention by completing the sleep questionnaire again. To ensure plasebo consumption, the exact checklist for aromatherapy is completed by the elderly and delivered to the researcher.</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 not more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Tayebeh Mirzaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Parastar Ave.</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7718796755</zip>
        <telephone>+98 34 3452 5900</telephone>
        <email>t.mirzaei@rums.ac.ir</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Tayebeh Mirzaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Geriatric Care Research Center, Jomhoori Eslami Bolv</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7718174715</zip>
        <telephone>+98 34 3425 5900</telephone>
        <email>t.mirzaei@rums.ac.ir</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being 60 years old or older,
The fact that hypertension is detected by Diagnosis of the treating physician and available medical records,
Having primary blood pressure,
Having a sleep disorder based on a score above 5 in the Pittsburgh Questionnaire,
Not having sensitivity to the extract salix aegyptiaca,
Not having sensitivity to the aromatic substances,
Not having a history of allergies or respiratory diseases,
Healthy sense of smell</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>IX 110</hc_code>
      <hc_code>G47.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Essential (primary) hypertension Incl.: High blood pressure</hc_keyword>
      <hc_keyword>Sleep disorder, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the intervention group, the extract salix aegyptiaca produced in exir hayat Company with a concentration of 20% is used. The elderly in the intervention group are given a dropper containing  extract salix aegyptiaca  for two weeks. The elderly in the intervention  group undergo aromatherapy at a distance of 5 cm from the nose for 2 minutes and for 2 weeks by inhalation. One day before the intervention, the elderly are explained exactly how to do the plan and the consent form is completed by the elderly and on the same day their blood pressure is measured with a mercury blood pressure monitor and their sleep quality is measured with the Pittsburgh questionnaire..To prevent forgetting the aromatherapy sessions, it is recommended that the elderly perform aromatherapy when performing the morning and evening prayers (morning and evening). Elderly people are asked to take medications for high blood pressure and insomnia within two weeks of the intervention at specific times so that the time of medication does not affect blood pressure and sleep quality. Also, standard conditions for controlling blood pressure include ten minutes of rest before taking blood pressure, inactive physical activity before going to the health center, empty bladder, sitting position evenly and placing the hand on the level of the heart. These cases are registered in the blood pressure registration form before taking the blood pressure. Blood pressure measurement is performed on days 2, 5, 9, 12, and 16 (Mondays, Thursdays, Mondays, Thursdays, and Mondays),  and is followed by ten minutes of rest by a specific person at the clinic. Measurement of sleep quality score is also done after the intervention by completing the sleep questionnaire again. To ensure extract consumption, the exact checklist for aromatherapy is completed by the elderly and delivered to the researcher.</i_keyword>
      <i_keyword>Control group: In the control group, water will be used as a placebo.In the control group, the dropper head is impregnated with extract salix aegyptiaca to disperse some of the smell in the space when opened. This is done in order to continue the cooperation of the elderly in the control group and not to realize that they have a placebo. The elderly in the control group also Will be asked to undergo aromatherapy for 2 minutes twice a day for 2 weeks by inhaling three drops of placebo on cotton at a distance of 5 cm from the nose. In the control group also one day before the intervention, the elderly are explained exactly how to do the plan and the consent form is completed by the elderly and on the same day their blood pressure is measured with a mercury blood pressure monitor and their sleep quality is measured with the Pittsburgh questionnaire. To prevent forgetting the aromatherapy sessions, it is recommended that the elderly perform aromatherapy when performing the morning and evening prayers (morning and evening). Elderly people are asked to take medications for high blood pressure and insomnia within two weeks of the intervention at specific times so that the time of medication does not affect blood pressure and sleep quality. Also, standard conditions for controlling blood pressure include ten minutes of rest before taking blood pressure, inactive physical activity before going to the health center, empty bladder, sitting position evenly and placing the hand on the level of the heart. These cases are registered in the blood pressure registration form before taking the blood pressure.. Blood pressure measurement is performed on days 2, 5, 9, 12, and 16 (Mondays, Thursdays, Mondays, Thursdays, and Mondays), and is followed by ten minutes of rest by a specific person at the clinic. Measurement of sleep quality score is also done after the intervention by completing the sleep questionnaire again. To ensure plasebo consumption, the exact checklist for aromatherapy is completed by the elderly and delivered to the researcher.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Hypertension. Timepoint: Before the intervention, 2,5,9,12 days after, two days after intervention. Method of measurement: Blood pressure in millimetres of mercury using a Mercury blood pressure.</prim_outcome>
      <prim_outcome>Sleep quality. Timepoint: sleep quality measured in control and intervention groups (before and after the intervention) using the Pittsburgh Sleep Quality Index. Method of measurement: the Pittsburgh Sleep Quality Index.</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>Rafsanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-03-17</approval_date>
        <contact_name>Rafsanjan University of Medical Sciences ethics committee</contact_name>
        <contact_address>School of Nursing and Midwifery, Nurse Avenue, Rafsanjan Rafsanjan Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
