<?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>IRCT20220119053760N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-12-04</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>The relationship between sleep hygiene and blood pressure control</public_title>
      <acronym></acronym>
      <scientific_title>The effect of sleep hygiene training on sleep quality and blood pressure in patients with blood pressure and sleep disorders</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-04-18</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>86</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73669</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: First, among the clients of Ibn Sina Center in Isfahan city, 86 clients who had high blood pressure (≥140/90) and had a medical record in the center were selected and included in the study. Patients eligible to enter the study received a code in order of entry (from number 1 to number 86), then using these codes and using SPSS software, they were assigned to two groups of 43 people, intervention and control (spss/data/ selected cases). Allocation of patients into two intervention and control groups was done in a simple random manner. The study was not blinded. The randomization unit is individual.</study_design>
      <phase>2-3</phase>
      <hc_freetext>blood pressure.</hc_freetext>
      <i_freetext>Intervention 1: 43 patients with high blood pressure were trained as follows during four training sessions of 60-75 minutes:  Session 1: Defining sleep and explaining the mechanism of sleep and wakefulness, presenting materials related to relaxation techniques to enter a peaceful and pleasant sleep in accordance with the principles of sleep hygiene.Session 2: Explaining the relationship between sleep and blood pressure, examining physiological changes in sleep and sleep disorders in simple language, explaining and interpreting 10 principles of sleep hygiene.  Session 3: Investigating the effect of age on sleep, introducing the components of sleep and a brief explanation regarding factors that disrupt sleep (such as sound, light, etc.) and improve it (earmuffs, blindfolds, dark and silent places, etc.) ), explanation and interpretation of 13 items from the principles of sleep hygiene.  Session 4: Summarizing and reviewing the trainings of the previous sessions and the necessity of adhering to the application of the taught items and timely referrals at one-month and three-month intervals to measure blood pressure and complete the Petersburg Sleep Quality Questionnaire.The educational method included lectures, questions and answers, and discussions in small groups.The sleep quality assessment method was through the Pittsburgh Sleep Quality Index, which was completed before, one month, and three months after the completion of the training. The Petersburg Sleep Quality Questionnaire is a report that examines sleep quality over the past month. This questionnaire has 19 questions with 4 options and contains 9 sections to examine the dimensions of mental quality of sleep, delay in falling asleep, sleep duration, sleep efficiency, sleep disorders, use of sleeping pills, daily dysfunction. Intervention 2: Control group: They did not receive any training intervention. Their blood pressure was measured before, one month and three months after completing the training. The Pittsburgh Sleep Quality Questionnaire was also completed before, one month and three months after the completion of the training.</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 can be shared after de-identification, 6 months after publication of the article.

When:
Information can be shared 6 months after the publication of the article.

To whom:
physicians

Conditions:
The information of this study can be used by doctors, internal specialists, endocrinologists, psychologists and researchers in the field of non-pharmacological interventions. In this regard, if researchers consider comparing another educational or therapeutic method with the present method, or if they examine the sample of patients other than those with blood pressure but with sleep disorders, they can benefit from the results of our study.

Where to obtain:
Send email to:
golshiri@hlth.mui.ac.ir
Belongs to Dr. Prasto Golshiri, Faculty of Medicine, Isfahan University of Medical Sciences.

How to obtain:
Send email to:
golshiri@hlth.mui.ac.ir

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Neda Abrishami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan University of Medical Sciences, School of Medicine</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81746-73461</zip>
        <telephone>+98 31 3778 8089</telephone>
        <email>n.abrishami@hlth.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Neda Abrishami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan University of Medical Sciences, School of Medicine</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81746-73461</zip>
        <telephone>+98 31 3778 8089</telephone>
        <email>n.abrishami@hlth.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patient consent to enter the study
Age range from 30 to 70 years
Patients who, according to the latest guidelines of the Ministry of Health and Medicine, have been diagnosed with high blood pressure or had uncontrolled blood pressure (blood pressure ≤ 90.140 mmHg) despite taking medication.</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Severe physical or mental illness
addiction
pregnancy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R03</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Abnormal blood-pressure reading, without diagnosis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>43 patients with high blood pressure were trained as follows during four training sessions of 60-75 minutes:  Session 1: Defining sleep and explaining the mechanism of sleep and wakefulness, presenting materials related to relaxation techniques to enter a peaceful and pleasant sleep in accordance with the principles of sleep hygiene.Session 2: Explaining the relationship between sleep and blood pressure, examining physiological changes in sleep and sleep disorders in simple language, explaining and interpreting 10 principles of sleep hygiene.  Session 3: Investigating the effect of age on sleep, introducing the components of sleep and a brief explanation regarding factors that disrupt sleep (such as sound, light, etc.) and improve it (earmuffs, blindfolds, dark and silent places, etc.) ), explanation and interpretation of 13 items from the principles of sleep hygiene.  Session 4: Summarizing and reviewing the trainings of the previous sessions and the necessity of adhering to the application of the taught items and timely referrals at one-month and three-month intervals to measure blood pressure and complete the Petersburg Sleep Quality Questionnaire.The educational method included lectures, questions and answers, and discussions in small groups.The sleep quality assessment method was through the Pittsburgh Sleep Quality Index, which was completed before, one month, and three months after the completion of the training. The Petersburg Sleep Quality Questionnaire is a report that examines sleep quality over the past month. This questionnaire has 19 questions with 4 options and contains 9 sections to examine the dimensions of mental quality of sleep, delay in falling asleep, sleep duration, sleep efficiency, sleep disorders, use of sleeping pills, daily dysfunction.</i_keyword>
      <i_keyword>Control group: They did not receive any training intervention. Their blood pressure was measured before, one month and three months after completing the training. The Pittsburgh Sleep Quality Questionnaire was also completed before, one month and three months after the completion of the training.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sleep quality. Timepoint: before, one month and three months after the end of the intervention. Method of measurement: Pittsburgh Sleep Quality Index (PSQI).</prim_outcome>
      <prim_outcome>Blood pressure. Timepoint: before, one month and three months after the end of the intervention. Method of measurement: With the help of a mercury pressure gauge.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-07-23</approval_date>
        <contact_name>Ethics committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Isfahan University of Medical Sciences , Hezar Jerib St. Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
