<?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>IRCT20191127045524N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-06</date_registration>
      <primary_sponsor>Shahroud University of Medical Sciences</primary_sponsor>
      <public_title>Effectiveness Progressive Relaxation on Blood Pressure and Worry In The Elderly</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of Progressive Relaxation Technique on Blood Pressure and Worry among Aged People With Blood Pressure : A Parallel Randomized Clinical Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-06-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/44149</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The random allocation sequence and block list will be obtained by the software consultant with the help of the software. The https://www.sealedenvelope.com website is a useful site for generating random sequences for block randomization. This site is designed so that there is no limit to the number of groups to be assigned randomly. The four-volume block method is used with spss software to generate random allocation sequences. Patients will be selected according to the researcher's criteria and will be randomly divided into two groups (intervention) and group B (control group). Randomization will be done in secret. This means that there are 100 envelopes packed in A and B code each. After obtaining informed consent and determining that the individual is participating in the study, the researcher picks up the envelope in the specified order and proceeds according to the envelope group recorded.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Blood Pressure And Worry.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:The research community includes all the elderly who refer to the blood pressure clinic of the specialized clinic of Imam Hossein Hospital in 1399. After selection, individuals will be assigned to both test and control groups based on entry criteria. First, the MMSE (Mini-Mental State Examination) and ADL (Activity of Daily Living) and GD5-15 (Geriatric Depression Scale-15) questionnaires are completed for individuals, and then the concern questionnaire confirming the presence of the problem in individuals and so on. Blood pressure testing, which is performed at elevated levels and levels 1 and 2 as defined by the American Heart AHA (Association), is performed on individuals in the Jacobson Intervention Group. After selecting the test group members based on the criteria for entering and obtaining informed consent, they are trained in the same blood pressure clinic. The subjects of the test group are divided into four groups of 10 people and all groups are taught separately by the researcher in one session in the blood pressure clinic. A 60-minute session will explain the research objectives, blood pressure, and Worry and relaxation techniques. At the end of the session, how to implement the advanced relaxation technique and independent implementation of patients to ensure the correct implementation of the technique will be done. Also, at the end of the training phase, the research units will have a booklet that includes division of blood pressure levels and correct blood pressure measurement. According to the American Heart Association, progressive relaxation techniques are given. After the training, it is done in such a way that the members of the test group perform the technique they have been trained in at home for 20 to 30 minutes a day in the morning (7 to 8) and in the afternoon (4 to 5). Once a week, in order to follow up on the technique and the process of doing the work and the technique of the test group members, they refer to the medical service centers that are covered so that the person trained by the researcher monitors the work process of the test group members. A blood pressure monitor checks all test group members. This is done continuously for up to 4 weeks, and the test group and control group are again asked to be assessed by the Worry and blood pressure measurement questionnaire. The technique is to first close the eyes. And as much as possible, they are in a relaxed state and focus all their attention on their breathing. They take five deep breaths and slowly empty. At the same time, they think of peace, liberation, and weakness in their minds. After this stage, patients should contract and expand the muscle for 14 muscle groups, respectively, including the facial muscles (forehead, eyelids, jaw, lips), neck muscles, fingers, palms, forearms, arms, shoulders, back, waist, chest. , Abdomen, sitting, thighs, legs, feet, soles of the feet, do. It takes 5 seconds for each muscle to contract and 10 seconds for it to expand. Also, when the muscles contract, they should not tighten too much and put pressure on themselves. Finally, relax your whole body and take 5 deep breaths, slowly open your eyes and return to normal. For the group, the routine care control center is provided to control blood pressure and reduce Worry. Intervention 2: Control group: People with high blood pressure and worry who go to the blood pressure clinic are the specialized clinic of Imam Hossein Hospital, which receives the center's routine care, and at the end of the study, the educational booklet is provided to patients.</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:
Part of the patient's demographic information is shared after people have not been identified. All information related to measuring worry and blood pressure in patients can be shared after people have not been identified.

When:
Access started in September 1399

To whom:
Researchers and students of academic and scientific institutions

Conditions:
Raw data for correlation studies

Where to obtain:
amirheidar770@yahoo.com

How to obtain:
Clear explanation of the reason for the need to access data and provide data after two weeks

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>AmirHeidar Bakhshi Arab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 24, Alley 3, Kharghani Street, Shahroud Town</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3613698563</zip>
        <telephone>+98 23 3222 4816</telephone>
        <email>amirheidar770@yahoo.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Dadgari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>7th Square, Shahroud University of Medical Sciences, School of Nursing and Midwifery, Shahroud Town</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3614773947</zip>
        <telephone>+98 23 3239 3811</telephone>
        <email>adadgari@yahoo.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>60 years and older
Understanding and speaking Persian language
Being at elevated levels and levels 1 and 2 blood pressure
Cognitive ability is shortened based on cognitive status testing Mini-Mental State Examination (MMSE) test results
Earn individual independence scores on daily life activities Activity of Daily Livivng (ADL) test</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Use sedatives over the past 1 week
Using previous relaxation techniques in the last 6 months
Having a depressive background based on a test of 15 questions of depression in the elderly Geriatric Depression Scale-15      (GDS-15) test</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z01.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Encounter for examination of blood pressure</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:The research community includes all the elderly who refer to the blood pressure clinic of the specialized clinic of Imam Hossein Hospital in 1399. After selection, individuals will be assigned to both test and control groups based on entry criteria. First, the MMSE (Mini-Mental State Examination) and ADL (Activity of Daily Living) and GD5-15 (Geriatric Depression Scale-15) questionnaires are completed for individuals, and then the concern questionnaire confirming the presence of the problem in individuals and so on. Blood pressure testing, which is performed at elevated levels and levels 1 and 2 as defined by the American Heart AHA (Association), is performed on individuals in the Jacobson Intervention Group. After selecting the test group members based on the criteria for entering and obtaining informed consent, they are trained in the same blood pressure clinic. The subjects of the test group are divided into four groups of 10 people and all groups are taught separately by the researcher in one session in the blood pressure clinic. A 60-minute session will explain the research objectives, blood pressure, and Worry and relaxation techniques. At the end of the session, how to implement the advanced relaxation technique and independent implementation of patients to ensure the correct implementation of the technique will be done. Also, at the end of the training phase, the research units will have a booklet that includes division of blood pressure levels and correct blood pressure measurement. According to the American Heart Association, progressive relaxation techniques are given. After the training, it is done in such a way that the members of the test group perform the technique they have been trained in at home for 20 to 30 minutes a day in the morning (7 to 8) and in the afternoon (4 to 5). Once a week, in order to follow up on the technique and the process of doing the work and the technique of the test group members, they refer to the medical service centers that are covered so that the person trained by the researcher monitors the work process of the test group members. A blood pressure monitor checks all test group members. This is done continuously for up to 4 weeks, and the test group and control group are again asked to be assessed by the Worry and blood pressure measurement questionnaire. The technique is to first close the eyes. And as much as possible, they are in a relaxed state and focus all their attention on their breathing. They take five deep breaths and slowly empty. At the same time, they think of peace, liberation, and weakness in their minds. After this stage, patients should contract and expand the muscle for 14 muscle groups, respectively, including the facial muscles (forehead, eyelids, jaw, lips), neck muscles, fingers, palms, forearms, arms, shoulders, back, waist, chest. , Abdomen, sitting, thighs, legs, feet, soles of the feet, do. It takes 5 seconds for each muscle to contract and 10 seconds for it to expand. Also, when the muscles contract, they should not tighten too much and put pressure on themselves. Finally, relax your whole body and take 5 deep breaths, slowly open your eyes and return to normal. For the group, the routine care control center is provided to control blood pressure and reduce Worry.</i_keyword>
      <i_keyword>Control group: People with high blood pressure and worry who go to the blood pressure clinic are the specialized clinic of Imam Hossein Hospital, which receives the center's routine care, and at the end of the study, the educational booklet is provided to patients.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Examine the blood pressure level of people with a blood pressure monitor (ALPK2) that is calibrated before starting the procedure and also calibrated on a specific day each week. In this study, people with high blood pressure and blood pressure levels 1 and 2 entered the study according to the American Heart Association. Timepoint: At the beginning of the study (before the start of the intervention) and 4 weeks after the intervention. Method of measurement: By the ALPK2 hand blood pressure monitor, which is calibrated before starting the procedure, and also calibrated on a specific day each week.</prim_outcome>
      <prim_outcome>Worry studies in people with high blood pressure are assessed through the Pennsylvania Concern Questionnaire. The range of scores for the questionnaire ranges from 16 to 80. The score is between 16 and 32: The severity of worry is low. Between 32 and 48: The severity of worry is moderate. Timepoint: At the beginning of the study (before the start of the intervention) and 4 weeks after the intervention. Method of measurement: Pennsylvania Concerns Questionnaire. The scope of the questionnaire scores is from 16 to 80. Score between 16 and 32: The severity of worry is low. The score is between 32 and 48: The severity of worry is moderate.</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>Shahroud University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-05-09</approval_date>
        <contact_name>Ethics Committee in Research of Shahroud University of Medical Sciences</contact_name>
        <contact_address>7th Square, Research and Technology, Shahroud University of Medical Science, Shahroud Town Shahroud Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
