<?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>IRCT20210808052111N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-09-04</date_registration>
      <primary_sponsor>Artesh University of Medical Sciences</primary_sponsor>
      <public_title>The effect of progressive muscle relaxation training with demonstration methods on the level of stress, anxiety and depression</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation the effect of progressive muscle relaxation training with demonstration method on the level of stress, anxiety and depression of nurses encountering of COVID-19</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-09-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>46</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58007</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The sampling method will initially be available; the samples will then be placed in quadruple blocks by block random sampling. The size of all blocks is equal and in this two-group Clinical Trial, we will have blocks of size 4 (including 2 people participating in the intervention group and 2 people participating in the control group). Random allocation software is also used for randomization tools. For hiding, allocation concealment is used, which is the method used to execute a random sequence on the study participants, so that the assigned group is not known before the person is assigned. Using opaque envelopes sealed with random sequences (Sequentially numbered, sealed, opaque envelopes) in which in this method each of the random sequences created is recorded on a card and the cards are placed in the envelopes in order. In order to keep up a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the envelopes will be closed and placed inside a box. At the beginning of the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes is opened in order and the assigned group of the participant is revealed.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: stress. Condition 2: Anxiety. Condition 3: depression.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention group will perform Jacobson's progressive muscle relaxation technique for 2 weeks, once a day for 20 minutes each time at home. The practical demonstration of a progressive muscle relaxation technique is performed and taught by the researcher himself in the hospital amphitheater during two 60-minute sessions (Every other day). The first session will be a practical demonstration of how to relax and the second session will be a repetition of the first session in order to consolidate the training. At the end of the training sessions, the video of that session will be given to the test group to act only according to the training they have received in practice. The progressive muscle relaxation technique taught will be such that the nurse is sitting or lying in a comfortable chair. Preferably, the subjects' clothes are loose and the watch takes off its bracelet. Then, with the guidance of the instructor and by listening to the audiotape, he contracts and relaxes different muscle groups along with effective and deep breathing. In this technique, large muscle groups are first contracted and relaxed; Because the contraction and relaxation of these muscles and understanding the difference between these two feelings at the beginning of the work is more tangible for people. When the participant contracts and relaxes each of his muscles, he is able to easily and spontaneously relax his whole body in the way he has learned, and from anxiety, stress, and any unpleasant mental, psychological and physical feelings. Clear. Intervention 2: Control group: No special intervention will be performed in this group.</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 no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Samaneh Ganjeali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kaj Street, in front of Baharshiraz Street, Shariati Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>16151116139</zip>
        <telephone>+98 21 7750 0929</telephone>
        <email>samaneganjeali@yahoo.com</email>
        <affiliation>Artesh University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Farsi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kaj Street, in front of Baharshiraz Street, Shariati Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1615116139</zip>
        <telephone>+98 21 7750 0929</telephone>
        <email>Zahrafarsi@gmail.com</email>
        <affiliation>Artesh University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Have at least a bachelor's degree in nursing
Has at least six months of clinical experience</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Taking anti-anxiety and psychoactive drugs
History of previous training in Jacobson relaxation technique
Crisis experience by participants in the study during the last 6 months</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z56.3</hc_code>
      <hc_code>F40</hc_code>
      <hc_code>F32.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Stressful work schedule</hc_keyword>
      <hc_keyword>Phobic anxiety disorders</hc_keyword>
      <hc_keyword>Major depressive disorder, single episode, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention group will perform Jacobson's progressive muscle relaxation technique for 2 weeks, once a day for 20 minutes each time at home. The practical demonstration of a progressive muscle relaxation technique is performed and taught by the researcher himself in the hospital amphitheater during two 60-minute sessions (Every other day). The first session will be a practical demonstration of how to relax and the second session will be a repetition of the first session in order to consolidate the training. At the end of the training sessions, the video of that session will be given to the test group to act only according to the training they have received in practice. The progressive muscle relaxation technique taught will be such that the nurse is sitting or lying in a comfortable chair. Preferably, the subjects' clothes are loose and the watch takes off its bracelet. Then, with the guidance of the instructor and by listening to the audiotape, he contracts and relaxes different muscle groups along with effective and deep breathing. In this technique, large muscle groups are first contracted and relaxed; Because the contraction and relaxation of these muscles and understanding the difference between these two feelings at the beginning of the work is more tangible for people. When the participant contracts and relaxes each of his muscles, he is able to easily and spontaneously relax his whole body in the way he has learned, and from anxiety, stress, and any unpleasant mental, psychological and physical feelings. Clear</i_keyword>
      <i_keyword>Control group: No special intervention will be performed in this group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Stress. Timepoint: Before and one month after the intervention. Method of measurement: DASS-21 questionnaire.</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: Before and one month after the intervention. Method of measurement: DASS-21 questionnaire.</prim_outcome>
      <prim_outcome>Depression. Timepoint: Before and one month after the intervention. Method of measurement: DASS-21 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>Artesh University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-06-01</approval_date>
        <contact_name>Ethics committee of Aja University of Medical Sciences</contact_name>
        <contact_address>Etemadzadeh Street, West Fatemi Street, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
