<?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>IRCT20191208045659N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-01-27</date_registration>
      <primary_sponsor>Semnan University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the Effect of Spiritual Care and Aromatherapy on Anxiety and Sleep Pattern of Emergency referrers to Prison Clinic</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of spiritual care and aromatherapy on anxiety and sleep patterns of emergency referrers to Korsestan province prisons clinics</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-01-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/44688</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The samples are divided into three groups by simple random method. The groups are separated by giving them a random code, such as number one for group 1 (spiritual care with aromatherapy) and number two for group 2 (spiritual care) and number 2. Three will be performed for group 3 (control group).</study_design>
      <phase>3</phase>
      <hc_freetext>Anxiety and stress.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: group 1, 2 drops of lavender extract will be impregnated with 2 x 2 gas and attached to the prisoners' collar. This aromatherapy treatment was performed for 20 minutes inmates in 3 intermittent 5-day phases with spiritual care. Aromatherapy for the third stage is using a fumigation machine containing 2 liters of water and 20 drops of lavender extract. Intervention 2: Intervention group: In group, 2 interventions included providing  short texts of the Holy Qur'an that emphasized patience and prayer. It should be explained that the main focus is on the 10 verses of the Holy Quran (which have been recommended for patience and prayer). In addition, the beautiful text of the above verses will be provided to the participants and, if possible, an audio file containing the above verses will be provided. Next, two storybooks, one related to the above verses and the other a short story about patience and restraint, will be provided. In the research process, participants will be encouraged to share the story with others. To do this, meetings will be held in limited groups (about 3 to 5 people) if the conditions for spiritual intervention (reading the Quran and story) are available. It should be noted that the 3-step intervention mentioned will be performed in 3 alternate 5-day stages (couple or individual) for each of the mentioned samples. The mentioned intervention is provided for about 20 minutes under the guidance of the researcher and with the assistance of the prison cultural representatives, for each of the sample inmates at approximately 7-9 pm. Intervention 3: Control group: Group 3 (control group) receives only routine care in prison.</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 Because of their presence in prison</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Milad Abdul Maleki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Damghan Road, Semnan University of Medical Sciences</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3514993437</zip>
        <telephone>+98 23 3365 4170</telephone>
        <email>abdolmalakim@yahoo.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hassan Babam Mohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Damghan Road, Semnan University of Medical Sciences</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3514993437</zip>
        <telephone>+98 23 3365 4170</telephone>
        <email>babamohammady2007@gmail.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Men residing in prisons in Kurdistan province
Adequate literate, physically and mentally capable to answer the questions
No Mental Illness (Based on Documentation or Doctor's Approval)
No record of criminal problems such as murder
No history of allergies and respiratory diseases, according to the patient
No previous record of being in prison more than once</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>60 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>History of receiving painkillers and narcotic drugs 24 hours in advance
Prisoners with olfactory problems
Anxiety score less than 31 (mild anxiety)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F06.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Anxiety disorder due to known physiological condition</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: group 1, 2 drops of lavender extract will be impregnated with 2 x 2 gas and attached to the prisoners' collar. This aromatherapy treatment was performed for 20 minutes inmates in 3 intermittent 5-day phases with spiritual care. Aromatherapy for the third stage is using a fumigation machine containing 2 liters of water and 20 drops of lavender extract.</i_keyword>
      <i_keyword>Intervention group: In group, 2 interventions included providing  short texts of the Holy Qur'an that emphasized patience and prayer. It should be explained that the main focus is on the 10 verses of the Holy Quran (which have been recommended for patience and prayer). In addition, the beautiful text of the above verses will be provided to the participants and, if possible, an audio file containing the above verses will be provided. Next, two storybooks, one related to the above verses and the other a short story about patience and restraint, will be provided. In the research process, participants will be encouraged to share the story with others. To do this, meetings will be held in limited groups (about 3 to 5 people) if the conditions for spiritual intervention (reading the Quran and story) are available. It should be noted that the 3-step intervention mentioned will be performed in 3 alternate 5-day stages (couple or individual) for each of the mentioned samples. The mentioned intervention is provided for about 20 minutes under the guidance of the researcher and with the assistance of the prison cultural representatives, for each of the sample inmates at approximately 7-9 pm.</i_keyword>
      <i_keyword>Control group: Group 3 (control group) receives only routine care in prison</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety. Timepoint: Anxiety will be measured three times before, immediately and one month after the intervention. Method of measurement: Anxiety will be measured by using the Spielberger Anxiety Inventory.</prim_outcome>
      <prim_outcome>The sleep patterns. Timepoint: The sleep patterns of the study samples will be measured three times before, immediately before and one month after the intervention. Method of measurement: The sleep patterns of the study samples will be measured by using of the Pittsburgh Sleep Quality 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>Semnan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-12-16</approval_date>
        <contact_name>The aforementioned proposal was submitted by the Forty-fourth Century Ethics Committee Of Semnan Uni</contact_name>
        <contact_address>Semnan University of Medical Sciences, Damghan Road, Semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
