<?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>IRCT20100919004775N12</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-10-31</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Benson relaxation on sleep quality and quality of working life</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Benson relaxation on sleep quality and quality of work life of operating room staff</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>180</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/41840</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Education/Guidance, Randomization description: Specify sample size:
Sample size was randomly assigned using NCSS software with 80% power, 5% type I error, and using similar data (24), mean and standard deviation, in control group (32) and intervention group (95%). / 52) 90 persons were assigned to each group.
        
How to choose a sample:
First, with a coin and the use of a toss, we specify that the numbers 1 to 90 (the first 90) fall into the intervention group and the numbers 91 to 180 (the second 90) into the control group. The number of cards will be numbered from one to 180 and will be distributed among those who meet the criteria for admission to the study. Based on the number of operating room staff in each hospital, we determine in advance how many numbers are to be assigned to each hospital and then enter the intervention group as the numbers that emerge. To compensate for the loss, the number of intervention and control groups will be greater than 90 each.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Work life quality.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group: Operating room personnel with bachelor's, associate's and master's degree, obtained a score of less than or equal to 5 by the Pittsburgh Questionnaire and a mean score (56-88) and a low score (24-55) by the Quality of Work Questionnaire. They practice Benson relaxation for 2 months. After that, they receive the questionnaires again and calculate their effects by calculating their scores. Intervention 2: Control group: Operating room personnel with a bachelor's, associate's, and master's degree, earned a score of less than or equal to 5 using the Pittsburgh Questionnaire and a moderate (56-88) and a low (24-55) quality of work life questionnaire. They do not practice Benson relaxation for 2 months and during this time they do not take any traditional or traditional sedatives.</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:
Information on the impact of the secondary outcome on the primary outcome is published.

When:
One year after the results were published

To whom:
Research participants and hospitals

Conditions:
To the participants if they remain in the research until the last stage

Where to obtain:
Phone 09386688127 or email Maryam Ghavnati.
technologist96@gmail.com

How to obtain:
Requesting the above email will request the results of the research.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Ghanavati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Eram</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7194685791</zip>
        <telephone>+98 71 3628 2700</telephone>
        <email>Technologist96@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>maryam ghanavati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>eram</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7194685791</zip>
        <telephone>+98 71 3628 2700</telephone>
        <email>technologist96@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Minimum of associate's degree or bachelor's degree in practice room Personnel
Willing to participate in research
Have not used hypnotic drugs in the past month</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: Operating room personnel with bachelor's, associate's and master's degree, obtained a score of less than or equal to 5 by the Pittsburgh Questionnaire and a mean score (56-88) and a low score (24-55) by the Quality of Work Questionnaire. They practice Benson relaxation for 2 months. After that, they receive the questionnaires again and calculate their effects by calculating their scores.</i_keyword>
      <i_keyword>Control group: Operating room personnel with a bachelor's, associate's, and master's degree, earned a score of less than or equal to 5 using the Pittsburgh Questionnaire and a moderate (56-88) and a low (24-55) quality of work life questionnaire. They do not practice Benson relaxation for 2 months and during this time they do not take any traditional or traditional sedatives.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sleep Quality: A state of sleep that can be defined as its effect on the amount of fatigue during waking up during the day or the feeling of being happy and well after waking up and the number of waking up at night. Sleep quality, sedentary sleep, feeling of well-being and well-being after waking up in operating room personnel during the intervention were measured before and after the intervention using the Pittsburgh Sleep Quality Assessment Tool. In this study, operating room personnel will be recruited based on the scale of the questionnaire if they score less than or equal to 5. Timepoint: Before the intervention and 2 months after the intervention. Method of measurement: Pittsburgh Sleep Quality Questionnaire.</prim_outcome>
      <prim_outcome>Quality of Work Life: How much one feels and understands the physical and psychological state of their workplace. In this study, quality of work life is a score obtained by operating room personnel. What improves it is to increase hospital productivity. Before and after the intervention, Walton measured the quality of work life. In this study, operating room staff will be recruited based on the scale of the questionnaire if they score moderate (56-88) and low (24-55) on the quality of working life. Timepoint: before the intervention and 2 months after the invention. Method of measurement: Waltons questionnair.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Benson Relaxation Intervention: Relaxation is a state in which one's stress is at a low level and emotional levels, especially anxiety, fear and anger, are reduced. The process used to create this condition is called relaxation or relaxation. In a specific sense, the return of a contracted muscle back to its original state of relaxation is the purpose of this study of relaxation, a method introduced by Herbert Benson in 1970 and performed in four stages: 1. Providing a relaxed environment. Being in a comfortable state of mind3- Creating a mental focus 4- Creating a passive state of sampling The subjects are asked to do it twice a day for 20 minutes each time for 4 weeks. Timepoint: During the intervention for 2 months. Method of measurement: Pittsburgh Sleep Quality Questionnaire and Walton Quality of Work Life Questionnaire.</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>Shiraz University medical sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-08-28</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Eram. khabgah Eram6 Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
