<?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>IRCT20170617034592N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-03-02</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Guided imagery and progressive muscle relaxation on sedation of non invasive mechanically ventilated patients</public_title>
      <acronym></acronym>
      <scientific_title>Effect of guided imagery and progressive muscle relaxation on sedation of non invasive mechanically ventilated patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62103</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Available sampling method will be used for sampling. Then, patients with Covid 19 will be placed under non-invasive mechanical ventilation in the intensive care unit with inclusion criteria, alternately using a simple random method in the interventional and control groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Covid-19 patients.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Before performing the intervention, after explaining the objectives of the study, informed consent will be obtained from the patients of the intervention group and in order to observe research ethics, they will be assured about the confidentiality of information and the possibility of leaving the study at any stage. The intervention will be performed on patients in this group. Prior to the intervention, demographic questionnaires, physiological criteria and Adaptation to the intensive care environment (ATICE), new sedation assessment instrument will be completed. In this group, in addition to routine care, the intervention will be an explanation of the goals of guided imagery and progressive muscle relaxation , an explanation of the positive effects and usefulness of this method, based on the article by Ghaffari et al. (2007), guided imagery and progressive muscle relaxation  as a non-pharmacological treatment will be held individually for 4 days a week for 30 minutes every other day. The researcher will be present at each patient's bedside and will teach guided imagery and progressive muscle relaxation techniques. In this way, in the evening shift, when the ward is quieter and environmental stimuli such as noise and commuting caused by visits are less, he is present in the intensive care unit and is present at each patient's bedside and tells the patient about guided imagery and progressive muscle relaxation. guided imagery and progressive muscle relaxation are often used together because visualization can enhance the relaxation process and enhance its effect. This method is one of the components of cognitive-behavioral therapy that is designed to reduce stress and anxiety through muscle relaxation. In the first session, regarding the goals and stages of the training program, theoretical foundations related to the guided imagery and progressive muscle relaxation technique, introducing muscles and muscle groups, training on how and steps to perform the relaxation technique along with guided imaging and the time of relaxation technique. Will be trained. During the second to fourth sessions to start the exercises, for physical relaxation, the patient is asked to be in the supine position, after a few deep breaths of the abdomen and diaphragm with the eyes closed and comfortable, in the best position in which he feels relaxed. In the first 20 minutes of the session, relaxation exercises will be performed, during which the mind will focus on the contraction of the muscles of different parts of the body and then their rest. Relaxation exercises for 8 muscle groups including arm muscles, upper arm muscles, shoulder and neck muscles, back and shoulder muscles, facial muscles, chest muscles involved in the process of breathing exercises, abdominal muscles, muscles The first step is to consciously relieve tension on the muscles, and in the final 10 minutes of the session, guided imagery with a focus on depicting a desirable scene and custom (forest, beach, religious places, hospital discharge and presence with family, reducing the need for oxygen therapy and comfortable breathing ...) will be done. During the imaging, the patient will visualize a scene in which he feels safe and free from tension and anxiety, and with the voice of the researcher, the imaging is done for the patient and the patient enters a pleasant atmosphere that is his favorite. In general, people are encouraged to take deep abdominal and diaphragmatic breaths and then combine muscle release with depictions of landscapes such as forests, the beach, or places of pilgrimage. Progressive muscle relaxation and visualization are often used together because visualization can enhance the relaxation process and increase its effectiveness. The patient will perform sedation technique under the supervision of the researcher and feedback will be taken from the patient after each session. Before the start of each session, the researcher will answer patients' possible questions about the relaxation technique and feedback on the positive experiences of the previous session. Patients' physiological criteria will also be recorded before and after each relaxation session. At the end of the session, patients are asked to write down the number of times they do relaxation exercises and guided imagery. Finally, after the end of the fourth session, the information of this group will be collected using questionnaires and will be analyzed according to the goals of the study. Intervention 2: Control group:  informed consent will be obtained from the patients of the control group and in order to observe research ethics, they will be assured about the confidentiality of information and the possibility of leaving the study at any stage. Questionnaires of demographic characteristics, physiological criteria and Adaptation to the intensive care environment (ATICE), new sedation assessment instrument will be completed in patients in the control group. In this group, patients will receive only routine sedation care in the form of sedatives prescribed by a physician. After a week, the information of the control group will be collected using questionnaires and will be analyzed according to the goals of the study.</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:
The data obtained from the study will be published in the form of research project report and article without mentioning the names of the participants.

When:
The access period will start 6 months after the publication of the results.

To whom:
Researchers working in academic and scientific institutions

Conditions:
There will be access to data to compare the results of the study in similar trials.

Where to obtain:
phone:09199135395
email:atefe.salimi@yahoo.com

How to obtain:
In the articles resulting from the study, the e-mail of the responsible author and other authors will be included, and through this, researchers can communicate with the authors and submit their request, which will be answered in the shortest possible time.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Atefe Salimi Akin Abadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Modarres hospital,Saadatabad intersection, Yadegar Imam Highway, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1998734383</zip>
        <telephone>+98 21 2207 4087</telephone>
        <email>atefe-salimi@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Atefe Salimi Akin Abadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Modarres hospital, Saadatabad intersection ,  Yadegar Imam Highway, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1998734383</zip>
        <telephone>+98 21 2207 4087</telephone>
        <email>atefe-salimi@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with consciousness 15 according to Glasgow coma scale
Patients aged 18 to 70 years old
Patients admitted to the corona intensive care unit for at least 3 days
Patients undergoing oxygen therapy through non-invasive mechanical ventilation for at least 3 days</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with a history of non-invasive mechanical ventilation prior to hospitalization
Patients with visual and auditory problems
Patients with movement disorders and paralysis
Psychiatric patient  and taking sedatives before hospitalization</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>U07.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>COVID-19, virus identified</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: Before performing the intervention, after explaining the objectives of the study, informed consent will be obtained from the patients of the intervention group and in order to observe research ethics, they will be assured about the confidentiality of information and the possibility of leaving the study at any stage. The intervention will be performed on patients in this group. Prior to the intervention, demographic questionnaires, physiological criteria and Adaptation to the intensive care environment (ATICE), new sedation assessment instrument will be completed. In this group, in addition to routine care, the intervention will be an explanation of the goals of guided imagery and progressive muscle relaxation , an explanation of the positive effects and usefulness of this method, based on the article by Ghaffari et al. (2007), guided imagery and progressive muscle relaxation  as a non-pharmacological treatment will be held individually for 4 days a week for 30 minutes every other day. The researcher will be present at each patient's bedside and will teach guided imagery and progressive muscle relaxation techniques. In this way, in the evening shift, when the ward is quieter and environmental stimuli such as noise and commuting caused by visits are less, he is present in the intensive care unit and is present at each patient's bedside and tells the patient about guided imagery and progressive muscle relaxation. guided imagery and progressive muscle relaxation are often used together because visualization can enhance the relaxation process and enhance its effect. This method is one of the components of cognitive-behavioral therapy that is designed to reduce stress and anxiety through muscle relaxation. In the first session, regarding the goals and stages of the training program, theoretical foundations related to the guided imagery and progressive muscle relaxation technique, introducing muscles and muscle groups, training on how and steps to perform the relaxation technique along with guided imaging and the time of relaxation technique. Will be trained. During the second to fourth sessions to start the exercises, for physical relaxation, the patient is asked to be in the supine position, after a few deep breaths of the abdomen and diaphragm with the eyes closed and comfortable, in the best position in which he feels relaxed. In the first 20 minutes of the session, relaxation exercises will be performed, during which the mind will focus on the contraction of the muscles of different parts of the body and then their rest. Relaxation exercises for 8 muscle groups including arm muscles, upper arm muscles, shoulder and neck muscles, back and shoulder muscles, facial muscles, chest muscles involved in the process of breathing exercises, abdominal muscles, muscles The first step is to consciously relieve tension on the muscles, and in the final 10 minutes of the session, guided imagery with a focus on depicting a desirable scene and custom (forest, beach, religious places, hospital discharge and presence with family, reducing the need for oxygen therapy and comfortable breathing ...) will be done. During the imaging, the patient will visualize a scene in which he feels safe and free from tension and anxiety, and with the voice of the researcher, the imaging is done for the patient and the patient enters a pleasant atmosphere that is his favorite. In general, people are encouraged to take deep abdominal and diaphragmatic breaths and then combine muscle release with depictions of landscapes such as forests, the beach, or places of pilgrimage. Progressive muscle relaxation and visualization are often used together because visualization can enhance the relaxation process and increase its effectiveness. The patient will perform sedation technique under the supervision of the researcher and feedback will be taken from the patient after each session. Before the start of each session, the researcher will answer patients' possible questions about the relaxation technique and feedback on the positive experiences of the previous session. Patients' physiological criteria will also be recorded before and after each relaxation session. At the end of the session, patients are asked to write down the number of times they do relaxation exercises and guided imagery. Finally, after the end of the fourth session, the information of this group will be collected using questionnaires and will be analyzed according to the goals of the study.</i_keyword>
      <i_keyword>Control group:  informed consent will be obtained from the patients of the control group and in order to observe research ethics, they will be assured about the confidentiality of information and the possibility of leaving the study at any stage. Questionnaires of demographic characteristics, physiological criteria and Adaptation to the intensive care environment (ATICE), new sedation assessment instrument will be completed in patients in the control group. In this group, patients will receive only routine sedation care in the form of sedatives prescribed by a physician. After a week, the information of the control group will be collected using questionnaires and will be analyzed according to the goals of the study.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sedation. Timepoint: In the intervention group before of the intervention and after the intervention / in the control group at the beginning of the study and one week after the initial completion of the questionnaire. Method of measurement: Adaptation to the intensive care environment (ATICE), new sedation assessment instrument.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-02-21</approval_date>
        <contact_name>Shahid Beheshti University of Medical Sciences, School of Nursing and Midwifery</contact_name>
        <contact_address>Arabi Ave, Bldg No.2 SBUMS, 7th Floor, Velenjak, Tehran, Tehran Province Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
