<?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>IRCT20191129045546N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-12-12</date_registration>
      <primary_sponsor>Sabzevar University of Medical Sciences</primary_sponsor>
      <public_title>''The effect of blue light and green light with normal light on vital signs and anxiety level of patients''</public_title>
      <acronym>ندارد</acronym>
      <scientific_title>A comparison of the effect of  blue light  and green light with normal light on the vital signs and level anxiety of patients admitted to CCU</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>75</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/43833</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: First, simple sampling is done based on inclusion and exclusion criteria, and then simple random allocation will be assigned to each of the three groups in two intervention groups and one control group respectively. In other words, due to the limitations of the number of part 2, the first, second or control intervention will be randomly selected for implementation. And randomization does not occur in the samples.</study_design>
      <phase>N/A</phase>
      <hc_freetext>cardiovascular patients.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Spilberger anxiety questionnaire is used for patients included in the study. There are 10 numbers on the white LED light bulb. Patients are monitored with the Bliss Mark Monitor and are monitored and charted on a daily basis for ccu blood pressure, heart rate, spo2 and respiratory rate every half hour. The Buliss Mark Oral Thermostat will be used to control the temperature. At the end of the third day of admission to the ccu, the questionnaire is completed again by the patient. Intervention 2: Intervention group 1: In this group, Spiel Berger anxiety questionnaire will be filled out for patients then blue LED light will be used and all 60 Hz blue light bulbs with 55 mA current will be replaced. Patients will be monitored. Blue light will be available for patients from 7am to 12pm, and vital signs will be checked and monitored at half-hour intervals. Vital signs are checked during the time the light is not placed on the patient and at the end of the hospital stay the anxiety questionnaire is filled out. Intervention 3: Intervention group 2: In this group, Spiel Berger anxiety questionnaire will be filled for patients, then green light LED will be used and all light bulbs with 60 Hz voltage and 55 mA current will be replaced. Patients will be monitored. Green light will be available for patients from 7am to 12pm, and vital signs will be checked and monitored at half-hour intervals. Vital signs are checked during the time the light is not placed on the patient and at the end of the hospital stay the anxiety questionnaire is filled out.</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:
This study will be a clinical trial on 75 patients admitted to ccu ward of Imam Khomeini hospital in Esfarayen. These patients were recruited through random sampling and were included in the study excluding patients between the ages of 70-70 years who needed to be admitted to cardiac care units. Patients are randomly divided into three groups due to space constraints at three different times. For this purpose, the Spielberger Anxiety Inventory is administered to all patients included in the study. For the control group, a 60-Hz white light bulb with a current of 55 mA will be provided with a total of 10 units. Patients are monitored with the Bliss Mark Monitor and are monitored and charted daily on ccu blood pressure, heart rate, spo2 and respiratory rate every half hour. The Buliss Mark Oral Thermostat will be used to control the temperature. At the end of the third day of admission to the ccu, the questionnaire is completed again by the patient. The second group will use the blue LED light bulb and all of the 60 Hz blue light bulbs will be replaced with a 55 mA current. Patients will be monitored. Blue light will be available for patients from 7am to 12pm. The vital signs are checked and controlled every half hour according to the control group. The evening light is also set from 17:00 to 22:00. During the time that the light is not placed on the patient (to avoid fatigue, the rest of the time is considered), vital signs are checked and an anxiety questionnaire is filled at the end of the hospital stay. The third group uses a 60 Hz green LED lamp with a current of 55 mA, and all of the second group uses the third group.

When:
From the beginning of the intervention

To whom:
Researchers working in academic and scientific institutions

Conditions:
Keeping patients' personal information confidential

Where to obtain:
Sabzevar University of Medical Sciences

How to obtain:
Through email correspondence and automation

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>ّFarzaneh Hosseinpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 12   - Isar Street -Sepah Street -Esfarayn</address>
        <city>Sabzevar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9661968817</zip>
        <telephone>+98 58 3722 5426</telephone>
        <email>hosseinpourF97@medsab.ac.ir</email>
        <affiliation>Sabzevar University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>ّFarzaneh Hosseinpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 12   - Isar Street -Sepah Street -Esfarayn</address>
        <city>Sabzevar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9661968817</zip>
        <telephone>+98 58 3722 5426</telephone>
        <email>hosseinpourF97@medsab.ac.ir</email>
        <affiliation>Sabzevar University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1- Age between 30 and 70 years
2- Full patient consent to participate in the research as planned
3. No cognitive and cognitive impairment (coma, hearing loss, blindness, lack of awareness of time, place and person)
4- Being admitted to ccu
5. Ability to recognize colors</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>1- Having a history of mental illness
2- Diseases like severe asthma
3. Having an eye problem such as color blindness
4- Fever above 39 degrees
5. Severe hypoxia and spo2 below 85%</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>قلب</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>قلب</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: Spilberger anxiety questionnaire is used for patients included in the study. There are 10 numbers on the white LED light bulb. Patients are monitored with the Bliss Mark Monitor and are monitored and charted on a daily basis for ccu blood pressure, heart rate, spo2 and respiratory rate every half hour. The Buliss Mark Oral Thermostat will be used to control the temperature. At the end of the third day of admission to the ccu, the questionnaire is completed again by the patient</i_keyword>
      <i_keyword>Intervention group 1: In this group, Spiel Berger anxiety questionnaire will be filled out for patients then blue LED light will be used and all 60 Hz blue light bulbs with 55 mA current will be replaced. Patients will be monitored. Blue light will be available for patients from 7am to 12pm, and vital signs will be checked and monitored at half-hour intervals. Vital signs are checked during the time the light is not placed on the patient and at the end of the hospital stay the anxiety questionnaire is filled out.</i_keyword>
      <i_keyword>Intervention group 2: In this group, Spiel Berger anxiety questionnaire will be filled for patients, then green light LED will be used and all light bulbs with 60 Hz voltage and 55 mA current will be replaced. Patients will be monitored. Green light will be available for patients from 7am to 12pm, and vital signs will be checked and monitored at half-hour intervals. Vital signs are checked during the time the light is not placed on the patient and at the end of the hospital stay the anxiety questionnaire is filled out.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety of hospitalized patients. Timepoint: Measuring the level of anxiety before the intervention and re-measuring it after the intervention. Method of measurement: Spiegel Burger Anxiety Inventory.</prim_outcome>
      <prim_outcome>Vital signs. Timepoint: From the beginning of the intervention, the patient's vital signs are monitored and charted every half hour and continued until the end of the third day of hospitalization. Method of measurement: Vital signs (heart rate, respiratory rate, blood pressure, arterial saturation rate) are monitored by a monitor and monitored by a thermometer with a thermometer.</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>Sabzevar University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-11-23</approval_date>
        <contact_name>Ethics Committee of Sabzevar University of Medical Sciences</contact_name>
        <contact_address>No. 12, Isar Street, Sepah Street, Esfarayne Sabzevar Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
