<?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>IRCT20130603013568N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-04-24</date_registration>
      <primary_sponsor>Kermanshah University of Medical Sciences</primary_sponsor>
      <public_title>Effects of Color Therapy on patient’s anxiety under chemotherapy</public_title>
      <acronym></acronym>
      <scientific_title>The Effects of Color Therapy on patient’s anxiety under chemotherapy in oncology unit:A Randomized Clinical Trial study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-12-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>189</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69055</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: It will be simple randomization with random assignment to intervention and control groups and using a table of random numbers from top to bottom.
First, the patients in the study are placed in the waiting room and are registered by the researcher, then the researcher moves from top to bottom by using the table of random numbers and in order to allocation Concealmen the numbers are written on a card and the cards are placed in the letter envelopes in order. In order to preserve the random sequence, the pass number is done in the same order on the outer surface of the envelopes. Finally, the lid of the letter envelopes is glued and placed in a box. At the time of registration of the participants, the order of entry of qualified participants into the study, one of the envelopes will be opened in order and the assigned group will participate. Each sample will be assigned a number. The study subjects are divided into two groups of 95 people (total study 189 people) A and B, the even numbers of group A, which is the intervention group, and the odd numbers of group B, which is the control group, Blinding description: In this study, blinding is done in a one-way blind method, in such a way that after registering and assigning an envelope to them, in order to determine the intervention or control group, according to the number in the envelope, the subjects left the waiting room. He/She passed through the rooms and if the number inside the envelope seen by the researcher is an even number, the person in question will go to the intervention room, and if the number is odd, the sample will go to the control room.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Anxiety.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention group: First, they fill out the Beck questionnaire, then they are transferred to one of the two private rooms of the ward through a corridor that is not clear inside the rooms, these rooms are blue in color with blue light, blue bedspread, blue pillowcase and blue blanket. , the curtain around the bed is blue, the lacquer is blue, and the flowers are blue, and they stay in this room for 20 minutes, and then Beck's questionnaire is given to them and the level of anxiety is measured. Intervention 2: Control group:First, they fill out the Beck questionnaire, then they are transferred to one of the common rooms of the ward through a corridor that is not clear inside the rooms, which are white with the usual color range of the ward, and have moonlight, white bedding, The white pillowcase and blanket, the curtain around the bed is green, the lacquer is green, and they stay in this room for 20 minutes, and then Beck's questionnaire is given to them and the level of anxiety is measured.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is For keeping anonymous</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Rostam Jalali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing Department ,Faculty of Nursing and Midwifery, Dolat Abad Blvd</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6719851351</zip>
        <telephone>+98 83 3724 6613</telephone>
        <email>ks_jalali@yahoo.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Rostam Jalali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing Department, Faculty of Nursing and Midwifery, Dolat Abad Blvd</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6719851351</zip>
        <telephone>+98 83 3724 6613</telephone>
        <email>ks_jalali@yahoo.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Do at least one chemotherapy session
Hospitalization for more than 6 hours for chemotherapy
Willingness to participate in the study</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unwillingness to participate in the study
Failure to fully complete the questionnaire</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F43</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Reaction to severe stress, and adjustment disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention group: First, they fill out the Beck questionnaire, then they are transferred to one of the two private rooms of the ward through a corridor that is not clear inside the rooms, these rooms are blue in color with blue light, blue bedspread, blue pillowcase and blue blanket. , the curtain around the bed is blue, the lacquer is blue, and the flowers are blue, and they stay in this room for 20 minutes, and then Beck's questionnaire is given to them and the level of anxiety is measured.</i_keyword>
      <i_keyword>Control group:First, they fill out the Beck questionnaire, then they are transferred to one of the common rooms of the ward through a corridor that is not clear inside the rooms, which are white with the usual color range of the ward, and have moonlight, white bedding, The white pillowcase and blanket, the curtain around the bed is green, the lacquer is green, and they stay in this room for 20 minutes, and then Beck's questionnaire is given to them and the level of anxiety is measured.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety. Timepoint: Before and after intervention. Method of measurement: Beck's 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>Kermanshah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-02-28</approval_date>
        <contact_name>Ethics committee of Kermanshah University of Medical Sciences</contact_name>
        <contact_address>Shahid Beheshti Blvd Kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
