<?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>IRCT20151004024342N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-09-06</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Benson relaxation technique and the sound of nature on the pain anxiety and body image burn patients admitted to the intensive care unit.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the effect of Benson relaxation technique and the sound of nature on the pain anxiety and body image burn patients admitted to the intensive care unit.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58379</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In connection with the sampling method, first the samples with inclusion criteria will be selected by the available method, then using the method, the blocking of samples will be assigned to three groups. The process of simple random allocation will be done using software, random allocation. Group randomization is shown in Appendix 6. With random allocation software, 10 blocks of six will be produced.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Burn patients.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: In the group of nature sound for patients, the sound of nature includes (bird sound, calm rain sound, river flow, waterfall sound and walking in the forest) where all sounds are recorded in a row and through metronome software and After consulting with an expert musician, it is approved and used by the speaker for 30 minutes in the morning before changing the dressing and before taking painkillers for patients, and the volume of the speaker based on patients' requests and on average in the range Is set at 25 to 50 dB and patients are asked to close their eyes and relax while listening to the sounds of nature, including unpleasant thoughts (body image problems that cause symptoms such as Grief, sadness, distance from people, extreme sensitivity, impaired self-perception, and lack of self-confidence can be avoided. Intervention 2: Intervention Group II: In the Benson Relaxation Group recorded audio tape Instructions for performing the Benson Relaxation technique using a speaker For the patient in the morning (30 minutes before changing the dressing and before taking painkillers) is spread in the patient's room and taught by the researcher.</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 There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Vida Shafipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nasibeh School of Nursing and Midwifery, Vesal Shirazi Street, Amir Mazandarani Boulevard</address>
        <city>sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4816715793</zip>
        <telephone>+98 911 151 9667</telephone>
        <email>v.shafipour@mazuma.ac.ir</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Vida SHafipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nasibeh School of Nursing and Midwifery, Vesal Shirazi Street</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4816715793</zip>
        <telephone>+98 11 3336 7342</telephone>
        <email>v.shafipour@mazuma.ac.ir</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Be vigilant and able to cooperate and communicate clearly with the researcher
Age 18 years old or older
Hospitalized in a burn ward that is 24 hours after the burn injury
Grade 2 burn with an area of 30% or more or a grade 2 burn with an area of 15% in case of involvement (head, neck and face, genital area)
Grade 3 burns</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Exacerbation of physical condition (connection to ventilator and decreased level of consciousness)
Death or discharge from hospital during the study
Discoloration of the wound due to infection (based on positive wound culture)
Inability to participate in the intervention for seven days Consecutively
History of mental illness (patients who, according to their statements and / or relatives and history in the file, history of psychiatric disorder and / or taking psychotropic drugs)
Severe anxiety
Mental-cognitive disability
Drug addiction
Blindness and deafness
Lack of relaxation skills after training during the intervention 
Burns are due to self-immolation.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T20 - T25</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>burns and corrosions of:    first degree [erythema]    second degree [blisters] [epidermal loss]    third degree [deep necrosis of underlying tissue] [full-thickness skin loss]</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: In the group of nature sound for patients, the sound of nature includes (bird sound, calm rain sound, river flow, waterfall sound and walking in the forest) where all sounds are recorded in a row and through metronome software and After consulting with an expert musician, it is approved and used by the speaker for 30 minutes in the morning before changing the dressing and before taking painkillers for patients, and the volume of the speaker based on patients' requests and on average in the range Is set at 25 to 50 dB and patients are asked to close their eyes and relax while listening to the sounds of nature, including unpleasant thoughts (body image problems that cause symptoms such as Grief, sadness, distance from people, extreme sensitivity, impaired self-perception, and lack of self-confidence can be avoided.</i_keyword>
      <i_keyword>Intervention Group II: In the Benson Relaxation Group recorded audio tape Instructions for performing the Benson Relaxation technique using a speaker For the patient in the morning (30 minutes before changing the dressing and before taking painkillers) is spread in the patient's room and taught by the researcher.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain anxiety. Timepoint: Pain Anxiety Questionnaire (before the intervention and before changing the dressing (first time = T1), after the intervention and before changing the dressing and before taking painkillers (second time = T2) and after changing the dressing (Third time = T3)) is evaluated on the first, fourth and seventh days. Method of measurement: Burn Specific Pain Anxiety Scale (BSPAS).</prim_outcome>
      <prim_outcome>Body image. Timepoint: Body image of the body in patients with burns is performed the day before the intervention and 7 days after the intervention. Also, the assessment of the body image of the patients' bodies is continued and performed in week 3 and week 5. The intervention is performed in the first week with the presence of the researcher. After that, the intervention of the trainings given to the patients by the researcher, the intervention is performed by the patients themselves every day at a certain time of the day and regularly and the interventions are followed by the researcher. Method of measurement: Satisfaction With Appearance Scale (SWAP).</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>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-08-28</approval_date>
        <contact_name>Ethics Committee of Mazandaran University of Medical Sciences</contact_name>
        <contact_address>Building No. 2, Vice Chancellor for Research, Mazandaran University of Medical Sciences, Moallem Square Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
