<?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>IRCT20221225056922N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-01-04</date_registration>
      <primary_sponsor>Birjand University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of virtual reality and the effect of rose scent on onexiety , quality sleep and happiness hemodialysis</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of virtual reality and the effect of rose scent on onexiety , quality sleep and happiness hemodialysis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67657</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: The study was done in 4 groups and comparing the groups with each other, Randomization description: The selected community was divided into four groups: aroma therapy (B), virtual reality (C), combined group (aroma therapy and virtual reality) (D) and control group (A). Dialysis was randomized and an intervention was randomly performed every day.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Anxiety, happiness, sleep quality.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group: Aromatherapy group, 3 drops of rare rose essential oil (rose water) with a concentration of 25%, which is readily available in the market, was dripped on absorbent cloth with a dropper and placed inside the patient's mask (due to the conditions of Corona). and the patient was asked to breathe normally for 15 minutes due to the possibility of spreading the aroma on the mask and reducing the lasting effects of the aroma, after the duration of aromatherapy the patients' masks were changed. The intervention was done once a week for four weeks. Intervention 2: Intervention group: Intervention group: virtual reality group, in the virtual reality group, using 3D glasses, calming images of the patients' favorite scenes were played for 15 minutes. This was done once a week for four weeks. Intervention 3: Intervention group: Intervention method: the combined group (aromatherapy and virtual reality) of the scent of rare rose essence (rose water) with a concentration of 25%, which is ready in the market, was dripped 3 drops with a dropper on an absorbable cloth and placed inside the patient's mask (to the reason for the condition of Corona) was placed and the patient was asked to breathe normally for 15 minutes and at the same time, using 3D glasses, soothing images of the patients' favorite scenes were played for 15 minutes. The intervention was once a week for four weeks. Done. Intervention 4: Control group: Control group: no intervention was performed during the study period, but after collecting the questionnaires at the end of the intervention, for ethical reasons, according to the wishes of the patients in this group, one of the interventions was performed in one session.</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fahime Heyrati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>The third alley on the right,Imam Khomeini 39</address>
        <city>Torbat Jam</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9591783753</zip>
        <telephone>+98 51 5254 7480</telephone>
        <email>heyratifahime1364@gmail.com</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fahime Heyrati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>The third alley on the right,Imam Khomeini 39</address>
        <city>Torbat Jam</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9591783753</zip>
        <telephone>+98 51 5254 7480</telephone>
        <email>heyratifahime1364@gmail.com</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>- Satisfaction and willingness to participate in research- Having at least 3 months of hemodialysis experience- Not having hearing, vision and smell problems- No mental illness or accident in the past 6 years- Not having debilitating diseases (dementia and Parkinson's)- Not sensitive to smell- Not using sleeping and anti-anxiety drugs or other therapeutic measures such as using herbal essences during the intervention period</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>- Death or absence of a session in intervention sessions- Sensitization to essential oil- Refusal to continue participating in the research</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>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: Aromatherapy group, 3 drops of rare rose essential oil (rose water) with a concentration of 25%, which is readily available in the market, was dripped on absorbent cloth with a dropper and placed inside the patient's mask (due to the conditions of Corona). and the patient was asked to breathe normally for 15 minutes due to the possibility of spreading the aroma on the mask and reducing the lasting effects of the aroma, after the duration of aromatherapy the patients' masks were changed. The intervention was done once a week for four weeks</i_keyword>
      <i_keyword>Intervention group: Intervention group: virtual reality group, in the virtual reality group, using 3D glasses, calming images of the patients' favorite scenes were played for 15 minutes. This was done once a week for four weeks.</i_keyword>
      <i_keyword>Intervention group: Intervention method: the combined group (aromatherapy and virtual reality) of the scent of rare rose essence (rose water) with a concentration of 25%, which is ready in the market, was dripped 3 drops with a dropper on an absorbable cloth and placed inside the patient's mask (to the reason for the condition of Corona) was placed and the patient was asked to breathe normally for 15 minutes and at the same time, using 3D glasses, soothing images of the patients' favorite scenes were played for 15 minutes. The intervention was once a week for four weeks. Done.</i_keyword>
      <i_keyword>Control group: Control group: no intervention was performed during the study period, but after collecting the questionnaires at the end of the intervention, for ethical reasons, according to the wishes of the patients in this group, one of the interventions was performed in one session.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety score in the Spielberger questionnaire. Timepoint: Before the start of the intervention and after the end of the intervention. Method of measurement: Spielberger Anxiety Questionnaire.</prim_outcome>
      <prim_outcome>Sleep quality score in the Pittsburgh Questionnaire. Timepoint: Before the start of the intervention and after the end of the intervention. Method of measurement: Pittsburgh Questionnaire.</prim_outcome>
      <prim_outcome>Happiness score in the Oxford Happiness Questionnaire. Timepoint: Before the start of the intervention and after the end of the intervention. Method of measurement: Oxford Happiness 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>Birjand University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-01-29</approval_date>
        <contact_name>Ethics Committee of Birjand University of Medical Sciences</contact_name>
        <contact_address>third alley on the right , 39 Imam Khomeini Street Torbat jam Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
