<?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>IRCT20180429039463N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-08-21</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of  laugher yoga on emesis  and  mental wellbeing  in  patients under chemotherapy with non-metastatic cancer</public_title>
      <acronym></acronym>
      <scientific_title>The effect of  laugher yoga on emesis  and  mental wellbeing  in  patients under chemotherapy with non-metastatic cancer</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/31424</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Random Type: Simple
In this method, computer randomization methods are used, and the division of people into two groups is done randomly by the sequence generated by SPSS software. The unit is the individual accident. Allocation Concealment Hiding is done by the statistic consultant.</study_design>
      <phase>N/A</phase>
      <hc_freetext>cancer.</hc_freetext>
      <i_freetext>Intervention 1: "In the intervention group": people will laugh yoga for 20-30 minutes before the first to fourth chemotherapy sessions. Laugh yogic exercises include four main clapping steps, deep breathing, child play and laughter exercises. This program will be performed by the researcher (after receiving the necessary training) and under the supervision of a yoga laughter coach at the hall next to the chemo therapy section. The yoga program is laughing at talking about some cheerful issues such as national and religious ceremonies, having a positive sense of everyday life, and so on. Then touching with tracks 1, 2, and 3 begins to touch open hands so that the fingers and palms of each other are in contact. We continue to move up and down and form a pendulum with movement in other parts of the body. Then the voice is simple and simple as Ho Ho. In addition, coordinated movements have been added for fertility enhancer. Broken words and words, such as words used by children in the game, are said to help in reducing individual impediments and talent. Later, the exercises begin to start laughing, which helps the person to experience mental and physical relaxation. Laughter is looking for laughter. Later, yoga exercises begin, so that each exercise lasts about 30 to 45 seconds with the touch of ho ho horns and deep deep deeps, including laughing yoga practice techniques (laughter, laughter with closed mouths, gradual laughter) Laughter laugh, laughter, laughter, laughter, telephone conversation, laughter) and laughter techniques (laughter and laughter laugh, laughter, laughter, laughter, laughter ...). This program takes about 5 minutes. At the end of the contest, the words are said loudly: "I am the happiest man on earth". They repeat themselves and look at each other and laugh. It takes about 5 minutes. After each yoga session, chemotherapy is performed according to the protocol in the center. Intervention 2: Control group: Except for the usual self-care education to control the nausea by the researcher (about 5 minutes), no further action will be taken.</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:
Presenting findings from research in seminars, conferences and publication of articles extracted from research in domestic and abroad journals for the use of non-metastatic cancer patients as well as researchers who intend to conduct research related to the subject matter.

When:
Start the access period 6 months after printing the results

To whom:
Delivering research results to other researchers for further research.

Conditions:
The results obtained in this study can be found in the oncology (cancer) sections of all hospitals and even in other sections, especially in chronic patients who require special medications due to their long-term complications and special care. Have to be used.

Where to obtain:
Referring to Mashhad Nursing and Midwifery Faculty

How to obtain:
After sending the email to the person responsible for the response process begins.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Namazi Nia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bahonar Blvd</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948988</zip>
        <telephone>+98 51 5222 5280</telephone>
        <email>namazinm951@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Namazi Nia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bahonar Blvd</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948988</zip>
        <telephone>+98 51 5222 5280</telephone>
        <email>namazinm951@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>To chemotherapy, they have visited Imam Reza's center of Mashhad.
Age between 18 and 60 years old.
Be alert.
Have non-metastatic cancer (based on diagnostic tests, signs and clinical examinations and an approved oncology doctor).
Complete consent to participate in the research.
Auditory problems (full hearing despite the use of auxiliary equipment) and visual (the ability to read a newspaper at a distance of 30 centimeters with glasses).
The phone number should be available to the researcher for follow up.
A chemotherapy regimen with moderate or severe nausea.
The number of chemotherapy sessions between two to four sessions per week is prescribed to him.
There are no symptoms of osteomyitis (such as redness, burning and mouth ulcers, the presence of false membranes, and sputum in the mouth).
Do not have upper gastrointestinal cancer.
Do not use radiotherapy at the same time.
Mentally and physically, you can do yoga exercises.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Do not want to continue to participate in research.
At the time of the research, there was a major stress (close relatives' death, financial failure, etc.).
Worried and needs special care.
The chemotherapy program is postponed by thrombocytopenia or any other factor.
Diagnosis of metastasis is based on diagnostic tests by an oncology specialist.
Symptoms of osteomyitis (such as redness, burning and mouth ulcers, false membranes, and sputum in the mouth).
For whatever reason, you will not be able to attend laugh yoga sessions.
Changes to the chemotherapy regimen.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C80</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm without specification of site</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>"In the intervention group": people will laugh yoga for 20-30 minutes before the first to fourth chemotherapy sessions. Laugh yogic exercises include four main clapping steps, deep breathing, child play and laughter exercises. This program will be performed by the researcher (after receiving the necessary training) and under the supervision of a yoga laughter coach at the hall next to the chemo therapy section. The yoga program is laughing at talking about some cheerful issues such as national and religious ceremonies, having a positive sense of everyday life, and so on. Then touching with tracks 1, 2, and 3 begins to touch open hands so that the fingers and palms of each other are in contact. We continue to move up and down and form a pendulum with movement in other parts of the body. Then the voice is simple and simple as Ho Ho. In addition, coordinated movements have been added for fertility enhancer. Broken words and words, such as words used by children in the game, are said to help in reducing individual impediments and talent. Later, the exercises begin to start laughing, which helps the person to experience mental and physical relaxation. Laughter is looking for laughter. Later, yoga exercises begin, so that each exercise lasts about 30 to 45 seconds with the touch of ho ho horns and deep deep deeps, including laughing yoga practice techniques (laughter, laughter with closed mouths, gradual laughter) Laughter laugh, laughter, laughter, laughter, telephone conversation, laughter) and laughter techniques (laughter and laughter laugh, laughter, laughter, laughter, laughter ...). This program takes about 5 minutes. At the end of the contest, the words are said loudly: "I am the happiest man on earth". They repeat themselves and look at each other and laugh. It takes about 5 minutes. After each yoga session, chemotherapy is performed according to the protocol in the center</i_keyword>
      <i_keyword>Control group: Except for the usual self-care education to control the nausea by the researcher (about 5 minutes), no further action will be taken.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Frequency of nausea. Timepoint: Nausea before the onset of the intervention and at each chemotherapy session for up to four sessions. Method of measurement: MORROW ASSESSMENT OF NAUSEA AND EMESIS.</prim_outcome>
      <prim_outcome>Severe of nausea. Timepoint: Severe of Nausea before the onset of the intervention and at each chemotherapy session for up to four sessions. Method of measurement: MORROW ASSESSMENT OF NAUSEA AND EMESIS.</prim_outcome>
      <prim_outcome>Duration of nausea. Timepoint: Duration Nausea before the onset of the intervention and at each chemotherapy session for up to four sessions. Method of measurement: MORROW ASSESSMENT OF NAUSEA AND EMESIS.</prim_outcome>
      <prim_outcome>Frequency of vomiting. Timepoint: vomiting before the onset of the intervention and at each chemotherapy session for up to four sessions. Method of measurement: MORROW ASSESSMENT OF NAUSEA AND EMESIS.</prim_outcome>
      <prim_outcome>Duration of vomiting. Timepoint: Duration of  vomiting before the onset of the intervention and at each chemotherapy session for up to four sessions. Method of measurement: MORROW ASSESSMENT OF NAUSEA AND EMESIS.</prim_outcome>
      <prim_outcome>Severe of nausea. Timepoint: severe of  vomiting before the onset of the intervention and at each chemotherapy session for up to four sessions. Method of measurement: MORROW ASSESSMENT OF NAUSEA AND EMESIS.</prim_outcome>
      <prim_outcome>Well-being score. Timepoint: En well-being is measured once before the start of the first chemotherapy session and once after the fourth session of chemotherapy. Method of measurement: En To measure the score of well-being, we will use the Warwick-Edinburgh Subjective Well-Being Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Sleep quality. Timepoint: sleep quality is measured once before the start of the first chemotherapy session and once after the fourth session of chemotherapy. Method of measurement: Petersburg Sleep Quality Tool.</sec_outcome>
      <sec_outcome>Depression. Timepoint: Depression is measured once before the start of the first chemotherapy session and once after the fourth session of chemotherapy. Method of measurement: Beck Depression Tools.</sec_outcome>
      <sec_outcome>Quality of Life. Timepoint: Quality of Life is measured once before the start of the first chemotherapy session and once after the fourth session of chemotherap. Method of measurement: European Organization for Research and Treatment of Cancer tools.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-07-31</approval_date>
        <contact_name>Ethics committee of school of nursing &amp; midwifery-mashhad university of medical sciences</contact_name>
        <contact_address>Mashhad, Ibn Sina St.-doctora four war mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
