<?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>IRCT20240123060777N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-07-19</date_registration>
      <primary_sponsor>Bojnourd University of Medical Sciences</primary_sponsor>
      <public_title>The effect of laughter yoga on the quality and life expectancy of elderly people living in nursing homes</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of laughter yoga training on the quality and life expectancy of elderly people living in nursing homes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-07-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/75155</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: People will be randomly divided into two control groups (20 people) and intervention group (20 people). In this way, closed envelopes will be used for random allocation. Participants choose one envelope from among the 40 envelopes in the box, 20 of which contain the "A" card and the other 20 envelopes contain the "B" card. If they take the "A" card, they will be in the intervention group, and if they take the "B" card, they will be in the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Life expectancy and quality of life of the elderly..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 20 elderly people will randomly receive 12 sessions for 100 minutes of laughter yoga training in North Khorasan nursing homes by a psychologist. The objectives and topics of the sessions will be as follows: First session: Getting to know the elderly;  2. Familiarizing the elderly with the benefits of laughter;  3. Introducing each participant and laughing at the one who introduces himself;  4. Handshake and warming, laughter and congratulations;  5. Greetings in Hindi (Namaste), and shake hands;  and 6. Meditation and relaxation with positive and motivational words.  The second session: laughing and congratulating;  2. Talking about the previous meeting;  3. Holding hands and warming up;  4. Deep breathing;  5. laughter of reasoning;  6. Forgiveness of laughter;  7. Appreciate laughter;  8. Show a movie;  9. Reading comic books; 10. meditation and relaxation.  The third session: 1. Laughing and congratulating;  2. Talking about previous meetings;  3. Holding hands and warming up;  4. Cell phone laughter;  5. Japanese greeting;  6. A moment of laughter;  7. Showing a movie;  8. Reading a comic book; 9. meditation and relaxation.  The fourth session: 1.  exercise and stretching;  2. Laughing and congratulating;  3. Talking about previous meetings;  4. Hand grip and heating;  5. Rhythmic sounds and movements;  6. Shy laugh;  7. Cell phone laughter;  8. Show a movie;  9. Reading a comic book; 10. Meditation and relaxation, the fifth session: 1.  laughing and congratulating;  2. Talking about previous meetings;  3. Holding hands and warming up;  4. Appreciate laughter;  5. Laughter of one meter;  6. Showing a movie;  7. Reading a comic book; 8. meditation and relaxation.  The sixth session: 1.  laughing and congratulating;  2. Talking about previous meetings;  3. Holding hands and warming up;  4. Deep breathing;  5. Lion's laugh;  6. Loud laughter;  7. Showing a movie;  8. Reading a comic book; 9. meditation and relaxation.  The seventh session: 1.  laughter and congratulations;  2. Talking about previous meetings;  3. Holding hands and warming up;  4. Laughter Seesaw;  5. Bicycle laughter;  6. Happy laughter;  7. Showing a movie;  8. Reading a comic book; 9. Meditation and relaxation.  Eighth session: 1. Laughter and congratulations;  2. Talking about previous meetings;  3. Holding hands and warming up;  4. Argument of laughter;  5. Laughter 6. Joyful laughter;  7. Showing a movie;  8. Reading a comic book; 9. meditation and relaxation.  The ninth session: 1.  laughter and congratulations;  2. Talking about previous meetings;  3. Holding hands and warming up;  4. Appreciate laughter;  5. Rhythmic sounds and movements;  6. Loud laughter;  7. Showing a movie;  8. Reading a comic book; 9. meditation and relaxation.  Tenth session: 1.  laughter and congratulations;  2. Talking about previous meetings;  3. Holding hands and warming up;  4. Deep breathing;  5. Laughter of gratitude;  6. Japanese greeting;  7. Showing a movie;  8. Reading a comic book; 9. Meditation and relaxation of the 11th session: 1.  laughter and congratulations;  2. Talking about previous meetings;  3. Holding hands and warming up;  4. Deep breathing;  5. Bicycle laughter;  6. Forgiveness of laughter;  7. Showing a movie;  8. Reading a comic book; 9. meditation and relaxation.  12th session: 1. Laughter and congratulations;  2. Talking about previous meetings;  3. Holding hands and warming up;  4. Deep breathing;  5. Loud laughter;  6. Happy laughter;  7. Showing a movie;  8. Reading a comic book; 9. Meditation. Intervention 2: Control group: Random selection of 20 elderly people, filling out the questionnaires, not receiving laughter yoga sessions, filling out the questionnaires again.</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:
The data will be accessible through publication in reputable journals, but the names of the participants will not be mentioned

When:
Access starts 8 months after results are published

To whom:
Public

Conditions:
If the researchers need to receive more information from the research, they can submit their request through the responsible author's email, and the requests will be made within the ethical framework. are realized

Where to obtain:
Corresponding author contact will be made available.
nurse.saedikia@yahoo.com  Email
09385746207 Contact phone
9461976199 Postal code
05836229535 Contact phone

How to obtain:
All sufficient information will be available in the printed version. If you need more information, you can contact the responsible author through communication channels.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Azam Saedikia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Next to Social Security Organization, Imam Khomeini Boulevard, Shirvan Town, North Khorasan.</address>
        <city>Shirvan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>74877-94149</zip>
        <telephone>+98 938 574 6207</telephone>
        <email>nurse.saedikia@yahoo.com</email>
        <affiliation>Bojnourd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Azam Saedikia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Next to Social Security Organization, Imam Khomeini Boulevard, Shirvan Town, North Khorasan.</address>
        <city>Shirvan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>74877-94149</zip>
        <telephone>+98 938 574 6207</telephone>
        <email>nurse.saedikia@yahoo.com</email>
        <affiliation>Bojnourd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Complete the informed consent form
Elderly residents of Bojnord city nursing homes
The birth certificate age of people is over 60 years old
Without severe and chronic physical and mental illness based on the medical record
Able to communicate with others
Have no hearing and speech disorders disrupting communication
Not having dementia or severe disability</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Participate in Laughter Yoga sessions beforehand
Severe memory loss
Do not live in a nursing home
Not a resident of Bojnoord city</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>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 20 elderly people will randomly receive 12 sessions for 100 minutes of laughter yoga training in North Khorasan nursing homes by a psychologist. The objectives and topics of the sessions will be as follows: First session: Getting to know the elderly;  2. Familiarizing the elderly with the benefits of laughter;  3. Introducing each participant and laughing at the one who introduces himself;  4. Handshake and warming, laughter and congratulations;  5. Greetings in Hindi (Namaste), and shake hands;  and 6. Meditation and relaxation with positive and motivational words.  The second session: laughing and congratulating;  2. Talking about the previous meeting;  3. Holding hands and warming up;  4. Deep breathing;  5. laughter of reasoning;  6. Forgiveness of laughter;  7. Appreciate laughter;  8. Show a movie;  9. Reading comic books; 10. meditation and relaxation.  The third session: 1. Laughing and congratulating;  2. Talking about previous meetings;  3. Holding hands and warming up;  4. Cell phone laughter;  5. Japanese greeting;  6. A moment of laughter;  7. Showing a movie;  8. Reading a comic book; 9. meditation and relaxation.  The fourth session: 1.  exercise and stretching;  2. Laughing and congratulating;  3. Talking about previous meetings;  4. Hand grip and heating;  5. Rhythmic sounds and movements;  6. Shy laugh;  7. Cell phone laughter;  8. Show a movie;  9. Reading a comic book; 10. Meditation and relaxation, the fifth session: 1.  laughing and congratulating;  2. Talking about previous meetings;  3. Holding hands and warming up;  4. Appreciate laughter;  5. Laughter of one meter;  6. Showing a movie;  7. Reading a comic book; 8. meditation and relaxation.  The sixth session: 1.  laughing and congratulating;  2. Talking about previous meetings;  3. Holding hands and warming up;  4. Deep breathing;  5. Lion's laugh;  6. Loud laughter;  7. Showing a movie;  8. Reading a comic book; 9. meditation and relaxation.  The seventh session: 1.  laughter and congratulations;  2. Talking about previous meetings;  3. Holding hands and warming up;  4. Laughter Seesaw;  5. Bicycle laughter;  6. Happy laughter;  7. Showing a movie;  8. Reading a comic book; 9. Meditation and relaxation.  Eighth session: 1. Laughter and congratulations;  2. Talking about previous meetings;  3. Holding hands and warming up;  4. Argument of laughter;  5. Laughter 6. Joyful laughter;  7. Showing a movie;  8. Reading a comic book; 9. meditation and relaxation.  The ninth session: 1.  laughter and congratulations;  2. Talking about previous meetings;  3. Holding hands and warming up;  4. Appreciate laughter;  5. Rhythmic sounds and movements;  6. Loud laughter;  7. Showing a movie;  8. Reading a comic book; 9. meditation and relaxation.  Tenth session: 1.  laughter and congratulations;  2. Talking about previous meetings;  3. Holding hands and warming up;  4. Deep breathing;  5. Laughter of gratitude;  6. Japanese greeting;  7. Showing a movie;  8. Reading a comic book; 9. Meditation and relaxation of the 11th session: 1.  laughter and congratulations;  2. Talking about previous meetings;  3. Holding hands and warming up;  4. Deep breathing;  5. Bicycle laughter;  6. Forgiveness of laughter;  7. Showing a movie;  8. Reading a comic book; 9. meditation and relaxation.  12th session: 1. Laughter and congratulations;  2. Talking about previous meetings;  3. Holding hands and warming up;  4. Deep breathing;  5. Loud laughter;  6. Happy laughter;  7. Showing a movie;  8. Reading a comic book; 9. Meditation</i_keyword>
      <i_keyword>Control group: Random selection of 20 elderly people, filling out the questionnaires, not receiving laughter yoga sessions, filling out the questionnaires again.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Coefficient score in Schneider's life expectancy questionnaire. Timepoint: before the intervention and 1 week after the intervention. Method of measurement: Using Schneider's life expectancy questionnaire.</prim_outcome>
      <prim_outcome>Coefficient score in Lipad elderly quality of life questionnaire. Timepoint: before the intervention and 1 week after the intervention. Method of measurement: Using Lipad elderly quality of life 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>Bojnourd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-11-29</approval_date>
        <contact_name>Ethics Committee of North Khorasan University of Medical Sciences</contact_name>
        <contact_address>South side of Imam Ali Hospital (AS), Shahriar St, Bojnoord. Bojnord North Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
