<?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>IRCT2016041027317N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-10-08</date_registration>
      <primary_sponsor>Vice chancellor for research; Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of humor therapy on chronic pain</public_title>
      <acronym></acronym>
      <scientific_title>Effect of humor therapy on chronic pain and its  related  disability of Mashhad city nursing homes residents</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-05-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/22406</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Chronic pain , Pain disability.</hc_freetext>
      <i_freetext>Intervention 1: In the intervention group:  Humor therapy for 6 continuous weeks, each week and each session 60 minutes a day was done. Therapeutic humor program includes video clips with fun themes (humorous videos), games with themes joke (humor games), humor and funny stories (Comic stories) and music with themed joke (humorous music) and  tell a jokes (jokes);That  Performed by professional colleagues and researcher. In all of the Humor therapy protocols,  have been used of experts opinion in this field related to this profession and is adjusted according to the culture elderly. Intervention 2: In the control group:  no plans or specific interventions  was done and only the elderly in control group, will be monitored during 6 weeks.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shohre Behrouz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mashhad Nursing School, Doktora street</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 51 3726 4608</telephone>
        <email>behrouzsh2@mums.ac.ir ; shohrebehrooz@yahoo.com</email>
        <affiliation>Mashhad Nursing School</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hadi Kooshyar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mashhad Nursing School, Doktora Street</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 518591511</telephone>
        <email>kooshyarh@mums.ac.ir</email>
        <affiliation>Assistant Professor; Department of Nursing; Faculty of Nursing and Midwifery; Mashhad  University of</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Have a desire to participate in the study; Over 60 years old and have less than 85; Have at least able to read and write; Have lived in a nursing home for at least three months; Having chronic non-cancer pain for at least 3 months; No history of taking antidepressants or exhilarating; The lack of visual impairment to the extent that it is able at a distance of 6 meters, see fingers; No hearing impaired to the extent that it is able at a distance of 1 meter, hear whispers; No problem in Language to the extent that the Executive be able to answer questions; Failure to develop scenarios that you may have a problem laughing (hernia, advanced hemorrhoids, surgery over the past three months, drooping uterus, glaucoma, epilepsy; Lack of drug addiction and drug use; scores 15-item Geriatric depression scale is less than 8;  lack of cognitive impairment, the Montreal cognitive test (MOCA) and earn a higher score of 26.&#13;
Exclusion criteria: Refusal to continue participating in the study and collaboration with researcher; Absence of more than two sessions, Subjects die; Leave the nursing home forever, Access physical or mental disorders in the elderly from participating in the meetings during the study; Having any acute pain, such as toothache, cramps caused by colds, hit a limb.</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>85 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z73.6, R52</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Limitation of activities due to disability, Other chronic pain</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the intervention group:  Humor therapy for 6 continuous weeks, each week and each session 60 minutes a day was done. Therapeutic humor program includes video clips with fun themes (humorous videos), games with themes joke (humor games), humor and funny stories (Comic stories) and music with themed joke (humorous music) and  tell a jokes (jokes);That  Performed by professional colleagues and researcher. In all of the Humor therapy protocols,  have been used of experts opinion in this field related to this profession and is adjusted according to the culture elderly.</i_keyword>
      <i_keyword>In the control group:  no plans or specific interventions  was done and only the elderly in control group, will be monitored during 6 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of Pain. Timepoint: Immediately before the first session, 24 h after the third session, 24 h after the sixth session (last session). Method of measurement: The short-form McGill Pain Questionnaire.</prim_outcome>
      <prim_outcome>Disability related to pain. Timepoint: Immediately before the first session, 24 h after the third session, 24 h after the sixth session (last session. Method of measurement: Modified German Version of the Brief Pain Inventory.</prim_outcome>
      <prim_outcome>Pain  Intensity. Timepoint: Immediately before and after each session. Method of measurement: Modified German Version of the Brief Pain Inventory.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Social Support. Timepoint: Immediatly Before the first sessain. Method of measurement: Duke Social Support.</sec_outcome>
      <sec_outcome>Sense of Humor. Timepoint: Immediatly before the first session. Method of measurement: Sense of Humor Questionnaire.</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>Vice chancellor for research; Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-05-07</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences, School of Nursing and Midwifery</contact_name>
        <contact_address>School of Nursing and Midwifery, St. IbneSina, Doktora intersection, University Avenue, Mashhad Mashhad  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
