<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03814265</url>
  </required_header>
  <id_info>
    <org_study_id>LYMSSC26102018</org_study_id>
    <nct_id>NCT03814265</nct_id>
  </id_info>
  <brief_title>Effect of Laughter Yoga on Mental Symptoms Frequency and Level of Saliva Cortisol</brief_title>
  <official_title>Effect of Laughter Yoga on Mental Symptoms Frequency and Level of Saliva Cortisol</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ankara University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ankara University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to evaluate the effect of laughter yoga on mental symptom frequency&#xD;
      and salivary cortisol level among the 1st Year Nursing Students.&#xD;
&#xD;
      This is a randomized controlled study using pre-post-test design with control group. The&#xD;
      population of our research; Ankara University Faculty of Health Sciences Nursing Department&#xD;
      consisting of 202 students studying at the First Year.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to evaluate the effect of laughter yoga on mental symptom frequency&#xD;
      and salivary cortisol level among the 1st Year Nursing Students.&#xD;
&#xD;
      This is a randomized controlled study using pre-post-test design with control group. The&#xD;
      population of our research; Ankara University Faculty of Health Sciences Nursing Department&#xD;
      consisting of 202 students studying at the First Year. A descriptive question form will apply&#xD;
      to the entire population of the research.191 students fulfilling the criteria of this study&#xD;
      will be included. Eleven students who have not fullfilled this criteria the inclusion&#xD;
      criteria will be excluded from the study. Power analysis has been performed and the required&#xD;
      sample volume for each group has been calculated as 34 with 0,90 power and 0.05 margin of&#xD;
      error. Sample of the study consistsof 75 students considering the possibility of students&#xD;
      leaving the research. This 75 students will be divided into two groups as intervention group&#xD;
      (n=38) and control group (n=37). Intervention and control group have been randomly selected&#xD;
      among Ankara University Faculty of Health Sciences Nursing Department.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 14, 2017</start_date>
  <completion_date type="Actual">December 20, 2017</completion_date>
  <primary_completion_date type="Actual">December 5, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Measurement of mental symptoms</measure>
    <time_frame>Four weeks</time_frame>
    <description>Data Collection Form is Brief Symptom Inventory(BSI). There are 5 sub-dimensions and 53 items in total.BSI has 5 sub-dimensions: Anxiety, Hostility, Somatization, Depression, Anxiety. The total score for each subscale is divided by the number of items in that sub-scale. The height of the total scores taken from the scale indicates the frequency of the individual's symptoms. The person answering the scale marks one of the following for each question: (0) None; (1) Very little; (2) &quot;Moderate; (3) quite a lot; (4) Too much Application process consist of three phases such as; pre-test, intervention and post-test. During pre-test phase. Whether there is a significant decrease in posttest scores compared to pre-test mean scores.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measurement of saliva cortisol</measure>
    <time_frame>Each session for four weeks</time_frame>
    <description>Saliva samples for the study of salivary cortisol level. Saliva samples have been taken from intervention and control group students for measurement of salivary cortisol level at 07.55 am before each session. During the intervention phase; laughter yoga has been applied to the intervention group after the pre-test. There hasn't been any intervention for the control group during the research.Saliva samples have been taken from the students who have participated in the study at 08.40 am for each cortisol level measurement after each session. According to the Preliminary Test, it will be evaluated whether there is a significant decrease in the final test scores.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Nursing Caries</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Laughter yoga group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Laughter yoga</intervention_name>
    <description>440/5000 Laughter yoga; It is an exercise program that combines breathing techniques with unconditional laughter. During the sessions, laughter is simulated by hand clapping and warm-up exercises and by eye contact with other members in the group and by playing childish games with group members. Most of the time this simulation turns into genuine and contagious laughter. Laughter yoga is based on the argument that the brain cannot distinguish between real and unreal laugh.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ankara University Faculty of Health Sciences Department of Nursing to be a 1st year&#xD;
             student.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diabetes mellitus&#xD;
&#xD;
          -  Hypertension&#xD;
&#xD;
          -  Hypothyroidism&#xD;
&#xD;
          -  Hyperaldosteronism&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Malignancy&#xD;
&#xD;
          -  Congestive heart failure&#xD;
&#xD;
          -  Psychotic disorder&#xD;
&#xD;
          -  Chronic hepatic failure&#xD;
&#xD;
          -  Nephrotic syndrome&#xD;
&#xD;
          -  Chronic renal failure diagnosis&#xD;
&#xD;
          -  Using medical drug&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ayfer Tezel, Prof. Dr.</last_name>
    <role>Study Director</role>
    <affiliation>Ankara Uviversity</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ankara University</name>
      <address>
        <city>Ankara</city>
        <state>Altindag</state>
        <zip>06340</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>November 22, 2018</study_first_submitted>
  <study_first_submitted_qc>January 21, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>January 21, 2019</last_update_submitted>
  <last_update_submitted_qc>January 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ankara University</investigator_affiliation>
    <investigator_full_name>Fatma Ozlem Ozturk</investigator_full_name>
    <investigator_title>Lecturer Fatma Ozlem Ozturk</investigator_title>
  </responsible_party>
  <keyword>Cortisol</keyword>
  <keyword>Laughter Yoga</keyword>
  <keyword>Mental Symptom</keyword>
  <keyword>Nursing</keyword>
  <keyword>Student</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 14, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/65/NCT03814265/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 14, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/65/NCT03814265/SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 14, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/65/NCT03814265/ICF_002.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03814265
org study id: LYMSSC26102018
nct id: NCT03814265
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to evaluate the effect of laughter yoga on mental symptom frequency
      and salivary cortisol level among the 1st Year Nursing Students.

      This is a randomized controlled study using pre-post-test design with control group. The
      population of our research; Ankara University Faculty of Health Sciences Nursing Department
      consisting of 202 students studying at the First Year.
The aim of this study is to evaluate the effect of laughter yoga on mental symptom frequency
      and salivary cortisol level among the 1st Year Nursing Students.

      This is a randomized controlled study using pre-post-test design with control group. The
      population of our research; Ankara University Faculty of Health Sciences Nursing Department
      consisting of 202 students studying at the First Year. A descriptive question form will apply
      to the entire population of the research.191 students fulfilling the criteria of this study
      will be included. Eleven students who have not fullfilled this criteria the inclusion
      criteria will be excluded from the study. Power analysis has been performed and the required
      sample volume for each group has been calculated as 34 with 0,90 power and 0.05 margin of
      error. Sample of the study consistsof 75 students considering the possibility of students
      leaving the research. This 75 students will be divided into two groups as intervention group
      (n=38) and control group (n=37). Intervention and control group have been randomly selected
      among Ankara University Faculty of Health Sciences Nursing Department.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Measurement of mental symptoms
time frame: Four weeks
description: Data Collection Form is Brief Symptom Inventory(BSI). There are 5 sub-dimensions and 53 items in total.BSI has 5 sub-dimensions: Anxiety, Hostility, Somatization, Depression, Anxiety. The total score for each subscale is divided by the number of items in that sub-scale. The height of the total scores taken from the scale indicates the frequency of the individual's symptoms. The person answering the scale marks one of the following for each question: (0) None; (1) Very little; (2) "Moderate; (3) quite a lot; (4) Too much Application process consist of three phases such as; pre-test, intervention and post-test. During pre-test phase. Whether there is a significant decrease in posttest scores compared to pre-test mean scores.
measure: Measurement of saliva cortisol
time frame: Each session for four weeks
description: Saliva samples for the study of salivary cortisol level. Saliva samples have been taken from intervention and control group students for measurement of salivary cortisol level at 07.55 am before each session. During the intervention phase; laughter yoga has been applied to the intervention group after the pre-test. There hasn't been any intervention for the control group during the research.Saliva samples have been taken from the students who have participated in the study at 08.40 am for each cortisol level measurement after each session. According to the Preliminary Test, it will be evaluated whether there is a significant decrease in the final test scores.
arm group label: Intervention
arm group type: Experimental
description: Laughter yoga group
arm group label: Control
arm group type: No Intervention
description: No intervention
intervention type: Behavioral
intervention name: Laughter yoga
description: 440/5000 Laughter yoga; It is an exercise program that combines breathing techniques with unconditional laughter. During the sessions, laughter is simulated by hand clapping and warm-up exercises and by eye contact with other members in the group and by playing childish games with group members. Most of the time this simulation turns into genuine and contagious laughter. Laughter yoga is based on the argument that the brain cannot distinguish between real and unreal laugh.
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 25 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ayfer Tezel, Prof. Dr.
role: Study Director
affiliation: Ankara Uviversity
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Ankara University
investigator full name: Fatma Ozlem Ozturk
investigator title: Lecturer Fatma Ozlem Ozturk
sharing ipd: No
provided document: 
provided document: 
provided document: 