xml: <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/NCT06008236</url>
    </required_header>
    <id_info>
      <org_study_id>SBU-NK-01</org_study_id>
      <nct_id>NCT06008236</nct_id>
    </id_info>
    <brief_title>The Effect of Progressive Relaxation and Breathing Exercises Accompanied by Music on the Stress Levels of Nursing Students and Their Bio-psycho-social Responses</brief_title>
    <official_title>The Effect of Progressive Muscle Relaxation and Deep Breathing Exercises Accompanied by Music on the Stress Levels of Nursing Students and Their Bio-psycho-social Responses to Stress</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Saglik Bilimleri Universitesi</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Saglik Bilimleri Universitesi</source>
    <oversight_info>
      <has_dmc>No</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>
        This clinical study will be conducted to determine the effects of musically accompanied&#xD;
        progressive muscle relaxation and deep breathing exercises on nursing students' stress levels&#xD;
        and bio-psycho-social responses to stress.&#xD;
  &#xD;
        Do musical progressive muscle relaxation and deep breathing exercises have an impact on&#xD;
        nursing students' stress levels and bio-psycho-social responses to stress?&#xD;
  &#xD;
        After students fill in the scales, they will be randomly assigned to the experimental and&#xD;
        control groups. The experimental group will be given progressive muscle relaxation and deep&#xD;
        breathing exercises accompanied by music once a week for six weeks by the researcher. There&#xD;
        will be no intervention in the control group. The scales will be reapplied to the&#xD;
        experimental and control groups in the week after the application is completed and two weeks&#xD;
        after the application is completed. Groups will be compared and statistical analyzes will be&#xD;
        made.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Stress is a psychosocial factor that affects students' academic performance and well-being.&#xD;
        The presence and level of stress have a positive or negative impact on learning and thinking,&#xD;
        and students show behavioral, emotional, and physical symptoms of experiencing stress For&#xD;
        this reason, it is very important for university students to apply stress reduction methods,&#xD;
        especially non-drug methods. Progressive relaxation and deep breathing exercises with music&#xD;
        are effective methods of coping with stress. When the literature is examined, it is seen that&#xD;
        the use of music has recently been effective in reducing the anxiety and stress experienced&#xD;
        by many students during the education process. At the same time, a progressive relaxation&#xD;
        exercise integrated with deep breathing exercises helps a person to feel the difference&#xD;
        between tension and laxity in the body and allows the person to learn to relax on their own,&#xD;
        thus reducing physical and emotional tension. Thus, the individual moves away from disturbing&#xD;
        stimuli that reduce the quality of life such as anxiety, pain, and stress. In accordance with&#xD;
        the nursing education program carried out with theoretical and practical application course&#xD;
        hours, students considering the stress they are exposed to and the behavioral, emotional, and&#xD;
        physical problems that arise with stress, there is a need for research that uses mind-body&#xD;
        applications to support nursing students. At the end of the research, it is foreseen that the&#xD;
        stress levels of nursing students and the symptoms seen due to stress can be reduced.&#xD;
  &#xD;
        Method: The universe of the study will consist of 2nd, 3rd, and 4th year nursing&#xD;
        undergraduate students who are studying and interning at Gülhane Nursing Faculty of Health&#xD;
        Sciences University in 2022-2023. As a result of the power analysis, the minimum sample size&#xD;
        was found to be 140 students, with 70 students in each group. During the study, in order to&#xD;
        strengthen the results of the research and increase reliability, it was determined that the&#xD;
        sample was 154 students with 77 experiments and 77 control groups with an increase of at&#xD;
        least 10%. Student sampling; After each class is evaluated as a layer, proportional&#xD;
        stratification will be taken by sampling method according to layer weight (number of&#xD;
        students). 44 students from 2nd grade, 52 students from 3rd grade, and 58 students from 4th&#xD;
        grade will participate in the research. Students have completed the Voluntary Consent Form&#xD;
        for Nursing Students, Personal Information Form, Perceived Stress, and Bio-psycho-social&#xD;
        Response Scale, then students who meet the inclusion criteria will be randomly assigned to&#xD;
        intervention and control groups. Exercises will be applied to the intervention groups for 6&#xD;
        weeks. There will be no intervention in the control group. At the end of 6 weeks and 2 weeks&#xD;
        after the last application (8. Weeks) intervention and control groups will refill the scales.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">October 3, 2022</start_date>
    <completion_date type="Anticipated">August 30, 2023</completion_date>
    <primary_completion_date type="Actual">June 2, 2023</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>
      <intervention_model_description>A comparison of the two groups to be assigned as experimental and control groups will be made.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Perceived Stress</measure>
      <time_frame>Scale; It is applied to all groups before the application starts, in the week when the application is completed (sixth week) and two weeks after the application is completed (eighth week).</time_frame>
      <description>The Perceived Stress Scale for Nursing Students scale is used to determine the level of stress that nursing students perceive in their clinical practice experiences.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Bio-psycho-social Response</measure>
      <time_frame>Scale; It is applied to all groups before the application starts, in the week when the application is completed (sixth week) and two weeks after the application is completed (eighth week).</time_frame>
      <description>The Bio-psycho-Social Response Scale for Nursing Students is used to determine the bio-psycho-social responses of nursing students to stress.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">154</enrollment>
    <condition>Stress</condition>
    <condition>Stress, Physiological</condition>
    <arm_group>
      <arm_group_label>Experimental Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Researcher will be applied progressive muscle relaxation and deep breathing exercises to the students in the experimental group. This practice will be applied to students once a week for six weeks. It will be ensured that the environment is quiet, at room temperature and dim. Students will take their places in chairs at an equal distance from each other. The researcher will be located in a place where his voice is heard by all students, and computers and speakers will be used for music. In addition, black eye patches will be distributed to students to use while exercising before starting the exercises. The muscle groups that are desired to be contracted and relaxed will be as follows (hands, arms, muscles in the face, tongue, head and neck muscles, shoulders, waist, abdominal leg muscles, and feet). At the same time, Lily's Theme which was selected by using the literature and expert opinion, will be played to the students together with the exercises.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>No intervention will be applied to the control group. They will be expected to refill the scales at the end of six weeks and on the eighth week for follow-up purposes.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Progressive Muscle Relaxation and Breathing Exercises</intervention_name>
      <description>Progressive relaxation exercise is a method that provides relaxation in the whole body by voluntary, regular relaxation of large muscle groups in the human body. Exercise helps individuals to be able to feel the difference between tension in the muscles and relaxation, and to learn to relax on their own in case of tension. Deep breathing exercise supports the maximum ventilation of the lung by correct breathing using the diaphragm.</description>
      <arm_group_label>Experimental Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  To be a nursing student who is studying at Gulhane Nursing Faculty of Health Sciences&#xD;
               University and going on internship&#xD;
  &#xD;
            -  Not to have any obstacles in oral and written communication in Turkish&#xD;
  &#xD;
            -  Volunteering to participate in research&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  If the student has a disease that prevents the relaxation exercise (Heart Failure,&#xD;
               Musculoskeletal System Problem, etc.)&#xD;
  &#xD;
            -  The student is participating in another relaxation program&#xD;
  &#xD;
            -  The student is taking a psychiatric medication that has a relaxing effect&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Çiğdem Yüksel</last_name>
      <role>Principal Investigator</role>
      <affiliation>Sağlık Bilimleri University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Sağlık Bilimleri University</name>
        <address>
          <city>Ankara</city>
          <zip>68105</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 12, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Progressive muscle exercises</keyword>
    <keyword>Breathing</keyword>
    <keyword>Stress</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Respiratory Aspiration</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06008236
  org study id: SBU-NK-01
  nct id: NCT06008236
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This clinical study will be conducted to determine the effects of musically accompanied
        progressive muscle relaxation and deep breathing exercises on nursing students' stress levels
        and bio-psycho-social responses to stress.
  
        Do musical progressive muscle relaxation and deep breathing exercises have an impact on
        nursing students' stress levels and bio-psycho-social responses to stress?
  
        After students fill in the scales, they will be randomly assigned to the experimental and
        control groups. The experimental group will be given progressive muscle relaxation and deep
        breathing exercises accompanied by music once a week for six weeks by the researcher. There
        will be no intervention in the control group. The scales will be reapplied to the
        experimental and control groups in the week after the application is completed and two weeks
        after the application is completed. Groups will be compared and statistical analyzes will be
        made.
  Stress is a psychosocial factor that affects students' academic performance and well-being.
        The presence and level of stress have a positive or negative impact on learning and thinking,
        and students show behavioral, emotional, and physical symptoms of experiencing stress For
        this reason, it is very important for university students to apply stress reduction methods,
        especially non-drug methods. Progressive relaxation and deep breathing exercises with music
        are effective methods of coping with stress. When the literature is examined, it is seen that
        the use of music has recently been effective in reducing the anxiety and stress experienced
        by many students during the education process. At the same time, a progressive relaxation
        exercise integrated with deep breathing exercises helps a person to feel the difference
        between tension and laxity in the body and allows the person to learn to relax on their own,
        thus reducing physical and emotional tension. Thus, the individual moves away from disturbing
        stimuli that reduce the quality of life such as anxiety, pain, and stress. In accordance with
        the nursing education program carried out with theoretical and practical application course
        hours, students considering the stress they are exposed to and the behavioral, emotional, and
        physical problems that arise with stress, there is a need for research that uses mind-body
        applications to support nursing students. At the end of the research, it is foreseen that the
        stress levels of nursing students and the symptoms seen due to stress can be reduced.
  
        Method: The universe of the study will consist of 2nd, 3rd, and 4th year nursing
        undergraduate students who are studying and interning at Gülhane Nursing Faculty of Health
        Sciences University in 2022-2023. As a result of the power analysis, the minimum sample size
        was found to be 140 students, with 70 students in each group. During the study, in order to
        strengthen the results of the research and increase reliability, it was determined that the
        sample was 154 students with 77 experiments and 77 control groups with an increase of at
        least 10%. Student sampling; After each class is evaluated as a layer, proportional
        stratification will be taken by sampling method according to layer weight (number of
        students). 44 students from 2nd grade, 52 students from 3rd grade, and 58 students from 4th
        grade will participate in the research. Students have completed the Voluntary Consent Form
        for Nursing Students, Personal Information Form, Perceived Stress, and Bio-psycho-social
        Response Scale, then students who meet the inclusion criteria will be randomly assigned to
        intervention and control groups. Exercises will be applied to the intervention groups for 6
        weeks. There will be no intervention in the control group. At the end of 6 weeks and 2 weeks
        after the last application (8. Weeks) intervention and control groups will refill the scales.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: A comparison of the two groups to be assigned as experimental and control groups will be made.
  primary purpose: Prevention
  masking: Single (Outcomes Assessor)
  measure: Perceived Stress
  time frame: Scale; It is applied to all groups before the application starts, in the week when the application is completed (sixth week) and two weeks after the application is completed (eighth week).
  description: The Perceived Stress Scale for Nursing Students scale is used to determine the level of stress that nursing students perceive in their clinical practice experiences.
  measure: Bio-psycho-social Response
  time frame: Scale; It is applied to all groups before the application starts, in the week when the application is completed (sixth week) and two weeks after the application is completed (eighth week).
  description: The Bio-psycho-Social Response Scale for Nursing Students is used to determine the bio-psycho-social responses of nursing students to stress.
  arm group label: Experimental Group
  arm group type: Experimental
  description: Researcher will be applied progressive muscle relaxation and deep breathing exercises to the students in the experimental group. This practice will be applied to students once a week for six weeks. It will be ensured that the environment is quiet, at room temperature and dim. Students will take their places in chairs at an equal distance from each other. The researcher will be located in a place where his voice is heard by all students, and computers and speakers will be used for music. In addition, black eye patches will be distributed to students to use while exercising before starting the exercises. The muscle groups that are desired to be contracted and relaxed will be as follows (hands, arms, muscles in the face, tongue, head and neck muscles, shoulders, waist, abdominal leg muscles, and feet). At the same time, Lily's Theme which was selected by using the literature and expert opinion, will be played to the students together with the exercises.
  arm group label: Control Group
  arm group type: No Intervention
  description: No intervention will be applied to the control group. They will be expected to refill the scales at the end of six weeks and on the eighth week for follow-up purposes.
  intervention type: Behavioral
  intervention name: Progressive Muscle Relaxation and Breathing Exercises
  description: Progressive relaxation exercise is a method that provides relaxation in the whole body by voluntary, regular relaxation of large muscle groups in the human body. Exercise helps individuals to be able to feel the difference between tension in the muscles and relaxation, and to learn to relax on their own in case of tension. Deep breathing exercise supports the maximum ventilation of the lung by correct breathing using the diaphragm.
  arm group label: Experimental Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Çiğdem Yüksel
  role: Principal Investigator
  affiliation: Sağlık Bilimleri University
  facility: 
  country: Turkey
  responsible party type: Sponsor
  mesh term: Respiratory Aspiration
  sharing ipd: No