<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/NCT04409938</url>
  </required_header>
  <id_info>
    <org_study_id>121</org_study_id>
    <nct_id>NCT04409938</nct_id>
  </id_info>
  <brief_title>Progressive Muscle Relaxation and Nature Sounds in Nursing Students</brief_title>
  <official_title>The Effect of Progressive Muscle Relaxation and Nature Sounds on Blood Pressure Measurement Skills, Anxiety Levels, and Vital Signs in Nursing Students</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>TC Erciyes University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>TC Erciyes University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: The aim of this study was to determine the effect of PMR and nature sounds on&#xD;
      nursing students' BPM skills, and anxiety levels and vital signs.&#xD;
&#xD;
      Methods: This was a randomized controlled experimental study conducted at the nursing&#xD;
      department of the faculty of health sciences of a university. PMR participants rested for ten&#xD;
      minutes between the sessions and then practiced PMR for 15 minutes. PMR+NS participants&#xD;
      practiced PMR accompanied by nature sounds.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: The aim of this study was to determine the effect of PMR and nature sounds on&#xD;
      nursing students' BPM skills, and anxiety levels and vital signs.&#xD;
&#xD;
      Methods: This was a randomized controlled experimental study conducted at the nursing&#xD;
      department of the faculty of health sciences of a university. PMR participants rested for ten&#xD;
      minutes between the sessions and then practiced PMR for 15 minutes. PMR consisted of taking a&#xD;
      deep breath five times and then clenching fists, raising the shoulders, bringing the forearms&#xD;
      towards the body, stretching the triceps muscle, and tensing and relaxing the forehead, eye,&#xD;
      chin, neck, chest, abdomen, back, hips, thigh, and feet muscles. The investigators made a&#xD;
      video of exercises in a certain order and uploaded it to the television in the lab prior to&#xD;
      the intervention. The investigators turned on the video during the intervention and asked the&#xD;
      participants to follow the instructions for PMR exercises. PMR+NS participants practiced PMR&#xD;
      accompanied by nature sounds.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 3, 2020</start_date>
  <completion_date type="Actual">February 28, 2020</completion_date>
  <primary_completion_date type="Actual">February 3, 2020</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The State-Trait Anxiety Inventory (STAI)</measure>
    <time_frame>pre-intervention</time_frame>
    <description>The STAI consists of two parts; the State Anxiety Inventory (SAI) and the Trait Anxiety Inventory (TAI). The SAI measures anxiety about an event while the TAI measures anxiety level as a personal characteristic. The TAI and SAI each consists of 20 items. The SAI items are scored on a 4-point Likert scale of 1 to 4 (1= never, 2= sometimes, 3= often, 4= always). The SAI items are scored on a 4-point Likert scale of 1 to 4 (1= almost never, 2= sometimes, 3= often, 4= almost always). Ten SAI items (1, 2, 5, 8, 10, 11, 15, 16, 19, and 20) and six TAI items (1, 6, 7, 13, 16, and 19) are reverse scored. Higher scores indicate greater anxiety.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The State Anxiety Inventory (SAI)</measure>
    <time_frame>through study completion for each group, an average of 4 hour</time_frame>
    <description>The SAI items are scored on a 4-point Likert scale of 1 to 4 (1= almost never, 2= sometimes, 3= often, 4= almost always). Ten SAI items (1, 2, 5, 8, 10, 11, 15, 16, 19, and 20) and six TAI items (1, 6, 7, 13, 16, and 19) are reverse scored. Higher scores indicate greater anxiety</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Blood Pressure Knowledge Test (BPKT)</measure>
    <time_frame>through study completion for each group, an average of 4 hour</time_frame>
    <description>BPKT is a multiple-choice test consisting of 20 items on definitions, physiology, affecting factors, classification, measurement sites, planning, application auscultation/ palpation measurement, and evaluation. A correct response is scored 1, and therefore, the total score ranges from 0 to 20.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">127</enrollment>
  <condition>Anxiety</condition>
  <arm_group>
    <arm_group_label>Progressive Muscle Relaxation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PMR participants rested for ten minutes between the sessions and then practiced PMR for 15 minutes. PMR consisted of taking a deep breath five times and then clenching fists, raising the shoulders, bringing the forearms towards the body, stretching the triceps muscle, and tensing and relaxing the forehead, eye, chin, neck, chest, abdomen, back, hips, thigh, and feet muscles. The investigators made a video of exercises in a certain order and uploaded it to the television in the lab prior to the intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Progressive Muscle Relaxation with Nature Sounds</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PMR+NS participants practiced PMR accompanied by nature sounds.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Practice</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The standard practice of the lab was made.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Progressive Muscle Relaxation</intervention_name>
    <description>PMR participants rested for ten minutes between the sessions and then practiced PMR for 15 minutes. PMR consisted of taking a deep breath five times and then clenching fists, raising the shoulders, bringing the forearms towards the body, stretching the triceps muscle, and tensing and relaxing the forehead, eye, chin, neck, chest, abdomen, back, hips, thigh, and feet muscles. The investigators made a video of exercises in a certain order and uploaded it to the television in the lab prior to the intervention. The investigators turned on the video during the intervention and asked the participants to follow the instructions for PMR exercises.</description>
    <arm_group_label>Progressive Muscle Relaxation</arm_group_label>
    <arm_group_label>Progressive Muscle Relaxation with Nature Sounds</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nature Sounds</intervention_name>
    <description>PMR+NS participants practiced PMR accompanied by nature sounds. PMR consisted of taking a deep breath five times and then clenching fists, raising the shoulders, bringing the forearms towards the body, stretching the triceps muscle, and tensing and relaxing the forehead, eye, chin, neck, chest, abdomen, back, hips, thigh, and feet muscles. The investigators made a video of exercises in a certain order and uploaded it to the television in the lab prior to the intervention. The investigators turned on the video during the intervention and asked the participants to follow the instructions for PMR exercises.</description>
    <arm_group_label>Progressive Muscle Relaxation with Nature Sounds</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. being a first-year nursing student&#xD;
&#xD;
          2. voluntary&#xD;
&#xD;
          3. participating in the theoretical part of the &quot;Pulse and Blood Pressure Measurement&quot;&#xD;
             course and in lab practice.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  not participating in the theoretical part of the &quot;Pulse and Blood Pressure&#xD;
             Measurement&quot; course and in lab practice.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sevda Korkut, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>TC Erciyes University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Erciyes University</name>
      <address>
        <city>Kayseri</city>
        <zip>38039</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>August 28, 2020</last_update_submitted>
  <last_update_submitted_qc>August 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>TC Erciyes University</investigator_affiliation>
    <investigator_full_name>Sevda Korkut</investigator_full_name>
    <investigator_title>Principal Inverstigator</investigator_title>
  </responsible_party>
  <keyword>Skill training</keyword>
  <keyword>Nursing students</keyword>
  <keyword>Anxiety</keyword>
  <keyword>Blood Pressure Measurement Skills</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <!-- 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/NCT04409938
org study id: 121
nct id: NCT04409938
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Background: The aim of this study was to determine the effect of PMR and nature sounds on
      nursing students' BPM skills, and anxiety levels and vital signs.

      Methods: This was a randomized controlled experimental study conducted at the nursing
      department of the faculty of health sciences of a university. PMR participants rested for ten
      minutes between the sessions and then practiced PMR for 15 minutes. PMR+NS participants
      practiced PMR accompanied by nature sounds.
Background: The aim of this study was to determine the effect of PMR and nature sounds on
      nursing students' BPM skills, and anxiety levels and vital signs.

      Methods: This was a randomized controlled experimental study conducted at the nursing
      department of the faculty of health sciences of a university. PMR participants rested for ten
      minutes between the sessions and then practiced PMR for 15 minutes. PMR consisted of taking a
      deep breath five times and then clenching fists, raising the shoulders, bringing the forearms
      towards the body, stretching the triceps muscle, and tensing and relaxing the forehead, eye,
      chin, neck, chest, abdomen, back, hips, thigh, and feet muscles. The investigators made a
      video of exercises in a certain order and uploaded it to the television in the lab prior to
      the intervention. The investigators turned on the video during the intervention and asked the
      participants to follow the instructions for PMR exercises. PMR+NS participants practiced PMR
      accompanied by nature sounds.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: The State-Trait Anxiety Inventory (STAI)
time frame: pre-intervention
description: The STAI consists of two parts; the State Anxiety Inventory (SAI) and the Trait Anxiety Inventory (TAI). The SAI measures anxiety about an event while the TAI measures anxiety level as a personal characteristic. The TAI and SAI each consists of 20 items. The SAI items are scored on a 4-point Likert scale of 1 to 4 (1= never, 2= sometimes, 3= often, 4= always). The SAI items are scored on a 4-point Likert scale of 1 to 4 (1= almost never, 2= sometimes, 3= often, 4= almost always). Ten SAI items (1, 2, 5, 8, 10, 11, 15, 16, 19, and 20) and six TAI items (1, 6, 7, 13, 16, and 19) are reverse scored. Higher scores indicate greater anxiety.
measure: The State Anxiety Inventory (SAI)
time frame: through study completion for each group, an average of 4 hour
description: The SAI items are scored on a 4-point Likert scale of 1 to 4 (1= almost never, 2= sometimes, 3= often, 4= almost always). Ten SAI items (1, 2, 5, 8, 10, 11, 15, 16, 19, and 20) and six TAI items (1, 6, 7, 13, 16, and 19) are reverse scored. Higher scores indicate greater anxiety
measure: The Blood Pressure Knowledge Test (BPKT)
time frame: through study completion for each group, an average of 4 hour
description: BPKT is a multiple-choice test consisting of 20 items on definitions, physiology, affecting factors, classification, measurement sites, planning, application auscultation/ palpation measurement, and evaluation. A correct response is scored 1, and therefore, the total score ranges from 0 to 20.
arm group label: Progressive Muscle Relaxation
arm group type: Experimental
description: PMR participants rested for ten minutes between the sessions and then practiced PMR for 15 minutes. PMR consisted of taking a deep breath five times and then clenching fists, raising the shoulders, bringing the forearms towards the body, stretching the triceps muscle, and tensing and relaxing the forehead, eye, chin, neck, chest, abdomen, back, hips, thigh, and feet muscles. The investigators made a video of exercises in a certain order and uploaded it to the television in the lab prior to the intervention.
arm group label: Progressive Muscle Relaxation with Nature Sounds
arm group type: Experimental
description: PMR+NS participants practiced PMR accompanied by nature sounds.
arm group label: Standard Practice
arm group type: No Intervention
description: The standard practice of the lab was made.
intervention type: Other
intervention name: Progressive Muscle Relaxation
description: PMR participants rested for ten minutes between the sessions and then practiced PMR for 15 minutes. PMR consisted of taking a deep breath five times and then clenching fists, raising the shoulders, bringing the forearms towards the body, stretching the triceps muscle, and tensing and relaxing the forehead, eye, chin, neck, chest, abdomen, back, hips, thigh, and feet muscles. The investigators made a video of exercises in a certain order and uploaded it to the television in the lab prior to the intervention. The investigators turned on the video during the intervention and asked the participants to follow the instructions for PMR exercises.
arm group label: Progressive Muscle Relaxation
arm group label: Progressive Muscle Relaxation with Nature Sounds
intervention type: Other
intervention name: Nature Sounds
description: PMR+NS participants practiced PMR accompanied by nature sounds. PMR consisted of taking a deep breath five times and then clenching fists, raising the shoulders, bringing the forearms towards the body, stretching the triceps muscle, and tensing and relaxing the forehead, eye, chin, neck, chest, abdomen, back, hips, thigh, and feet muscles. The investigators made a video of exercises in a certain order and uploaded it to the television in the lab prior to the intervention. The investigators turned on the video during the intervention and asked the participants to follow the instructions for PMR exercises.
arm group label: Progressive Muscle Relaxation with Nature Sounds
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Sevda Korkut, PhD
role: Principal Investigator
affiliation: TC Erciyes University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: TC Erciyes University
investigator full name: Sevda Korkut
investigator title: Principal Inverstigator
mesh term: Anxiety Disorders