<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/NCT04433637</url>
  </required_header>
  <id_info>
    <org_study_id>gulcin nacar</org_study_id>
    <nct_id>NCT04433637</nct_id>
  </id_info>
  <brief_title>Effect of Listed Music With Motivational Video And Nutrition on Non-Stress Test and Anxiety Level of Mother</brief_title>
  <acronym>NST</acronym>
  <official_title>Effect of Listed Music With Motivational Video And Nutrition on Non-Stress Test and Anxiety Level of Mother: Randomized Controlled Clinical Research</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Inonu University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Inonu University</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>
      Objective: The research was conducted to determine the effect of music and nutrition played&#xD;
      together with motivational video on non-stress test (NST) result and mother's anxiety level.&#xD;
&#xD;
      Method: The study was conducted as a randomized controlled clinical trial. The sample of the&#xD;
      study consisted of 360 pregnant women, two experimental and one control group (120 pregnant&#xD;
      women in each). In the study, pregnant women in the first experimental group were provided to&#xD;
      consume cake and fruit juice 30 minutes before the NST procedure. The second experimental&#xD;
      group was provided to eat fruit juice and cake before NST, and the video created with a&#xD;
      similar content was given about the developments and changes occurring in the mother and&#xD;
      fetus during pregnancy, and was watched for about 15-20 minutes during the NST procedure&#xD;
      accompanied by music that provided relaxation. The data of the study were collected by using&#xD;
      the Participant Presentation Form, NST evaluation form and State Anxiety Inventory.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Non Stress Test (NST) has been used frequently in fetal health assessment in recent years due&#xD;
      to its easy application, cheapness, reliability and rapid assessment. False negativity rates&#xD;
      of NST also cause an increase in cesarean rates. Studies in recent years show that there are&#xD;
      methods and factors that increase fetal movements and shorten NST application time. It was&#xD;
      observed that nutrient intake, music playing, fetal acoustic vibration application and&#xD;
      halogen light applications before NST increased fetal movements and shortened NST time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 25, 2018</start_date>
  <completion_date type="Actual">June 1, 2020</completion_date>
  <primary_completion_date type="Actual">July 11, 2019</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>Crossover Assignment</intervention_model>
    <intervention_model_description>Randomized controlled clinical trial</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effect of nutrition</measure>
    <time_frame>1 month</time_frame>
    <description>questionnaire NST Findings Registration Form&#xD;
As Reactive NST; The test result was accepted as reactive NST in the presence of at least two accelerations, which lasted at least 15 seconds within the 20-minute period when the electronic fetal heartbeat traces were printed and was 15 beats / minute more than the baseline beat.&#xD;
As nonreactive NST; The absence of at least two accelerations, which lasted at least 15 seconds within the 20-minute period when the electronic fetal heartbeat traces were printed, was 15 beats / minute more than the baseline beat, or 160 beats / minute and above continuous fetal tachycardia in the presence of severe variable decelerations and late decelerations. In case of development, the result was evaluated as nonreactive NST.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effect of music with motivational video</measure>
    <time_frame>1 month</time_frame>
    <description>scale State Anxiety Scale The state anxiety part of the scale consisting of two parts was used. Answer options on both scales consisting of twenty questions can get points from 1 to 4.&#xD;
There are direct and inverted expressions in the scales. Direct expressions express negative emotions, and reversed expressions express positive emotions. There are ten reversed expressions in the WHO and these are items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20. The total score value obtained from the scale varies between 20 and 80. The increase in the score obtained from the scale indicates that the level of anxiety is high.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">360</enrollment>
  <condition>Pregnancy Related</condition>
  <arm_group>
    <arm_group_label>Nutrition Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pregnant women in the first experimental group were provided to consume cake and fruit juice 30 minutes before the NST procedure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Video Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The video, which contains information about the developments and changes occurring in the mother and the fetus during pregnancy, was watched for 15-20 minutes during the NST procedure, accompanied by music that provided relaxation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention was applied to the pregnant women in the control group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Cake + fruit juice</intervention_name>
    <description>Cake+fruit juice experiment group, pregnant were allowed to consume fruit juice and cake, and it was expected that half an hour would pass after feeding to get NST.</description>
    <arm_group_label>Nutrition Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Video group</intervention_name>
    <description>Music with motivational video experimental group, pregnant women were provided with fruit juice and cake, and it was expected that half an hour would pass after feeding to get NST. During this waiting period, the researchers were informed about the development and changes in the body and the fetus specific to the gestational week and NST. Later, NST was applied, and during the procedure, the pregnant women were watched with music that provides relaxation with the video regarding the fetal development appropriate for the gestational week and changes in the mother.</description>
    <arm_group_label>Video Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Being 18 or over&#xD;
&#xD;
          -  Being pregnant more than 32 weeks gestation,&#xD;
&#xD;
          -  Having at least one live birth,&#xD;
&#xD;
          -  Having had NST before,&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Having any risk factor (preeclampsia, IUGG, early membrane rupture, getational&#xD;
             diabetes etc.) during pregnancy&#xD;
&#xD;
          -  Urinary contraction after NST,&#xD;
&#xD;
          -  It is a cardiovascular disease diagnosed in the fetus.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Pregnant women</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gülçin N NACAR, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>İnönü Üniversitesi</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Inonu University</name>
      <address>
        <city>Malatya</city>
        <state>Battalgazi</state>
        <zip>44280</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Taşhan ST, Çoşkun Eİ, Nacar G, Erci B. Effect of Listed Music With Motivational Video And Nutrition on Non-Stress Test and Anxiety Level of Mother: Randomized Controlled Clinical Research. Complementary Therapies in Medicine....</citation>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 16, 2020</last_update_submitted>
  <last_update_submitted_qc>June 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Inonu University</investigator_affiliation>
    <investigator_full_name>Gülçin NACAR</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Non Stress Test</keyword>
  <keyword>Motivational Video</keyword>
  <keyword>Music</keyword>
  <keyword>Nutrition</keyword>
  <keyword>State Anxiety</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04433637
org study id: gulcin nacar
nct id: NCT04433637
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Objective: The research was conducted to determine the effect of music and nutrition played
      together with motivational video on non-stress test (NST) result and mother's anxiety level.

      Method: The study was conducted as a randomized controlled clinical trial. The sample of the
      study consisted of 360 pregnant women, two experimental and one control group (120 pregnant
      women in each). In the study, pregnant women in the first experimental group were provided to
      consume cake and fruit juice 30 minutes before the NST procedure. The second experimental
      group was provided to eat fruit juice and cake before NST, and the video created with a
      similar content was given about the developments and changes occurring in the mother and
      fetus during pregnancy, and was watched for about 15-20 minutes during the NST procedure
      accompanied by music that provided relaxation. The data of the study were collected by using
      the Participant Presentation Form, NST evaluation form and State Anxiety Inventory.
Non Stress Test (NST) has been used frequently in fetal health assessment in recent years due
      to its easy application, cheapness, reliability and rapid assessment. False negativity rates
      of NST also cause an increase in cesarean rates. Studies in recent years show that there are
      methods and factors that increase fetal movements and shorten NST application time. It was
      observed that nutrient intake, music playing, fetal acoustic vibration application and
      halogen light applications before NST increased fetal movements and shortened NST time.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Randomized controlled clinical trial
primary purpose: Supportive Care
masking: Single (Participant)
measure: Effect of nutrition
time frame: 1 month
description: questionnaire NST Findings Registration Form
As Reactive NST; The test result was accepted as reactive NST in the presence of at least two accelerations, which lasted at least 15 seconds within the 20-minute period when the electronic fetal heartbeat traces were printed and was 15 beats / minute more than the baseline beat.
As nonreactive NST; The absence of at least two accelerations, which lasted at least 15 seconds within the 20-minute period when the electronic fetal heartbeat traces were printed, was 15 beats / minute more than the baseline beat, or 160 beats / minute and above continuous fetal tachycardia in the presence of severe variable decelerations and late decelerations. In case of development, the result was evaluated as nonreactive NST.
measure: Effect of music with motivational video
time frame: 1 month
description: scale State Anxiety Scale The state anxiety part of the scale consisting of two parts was used. Answer options on both scales consisting of twenty questions can get points from 1 to 4.
There are direct and inverted expressions in the scales. Direct expressions express negative emotions, and reversed expressions express positive emotions. There are ten reversed expressions in the WHO and these are items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20. The total score value obtained from the scale varies between 20 and 80. The increase in the score obtained from the scale indicates that the level of anxiety is high.
arm group label: Nutrition Group
arm group type: Experimental
description: Pregnant women in the first experimental group were provided to consume cake and fruit juice 30 minutes before the NST procedure.
arm group label: Video Group
arm group type: Experimental
description: The video, which contains information about the developments and changes occurring in the mother and the fetus during pregnancy, was watched for 15-20 minutes during the NST procedure, accompanied by music that provided relaxation.
arm group label: Control Group
arm group type: No Intervention
description: No intervention was applied to the pregnant women in the control group.
intervention type: Dietary Supplement
intervention name: Cake + fruit juice
description: Cake+fruit juice experiment group, pregnant were allowed to consume fruit juice and cake, and it was expected that half an hour would pass after feeding to get NST.
arm group label: Nutrition Group
intervention type: Other
intervention name: Video group
description: Music with motivational video experimental group, pregnant women were provided with fruit juice and cake, and it was expected that half an hour would pass after feeding to get NST. During this waiting period, the researchers were informed about the development and changes in the body and the fetus specific to the gestational week and NST. Later, NST was applied, and during the procedure, the pregnant women were watched with music that provides relaxation with the video regarding the fetal development appropriate for the gestational week and changes in the mother.
arm group label: Video Group
criteria: 
gender: Female
gender based: Yes
gender description: Pregnant women
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Gülçin N NACAR, PhD
role: Principal Investigator
affiliation: İnönü Üniversitesi
facility: 
country: Turkey
citation: Taşhan ST, Çoşkun Eİ, Nacar G, Erci B. Effect of Listed Music With Motivational Video And Nutrition on Non-Stress Test and Anxiety Level of Mother: Randomized Controlled Clinical Research. Complementary Therapies in Medicine....
responsible party type: Principal Investigator
investigator affiliation: Inonu University
investigator full name: Gülçin NACAR
investigator title: Principal Investigator
sharing ipd: No