<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/NCT03819166</url>
  </required_header>
  <id_info>
    <org_study_id>201012061RC</org_study_id>
    <nct_id>NCT03819166</nct_id>
  </id_info>
  <brief_title>Behavioral Support Techniques on Anxiety and Physical Reaction From Dental Treatment</brief_title>
  <official_title>The Effect of Behavioral Support Techniques on Anxiety and Physical Reaction From Dental Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</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>
      Application of deep touch pressure (DTP) has been suggested to provide positive effects on&#xD;
      anxiety modulation. However, empirical and theoretical evidence linked to the clinical&#xD;
      effects of DTP is relatively rare in the behavioral and physiological aspects. The aim of&#xD;
      this intervention trial study designs to investigate the effect of DTP in dental treatment by&#xD;
      quantitative analysis of behavioral assessments and physiological measurements, including the&#xD;
      electrodermal activity and heart rate variability, were conducted to understand the&#xD;
      modulation of the autonomic nervous system (ANS), the orchestration of sympathetic (SNS) and&#xD;
      parasympathetic (PsNS) nervous systems.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The subjects were recruited through word-of-mouth and by posted sign-up from the Department&#xD;
      of Dentistry, National Taiwan University Hospital (NTUH), Taiwan. Informed consent was&#xD;
      obtained prior to participation. The study protocol was approved by the Human Research Ethics&#xD;
      Committee of NTUH. Before the testing, the experimental protocol was explained to the&#xD;
      subjects. The subjects with normal overnight sleep quality were recruited to prevent the&#xD;
      influences in both physiological and physical fatigue. All potential subjects receive&#xD;
      independent examinations by an occupational therapist and a dentist to determine the&#xD;
      eligibility for inclusion as well as were blind to the study hypotheses. Both electrodermal&#xD;
      activity (EDA) and heart rate variability (HRV) were recorded continually through the entire&#xD;
      testing procedures. Since the EDA and HRV are sensitive indicators for autonomic nervous&#xD;
      system modulation, a standardization procedure that ensures the integrity of data is&#xD;
      accessed. The power of the testing is preset at 0.80, and the significant level is 0.05. The&#xD;
      quasi-experimental design of clinical trial for repeated measures will be used.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 11, 2011</start_date>
  <completion_date type="Anticipated">January 30, 2022</completion_date>
  <primary_completion_date type="Actual">July 18, 2013</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>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Heart Rate Variability (HRV)</measure>
    <time_frame>The baseline phase is defined as the five minutes before the dental treatment. The HRV data recorded in this phase will be considered as the baseline data of this study.</time_frame>
    <description>A non-invasive technique to investigate the effect of mental stress of the autonomic nervous system control on heart rate.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Electrodermal Activity (EDA)</measure>
    <time_frame>The baseline phase is defined as the five minutes before the dental treatment. The EAD data recorded in this phase will be considered as the baseline data of this study</time_frame>
    <description>A non-invasive technique to investigate the effect of mental stress of the sympathetic nervous system control on sweat gland of skin.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Heart Rate Variability (HRV)</measure>
    <time_frame>The treatment phase is the period of the entire procedures of dental treatment, approximate 40-90 minutes. The HRV data will be recorded to investigate the changes both during the dental treatment and in the application of deep touch pressure.</time_frame>
    <description>A non-invasive technique to investigate the effect of mental stress of the autonomic nervous system control on heart rate.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Electrodermal Activity (EDA)</measure>
    <time_frame>The treatment phase is the period of the entire procedures of dental treatment, approximate 40-90 minutes. The EDA data will be recorded to investigate the changes both during the dental treatment and in the application of deep touch pressure.</time_frame>
    <description>A non-invasive technique to investigate the effect of mental stress of the sympathetic nervous system control on sweat gland of skin.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Heart Rate Variability (HRV)</measure>
    <time_frame>The post-treatment phase is defined as the five minutes after the dental treatment. The HRV data recorded in this phase will be considered as the post-treatment data which used to compare to the baseline and treatment data.</time_frame>
    <description>A non-invasive technique to investigate the effect of mental stress of the autonomic nervous system control on heart rate.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Electrodermal Activity (EDA)</measure>
    <time_frame>The post-treatment phase is defined as the five minutes after the dental treatment. The EDA data recorded in this phase will be considered as the post-treatment data which used to compare to the baseline and treatment data.</time_frame>
    <description>A non-invasive technique to investigate the effect of mental stress of the sympathetic nervous system control on sweat gland of skin.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dental Anxiety Scale (DAS)</measure>
    <time_frame>This questionnaire will be applied in the baseline phase (immediately after HRV measurement and about 5 minutes before dental procedures) to know anxiety condition of participants before the dental treatment.</time_frame>
    <description>This questionnaire can range from 4 (not anxious at all) to 20 (extremely anxious).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dental Anxiety Scale (DAS)</measure>
    <time_frame>The averaged time of dental treatment is about 40-90 minutes.This questionnaire will be applied immediately after the dental treatment completion.</time_frame>
    <description>This questionnaire can range from 4 (not anxious at all) to 20 (extremely anxious).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numeric State Anxiety Scale (NSAS)</measure>
    <time_frame>This scale will be scored in the baseline phase (immediately after HRV measurement and about 5 minutes before dental procedures) to identify the anxiety state of participants before the dental treatment.</time_frame>
    <description>This ordinal scale, range from 0-10, which is represented as a abscissa line to reflect the level of anxiety; 0 and 1 is not at all, 2 to 4 is little, 5 to 7 is medium, 8 and 9 is a lot, and 10 is worst imaginable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numeric State Anxiety Scale (NSAS)</measure>
    <time_frame>The averaged time of dental treatment is about 40-90 minutes.This scale will be scored immediately after the dental treatment completion.</time_frame>
    <description>This ordinal scale, range from 0-10, which is represented as a abscissa line to reflect the level of anxiety; 0 and 1 is not at all, 2 to 4 is little, 5 to 7 is medium, 8 and 9 is a lot, and 10 is worst imaginable.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Dental Anxiety</condition>
  <condition>Dental Diseases</condition>
  <condition>Dental Trauma</condition>
  <arm_group>
    <arm_group_label>experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participants recruited in the group will receive the input of deep touch pressure during their procedures of dental treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>The participants recruited in the group will not receive the input of deep touch pressure during their procedures of dental treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>with deep touch pressure application</intervention_name>
    <description>The deep touch pressure is applied by the weight loading devices, including but not limited to, weight blanket and weight vest.</description>
    <arm_group_label>experimental group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>without deep touch pressure application</intervention_name>
    <description>The deep touch pressure will not be applied.</description>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who requiring tooth extraction were potentially selected to recruit.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  with a history of systemic diseases that would contraindicate surgical treatment&#xD;
&#xD;
          -  pregnant and lactating&#xD;
&#xD;
          -  smoking of more than 10 cigarettes per day&#xD;
&#xD;
          -  poor overnight sleep quality&#xD;
&#xD;
          -  refusal to sign the inform consent agreement&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hsiagn Yang, DDS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Dentistry, National Taiwan University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hsiang Yang, DDS</last_name>
    <phone>+886-2-2312345</phone>
    <phone_ext>70478</phone_ext>
    <email>dtdent90@yahoo.com.tw</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hsin-Ming Chen, DDS, PhD</last_name>
    <phone>+886-2-3123456</phone>
    <phone_ext>67709</phone_ext>
    <email>hsinmingchen@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hsiang Yang, DDS</last_name>
      <phone>+886-2-3123456</phone>
      <phone_ext>70478</phone_ext>
      <email>dtdent90@yahoo.com.tw</email>
    </contact>
    <contact_backup>
      <last_name>Hsin-Ming Chen, DDS, PhD</last_name>
      <phone>+886-2-3123456</phone>
      <phone_ext>67709</phone_ext>
      <email>hsinmingchen@hotmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Hsiang Yang, DDS</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>January 13, 2021</last_update_submitted>
  <last_update_submitted_qc>January 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomatognathic Diseases</mesh_term>
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is not a plan to make IPD available.</ipd_description>
  </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/NCT03819166
org study id: 201012061RC
nct id: NCT03819166
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Application of deep touch pressure (DTP) has been suggested to provide positive effects on
      anxiety modulation. However, empirical and theoretical evidence linked to the clinical
      effects of DTP is relatively rare in the behavioral and physiological aspects. The aim of
      this intervention trial study designs to investigate the effect of DTP in dental treatment by
      quantitative analysis of behavioral assessments and physiological measurements, including the
      electrodermal activity and heart rate variability, were conducted to understand the
      modulation of the autonomic nervous system (ANS), the orchestration of sympathetic (SNS) and
      parasympathetic (PsNS) nervous systems.
The subjects were recruited through word-of-mouth and by posted sign-up from the Department
      of Dentistry, National Taiwan University Hospital (NTUH), Taiwan. Informed consent was
      obtained prior to participation. The study protocol was approved by the Human Research Ethics
      Committee of NTUH. Before the testing, the experimental protocol was explained to the
      subjects. The subjects with normal overnight sleep quality were recruited to prevent the
      influences in both physiological and physical fatigue. All potential subjects receive
      independent examinations by an occupational therapist and a dentist to determine the
      eligibility for inclusion as well as were blind to the study hypotheses. Both electrodermal
      activity (EDA) and heart rate variability (HRV) were recorded continually through the entire
      testing procedures. Since the EDA and HRV are sensitive indicators for autonomic nervous
      system modulation, a standardization procedure that ensures the integrity of data is
      accessed. The power of the testing is preset at 0.80, and the significant level is 0.05. The
      quasi-experimental design of clinical trial for repeated measures will be used.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Participant)
measure: Heart Rate Variability (HRV)
time frame: The baseline phase is defined as the five minutes before the dental treatment. The HRV data recorded in this phase will be considered as the baseline data of this study.
description: A non-invasive technique to investigate the effect of mental stress of the autonomic nervous system control on heart rate.
measure: Electrodermal Activity (EDA)
time frame: The baseline phase is defined as the five minutes before the dental treatment. The EAD data recorded in this phase will be considered as the baseline data of this study
description: A non-invasive technique to investigate the effect of mental stress of the sympathetic nervous system control on sweat gland of skin.
measure: Heart Rate Variability (HRV)
time frame: The treatment phase is the period of the entire procedures of dental treatment, approximate 40-90 minutes. The HRV data will be recorded to investigate the changes both during the dental treatment and in the application of deep touch pressure.
description: A non-invasive technique to investigate the effect of mental stress of the autonomic nervous system control on heart rate.
measure: Electrodermal Activity (EDA)
time frame: The treatment phase is the period of the entire procedures of dental treatment, approximate 40-90 minutes. The EDA data will be recorded to investigate the changes both during the dental treatment and in the application of deep touch pressure.
description: A non-invasive technique to investigate the effect of mental stress of the sympathetic nervous system control on sweat gland of skin.
measure: Heart Rate Variability (HRV)
time frame: The post-treatment phase is defined as the five minutes after the dental treatment. The HRV data recorded in this phase will be considered as the post-treatment data which used to compare to the baseline and treatment data.
description: A non-invasive technique to investigate the effect of mental stress of the autonomic nervous system control on heart rate.
measure: Electrodermal Activity (EDA)
time frame: The post-treatment phase is defined as the five minutes after the dental treatment. The EDA data recorded in this phase will be considered as the post-treatment data which used to compare to the baseline and treatment data.
description: A non-invasive technique to investigate the effect of mental stress of the sympathetic nervous system control on sweat gland of skin.
measure: Dental Anxiety Scale (DAS)
time frame: This questionnaire will be applied in the baseline phase (immediately after HRV measurement and about 5 minutes before dental procedures) to know anxiety condition of participants before the dental treatment.
description: This questionnaire can range from 4 (not anxious at all) to 20 (extremely anxious).
measure: Dental Anxiety Scale (DAS)
time frame: The averaged time of dental treatment is about 40-90 minutes.This questionnaire will be applied immediately after the dental treatment completion.
description: This questionnaire can range from 4 (not anxious at all) to 20 (extremely anxious).
measure: Numeric State Anxiety Scale (NSAS)
time frame: This scale will be scored in the baseline phase (immediately after HRV measurement and about 5 minutes before dental procedures) to identify the anxiety state of participants before the dental treatment.
description: This ordinal scale, range from 0-10, which is represented as a abscissa line to reflect the level of anxiety; 0 and 1 is not at all, 2 to 4 is little, 5 to 7 is medium, 8 and 9 is a lot, and 10 is worst imaginable.
measure: Numeric State Anxiety Scale (NSAS)
time frame: The averaged time of dental treatment is about 40-90 minutes.This scale will be scored immediately after the dental treatment completion.
description: This ordinal scale, range from 0-10, which is represented as a abscissa line to reflect the level of anxiety; 0 and 1 is not at all, 2 to 4 is little, 5 to 7 is medium, 8 and 9 is a lot, and 10 is worst imaginable.
arm group label: experimental group
arm group type: Experimental
description: The participants recruited in the group will receive the input of deep touch pressure during their procedures of dental treatment.
arm group label: control group
arm group type: Sham Comparator
description: The participants recruited in the group will not receive the input of deep touch pressure during their procedures of dental treatment.
intervention type: Device
intervention name: with deep touch pressure application
description: The deep touch pressure is applied by the weight loading devices, including but not limited to, weight blanket and weight vest.
arm group label: experimental group
intervention type: Device
intervention name: without deep touch pressure application
description: The deep touch pressure will not be applied.
arm group label: control group
criteria: 
gender: All
minimum age: 10 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hsiagn Yang, DDS
role: Principal Investigator
affiliation: Department of Dentistry, National Taiwan University Hospital
last name: Hsiang Yang, DDS
phone: +886-2-2312345
phone ext: 70478
email: dtdent90@yahoo.com.tw
last name: Hsin-Ming Chen, DDS, PhD
phone: +886-2-3123456
phone ext: 67709
email: hsinmingchen@hotmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Taiwan
responsible party type: Sponsor
mesh term: Stomatognathic Diseases
mesh term: Anxiety Disorders
sharing ipd: No
ipd description: There is not a plan to make IPD available.