<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/NCT02215486</url>
  </required_header>
  <id_info>
    <org_study_id>H13-03391</org_study_id>
    <nct_id>NCT02215486</nct_id>
  </id_info>
  <brief_title>The Effect of Head Massage Therapy on the Regulation of the Autonomic Nervous System</brief_title>
  <official_title>Head Massage Intervention to Decrease Physiological Signs of Stress as Assessed by Changes in the Autonomic Nervous System Functions in Healthy Volunteers: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's &amp; Women's Health Centre of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's &amp; Women's Health Centre of British Columbia</source>
  <brief_summary>
    <textblock>
      The autonomic nervous system (ANS) unconsciously regulates the activities of vital organ&#xD;
      systems such as the respiratory, circulatory, and urinary systems. It consists of two major&#xD;
      components, the parasympathetic nervous system (PNS) and the sympathetic nervous system&#xD;
      (SNS), which together are in charge of keeping our body in homeostasis. Homeostasis is the&#xD;
      state of chemical and metabolic balance within an organism; it is disturbed in situations of&#xD;
      uncontrolled stress.&#xD;
&#xD;
      Massage has been shown to decrease SNS and stimulate PNS; but most studies focused on full&#xD;
      body massage, with limited assessment of ANS function, and lacked control groups.&#xD;
&#xD;
      The effects of head massage therapy (HMT) on regulating the activity of the ANS have not been&#xD;
      studied before. In this pilot study, we propose that by randomizing 10 participants to&#xD;
      sessions of HMT and 'Simple Relaxation' (no HMT), and by using a non-invasive method of&#xD;
      measuring the ANS activity (spectral analysis of Heart Rate Variability [HRV] as well as&#xD;
      Pre-ejection Period (PEP)), we will be able to investigate the effects of 10 minutes of HMT&#xD;
      in comparison with the period of no HMT administered. We expect HMT to reduce stress, with a&#xD;
      better and balanced profile of autonomic nervous system after receiving massage.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2014</start_date>
  <primary_completion_date type="Actual">September 2014</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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Heart Rate Variability (HRV) parameters</measure>
    <time_frame>Within 1 day</time_frame>
    <description>Main HRV parameters that will be reported include High Frequency (HF) which is the power in high frequency range representative of the parasympathetic nervous system activity, HFnu which is the HF power in normalized units, and total power which is the total variability of the autonomic nervous system over the temporal segment.&#xD;
HRV parameters are measured at baseline and post intervention. Post-intervention outcomes for each subject will be compared with their baseline. There will also be comparison of the outcomes between the massage and the control intervention, for the effect of massage therapy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pre-ejection period (PEP)</measure>
    <time_frame>Within 1 day</time_frame>
    <description>PEP is the time interval between electrical stimulation of the sinoatrial node and opening of the aortic valves and has shown to be inversely correlated with the activity of the sympathetic nervous system.&#xD;
PEP is measured at baseline and post intervention. Post-intervention outcomes for each subject will be compared with their baseline. There will also be comparison of the outcomes between the massage and the control intervention, for the effect of massage therapy.</description>
  </primary_outcome>
  <enrollment type="Actual">10</enrollment>
  <condition>The Effect of Head Massage Therapy on the Autonomic Nervous System</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Head Massage Therapy</intervention_name>
    <description>Intervention consists of administering head massage therapy according to the Chinese head massage protocol for approximately 10 minutes.</description>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Simple relaxation (No Head Massage)</intervention_name>
    <description>Consists of a simple relaxation in the same sitting position as the head massage therapy session.</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Otherwise healthy individuals&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of anti-depressants or drugs that affect the cardiovascular system or ANS&#xD;
&#xD;
          -  Smoking more than 10 cigarettes/day&#xD;
&#xD;
          -  Inability to provide consent&#xD;
&#xD;
          -  Inability to speak and/or understand English&#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>Jean-Paul Collet, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's &amp; Women's Health Centre of British Columbia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mir Sohail Fazeli, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of British Columbia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>BC Children's and Women's Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6H 3N1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>August 9, 2014</study_first_submitted>
  <study_first_submitted_qc>August 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>May 26, 2015</last_update_submitted>
  <last_update_submitted_qc>May 26, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 28, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Children's &amp; Women's Health Centre of British Columbia</investigator_affiliation>
    <investigator_full_name>Jean-Paul Collet</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <keyword>Head massage therapy</keyword>
  <keyword>Massage therapy</keyword>
  <keyword>Autonomic nervous system (ANS)</keyword>
  <keyword>Heart rate variability (HRV)</keyword>
  <keyword>Pre-ejection period (PEP)</keyword>
  <!-- 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/NCT02215486
org study id: H13-03391
nct id: NCT02215486
lead sponsor: 
The autonomic nervous system (ANS) unconsciously regulates the activities of vital organ
      systems such as the respiratory, circulatory, and urinary systems. It consists of two major
      components, the parasympathetic nervous system (PNS) and the sympathetic nervous system
      (SNS), which together are in charge of keeping our body in homeostasis. Homeostasis is the
      state of chemical and metabolic balance within an organism; it is disturbed in situations of
      uncontrolled stress.

      Massage has been shown to decrease SNS and stimulate PNS; but most studies focused on full
      body massage, with limited assessment of ANS function, and lacked control groups.

      The effects of head massage therapy (HMT) on regulating the activity of the ANS have not been
      studied before. In this pilot study, we propose that by randomizing 10 participants to
      sessions of HMT and 'Simple Relaxation' (no HMT), and by using a non-invasive method of
      measuring the ANS activity (spectral analysis of Heart Rate Variability [HRV] as well as
      Pre-ejection Period (PEP)), we will be able to investigate the effects of 10 minutes of HMT
      in comparison with the period of no HMT administered. We expect HMT to reduce stress, with a
      better and balanced profile of autonomic nervous system after receiving massage.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Heart Rate Variability (HRV) parameters
time frame: Within 1 day
description: Main HRV parameters that will be reported include High Frequency (HF) which is the power in high frequency range representative of the parasympathetic nervous system activity, HFnu which is the HF power in normalized units, and total power which is the total variability of the autonomic nervous system over the temporal segment.
HRV parameters are measured at baseline and post intervention. Post-intervention outcomes for each subject will be compared with their baseline. There will also be comparison of the outcomes between the massage and the control intervention, for the effect of massage therapy
measure: Pre-ejection period (PEP)
time frame: Within 1 day
description: PEP is the time interval between electrical stimulation of the sinoatrial node and opening of the aortic valves and has shown to be inversely correlated with the activity of the sympathetic nervous system.
PEP is measured at baseline and post intervention. Post-intervention outcomes for each subject will be compared with their baseline. There will also be comparison of the outcomes between the massage and the control intervention, for the effect of massage therapy.
intervention type: Other
intervention name: Head Massage Therapy
description: Intervention consists of administering head massage therapy according to the Chinese head massage protocol for approximately 10 minutes.
intervention type: Other
intervention name: Simple relaxation (No Head Massage)
description: Consists of a simple relaxation in the same sitting position as the head massage therapy session.
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jean-Paul Collet, MD, PhD
role: Principal Investigator
affiliation: Children's & Women's Health Centre of British Columbia
last name: Mir Sohail Fazeli, M.D.
role: Principal Investigator
affiliation: The University of British Columbia
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Children's & Women's Health Centre of British Columbia
investigator full name: Jean-Paul Collet
investigator title: Director