<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/NCT02247089</url>
  </required_header>
  <id_info>
    <org_study_id>H13-01584</org_study_id>
    <nct_id>NCT02247089</nct_id>
  </id_info>
  <brief_title>The Effect of Massage Therapy to Control Night Shift Related Stress</brief_title>
  <official_title>The Effect of Massage Therapy to Control Night Shift Related Stress: A Pilot Prospective Randomized Crossover Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Registered Massage Therapists Association of British Columbia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of British Columbia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      The sympathetic and parasympathetic branches (SNS and PNS) of the autonomic nervous system&#xD;
      (ANS), keep our body in a state of balance, which can be disturbed in situations of&#xD;
      uncontrolled stress. Sleep deprivation and specifically night shift is a source of stress&#xD;
      with adverse consequences on sleep, wakefulness, eating patterns and cardio-vascular&#xD;
      function. Furthermore, imbalanced autonomic profile is also associated with increased&#xD;
      inflammation, a known risk factor for cardiac problems, diabetes, and cancer.&#xD;
&#xD;
      Parasympathetic stimulation can control the inflammatory reaction, leading research toward&#xD;
      interventions which can stimulate the cholinergic pathway. Among these interventions, massage&#xD;
      therapy has shown to stimulate the PNS and bring back the balance within the body's organs.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
        1. To assess the physiological effects of night shifts on the ANS profile and bio-markers&#xD;
           of inflammation and stress in blood&#xD;
&#xD;
        2. To assess whether one session of massage therapy can revert the adverse effects of night&#xD;
           shift via re-balancing these components.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      A pilot prospective randomized crossover trial with 10 healthy hospital staff is in progress:&#xD;
&#xD;
      Each participants will be their own control. All participants will be measured for their&#xD;
      baseline characteristics and outcomes of interest on a regular working day as well as at the&#xD;
      end of 2 nights of shift work. At the end of one shift they will be randomly assigned to&#xD;
      receive a 30-minute-long &quot;upper body massage&quot;, while at the end of the other shift they will&#xD;
      receive a &quot;reading intervention&quot; which would serve as a control intervention. Randomization&#xD;
      is done using a computer system that also verifies inclusion-exclusion criteria before&#xD;
      allocating the intervention.&#xD;
&#xD;
      The autonomic profile is measured by spectral analysis of Heart Rate Variability (HRV)&#xD;
      captured by a state-of-the-art machine which non-invasively records electrical signals from&#xD;
      the body. The inflammatory markers in the blood are also measured using top-notch laboratory&#xD;
      technology.&#xD;
&#xD;
      The results of the study will be reported by comparing the outcomes of each subject with&#xD;
      their own baseline as well as comparing the two interventions for the effect of massage. Data&#xD;
      will be pooled for all subjects in order to show the overall effect.&#xD;
&#xD;
      The final results of this study will be used to plan stress management intervention trials.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2014</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</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>up to 1 month</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;
The HRV parameters will be measured at 5 different time points all at approximately the same time in the morning. These 5 time points are as follows:&#xD;
Baseline measurement: This measurement takes place on a regular working day with no night shift at the end of the day or the night before.&#xD;
Shift measurements (Pre-intervention): These consist of measurements before interventions at the end of two separate nights of shift work.&#xD;
Post-intervention measurements: These consist of measurements after interventions at the end of two separate nights of shift work.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pre-ejection period (PEP)</measure>
    <time_frame>up to 1 month</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 will be measured at 5 different time points all at approximately the same time in the morning. These 5 time points are as follows:&#xD;
Baseline measurement: This measurement takes place on a regular working day with no night shift at the end of the day or the night before.&#xD;
Shift measurements (Pre-intervention): These consist of measurements before interventions at the end of two separate nights of shift work.&#xD;
Post-intervention measurements: These consist of measurements after interventions at the end of two separate nights of shift work.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pro-inflammatory cytokines</measure>
    <time_frame>5 times within 1 month</time_frame>
    <description>These consist of protein and mRNA levels of secreted pro-inflammatory cytokines (IL-6, IL-1beta and TNF-alpha) in blood.&#xD;
The pro-inflammatory cytokines will be measured at 5 different time points all at approximately the same time in the morning. These 5 time points are as follows:&#xD;
Baseline measurement: This measurement takes place on a regular working day with no night shift at the end of the day or the night before.&#xD;
Shift measurements (Pre-intervention): These consist of measurements before interventions at the end of two separate nights of shift work.&#xD;
Post-intervention measurements: These consist of measurements after interventions at the end of two separate nights of shift work.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Cortisol level</measure>
    <time_frame>5 times within 1 month</time_frame>
    <description>The plasma cortisol level will be measured at 5 different time points all at approximately the same time in the morning. These 5 time points are as follows:&#xD;
Baseline measurement: This measurement takes place on a regular working day with no night shift at the end of the day or the night before.&#xD;
Shift measurements (Pre-intervention): These consist of measurements before interventions at the end of two separate nights of shift work.&#xD;
Post-intervention measurements: These consist of measurements after interventions at the end of two separate nights of shift work.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Blood Pressure</measure>
    <time_frame>5 times within 1 month</time_frame>
    <description>Systolic and diastolic Blood pressure will be measure at 5 different time points all at approximately the same time in the morning. These 5 time points are as follows:&#xD;
Baseline measurement: This measurement takes place on a regular working day with no night shift at the end of the day or the night before.&#xD;
Shift measurements (Pre-intervention): These consist of measurements before interventions at the end of two separate nights of shift work.&#xD;
Post-intervention measurements: These consist of measurements after interventions at the end of two separate nights of shift work.</description>
  </other_outcome>
  <other_outcome>
    <measure>Heart Rate</measure>
    <time_frame>5 times within 1 month</time_frame>
    <description>Average of beat to beat heart rate (in beats per minute) will be measured at 5 different time points all at approximately the same time in the morning. These 5 time points are as follows:&#xD;
Baseline measurement: This measurement takes place on a regular working day with no night shift at the end of the day or the night before.&#xD;
Shift measurements (Pre-intervention): These consist of measurements before interventions at the end of two separate nights of shift work.&#xD;
Post-intervention measurements: These consist of measurements after interventions at the end of two separate nights of shift work.</description>
  </other_outcome>
  <enrollment type="Actual">12</enrollment>
  <condition>Stress</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Massage Therapy</intervention_name>
    <description>Intervention consists of administering a 30-minute-long upper body massage by a registered massage therapist following a massage protocol developed by Vancouver College of Massage Therapy (VCMT).</description>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Journal reading (No massage therapy)</intervention_name>
    <description>Intervention consists of journal reading in the same sitting position as the massage therapy session for approximately 30 minutes.</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Otherwise healthy hospital staff between the ages of 20 to 60 taking rotating night&#xD;
             shifts on a regular basis.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants who are on anti-depressants or drugs that affect the cardiovascular&#xD;
             system or the ANS.&#xD;
&#xD;
          -  Any conditions or disorders that would affect the cardiovascular system or the&#xD;
             activity of the ANS.&#xD;
&#xD;
          -  Participants who smoke 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>20 Years</minimum_age>
    <maximum_age>60 Years</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, MD, PhD Candidate</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>October 2017</verification_date>
  <study_first_submitted>September 10, 2014</study_first_submitted>
  <study_first_submitted_qc>September 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 23, 2014</study_first_posted>
  <last_update_submitted>October 24, 2017</last_update_submitted>
  <last_update_submitted_qc>October 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of British Columbia</investigator_affiliation>
    <investigator_full_name>Mir Sohail Fazeli</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <keyword>Night Shift work</keyword>
  <keyword>Stress</keyword>
  <keyword>Autonomic nervous system (ANS)</keyword>
  <keyword>Heart rate variability (HRV)</keyword>
  <keyword>Pre-ejection period (PEP)</keyword>
  <keyword>Inflammation</keyword>
  <keyword>Pro-inflammatory cytokines</keyword>
  <keyword>Massage Therapy</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/NCT02247089
org study id: H13-01584
nct id: NCT02247089
lead sponsor: 
collaborator: 
has dmc: No
Background:

      The sympathetic and parasympathetic branches (SNS and PNS) of the autonomic nervous system
      (ANS), keep our body in a state of balance, which can be disturbed in situations of
      uncontrolled stress. Sleep deprivation and specifically night shift is a source of stress
      with adverse consequences on sleep, wakefulness, eating patterns and cardio-vascular
      function. Furthermore, imbalanced autonomic profile is also associated with increased
      inflammation, a known risk factor for cardiac problems, diabetes, and cancer.

      Parasympathetic stimulation can control the inflammatory reaction, leading research toward
      interventions which can stimulate the cholinergic pathway. Among these interventions, massage
      therapy has shown to stimulate the PNS and bring back the balance within the body's organs.

      Objectives:

        1. To assess the physiological effects of night shifts on the ANS profile and bio-markers
           of inflammation and stress in blood

        2. To assess whether one session of massage therapy can revert the adverse effects of night
           shift via re-balancing these components.

      Methods:

      A pilot prospective randomized crossover trial with 10 healthy hospital staff is in progress:

      Each participants will be their own control. All participants will be measured for their
      baseline characteristics and outcomes of interest on a regular working day as well as at the
      end of 2 nights of shift work. At the end of one shift they will be randomly assigned to
      receive a 30-minute-long "upper body massage", while at the end of the other shift they will
      receive a "reading intervention" which would serve as a control intervention. Randomization
      is done using a computer system that also verifies inclusion-exclusion criteria before
      allocating the intervention.

      The autonomic profile is measured by spectral analysis of Heart Rate Variability (HRV)
      captured by a state-of-the-art machine which non-invasively records electrical signals from
      the body. The inflammatory markers in the blood are also measured using top-notch laboratory
      technology.

      The results of the study will be reported by comparing the outcomes of each subject with
      their own baseline as well as comparing the two interventions for the effect of massage. Data
      will be pooled for all subjects in order to show the overall effect.

      The final results of this study will be used to plan stress management intervention trials.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Heart Rate Variability (HRV) parameters
time frame: up to 1 month
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.
The HRV parameters will be measured at 5 different time points all at approximately the same time in the morning. These 5 time points are as follows:
Baseline measurement: This measurement takes place on a regular working day with no night shift at the end of the day or the night before.
Shift measurements (Pre-intervention): These consist of measurements before interventions at the end of two separate nights of shift work.
Post-intervention measurements: These consist of measurements after interventions at the end of two separate nights of shift work.
measure: Pre-ejection period (PEP)
time frame: up to 1 month
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 will be measured at 5 different time points all at approximately the same time in the morning. These 5 time points are as follows:
Baseline measurement: This measurement takes place on a regular working day with no night shift at the end of the day or the night before.
Shift measurements (Pre-intervention): These consist of measurements before interventions at the end of two separate nights of shift work.
Post-intervention measurements: These consist of measurements after interventions at the end of two separate nights of shift work.
measure: Pro-inflammatory cytokines
time frame: 5 times within 1 month
description: These consist of protein and mRNA levels of secreted pro-inflammatory cytokines (IL-6, IL-1beta and TNF-alpha) in blood.
The pro-inflammatory cytokines will be measured at 5 different time points all at approximately the same time in the morning. These 5 time points are as follows:
Baseline measurement: This measurement takes place on a regular working day with no night shift at the end of the day or the night before.
Shift measurements (Pre-intervention): These consist of measurements before interventions at the end of two separate nights of shift work.
Post-intervention measurements: These consist of measurements after interventions at the end of two separate nights of shift work.
measure: Plasma Cortisol level
time frame: 5 times within 1 month
description: The plasma cortisol level will be measured at 5 different time points all at approximately the same time in the morning. These 5 time points are as follows:
Baseline measurement: This measurement takes place on a regular working day with no night shift at the end of the day or the night before.
Shift measurements (Pre-intervention): These consist of measurements before interventions at the end of two separate nights of shift work.
Post-intervention measurements: These consist of measurements after interventions at the end of two separate nights of shift work.
measure: Blood Pressure
time frame: 5 times within 1 month
description: Systolic and diastolic Blood pressure will be measure at 5 different time points all at approximately the same time in the morning. These 5 time points are as follows:
Baseline measurement: This measurement takes place on a regular working day with no night shift at the end of the day or the night before.
Shift measurements (Pre-intervention): These consist of measurements before interventions at the end of two separate nights of shift work.
Post-intervention measurements: These consist of measurements after interventions at the end of two separate nights of shift work.
measure: Heart Rate
time frame: 5 times within 1 month
description: Average of beat to beat heart rate (in beats per minute) will be measured at 5 different time points all at approximately the same time in the morning. These 5 time points are as follows:
Baseline measurement: This measurement takes place on a regular working day with no night shift at the end of the day or the night before.
Shift measurements (Pre-intervention): These consist of measurements before interventions at the end of two separate nights of shift work.
Post-intervention measurements: These consist of measurements after interventions at the end of two separate nights of shift work.
intervention type: Other
intervention name: Massage Therapy
description: Intervention consists of administering a 30-minute-long upper body massage by a registered massage therapist following a massage protocol developed by Vancouver College of Massage Therapy (VCMT).
intervention type: Other
intervention name: Journal reading (No massage therapy)
description: Intervention consists of journal reading in the same sitting position as the massage therapy session for approximately 30 minutes.
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
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, MD, PhD Candidate
role: Principal Investigator
affiliation: The University of British Columbia
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of British Columbia
investigator full name: Mir Sohail Fazeli
investigator title: Principle Investigator