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The Effect of Massage Therapy to Control Night Shift Related Stress

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ClinicalTrials.gov Identifier: NCT02247089
Recruitment Status : Completed
First Posted : September 23, 2014
Last Update Posted : October 26, 2017
Sponsor:
Collaborator:
Registered Massage Therapists Association of British Columbia
Information provided by (Responsible Party):
Mir Sohail Fazeli, University of British Columbia

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Stress Other: Massage Therapy Other: Journal reading (No massage therapy) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effect of Massage Therapy to Control Night Shift Related Stress: A Pilot Prospective Randomized Crossover Trial
Study Start Date : February 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Intervention Details:
  • Other: Massage Therapy
    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).
  • Other: Journal reading (No massage therapy)
    Intervention consists of journal reading in the same sitting position as the massage therapy session for approximately 30 minutes.


Primary Outcome Measures :
  1. Heart Rate Variability (HRV) parameters [ Time Frame: up to 1 month ]

    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:

    1. 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.
    2. Shift measurements (Pre-intervention): These consist of measurements before interventions at the end of two separate nights of shift work.
    3. Post-intervention measurements: These consist of measurements after interventions at the end of two separate nights of shift work.

  2. Pre-ejection period (PEP) [ Time Frame: up to 1 month ]

    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:

    1. 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.
    2. Shift measurements (Pre-intervention): These consist of measurements before interventions at the end of two separate nights of shift work.
    3. Post-intervention measurements: These consist of measurements after interventions at the end of two separate nights of shift work.


Secondary Outcome Measures :
  1. Pro-inflammatory cytokines [ Time Frame: 5 times within 1 month ]

    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:

    1. 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.
    2. Shift measurements (Pre-intervention): These consist of measurements before interventions at the end of two separate nights of shift work.
    3. Post-intervention measurements: These consist of measurements after interventions at the end of two separate nights of shift work.

  2. Plasma Cortisol level [ Time Frame: 5 times within 1 month ]

    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:

    1. 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.
    2. Shift measurements (Pre-intervention): These consist of measurements before interventions at the end of two separate nights of shift work.
    3. Post-intervention measurements: These consist of measurements after interventions at the end of two separate nights of shift work.


Other Outcome Measures:
  1. Blood Pressure [ Time Frame: 5 times within 1 month ]

    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:

    1. 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.
    2. Shift measurements (Pre-intervention): These consist of measurements before interventions at the end of two separate nights of shift work.
    3. Post-intervention measurements: These consist of measurements after interventions at the end of two separate nights of shift work.

  2. Heart Rate [ Time Frame: 5 times within 1 month ]

    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:

    1. 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.
    2. Shift measurements (Pre-intervention): These consist of measurements before interventions at the end of two separate nights of shift work.
    3. Post-intervention measurements: These consist of measurements after interventions at the end of two separate nights of shift work.



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Otherwise healthy hospital staff between the ages of 20 to 60 taking rotating night shifts on a regular basis.

Exclusion Criteria:

  • Participants who are on anti-depressants or drugs that affect the cardiovascular system or the ANS.
  • Any conditions or disorders that would affect the cardiovascular system or the activity of the ANS.
  • Participants who smoke more than 10 cigarettes/day.
  • Inability to provide consent.
  • Inability to speak and/or understand English.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02247089


Locations
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Canada, British Columbia
BC Children's and Women's Hospital
Vancouver, British Columbia, Canada, V6H 3N1
Sponsors and Collaborators
University of British Columbia
Registered Massage Therapists Association of British Columbia
Investigators
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Principal Investigator: Jean-Paul Collet, MD, PhD Children's & Women's Health Centre of British Columbia
Principal Investigator: Mir Sohail Fazeli, MD, PhD Candidate The University of British Columbia

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Responsible Party: Mir Sohail Fazeli, Principle Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT02247089     History of Changes
Other Study ID Numbers: H13-01584
First Posted: September 23, 2014    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Keywords provided by Mir Sohail Fazeli, University of British Columbia:
Night Shift work
Stress
Autonomic nervous system (ANS)
Heart rate variability (HRV)
Pre-ejection period (PEP)
Inflammation
Pro-inflammatory cytokines
Massage Therapy