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Completed

NCT Number: NCT02247089

The Effect of Massage Therapy to Control Night Shift Related Stress

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.

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Key information

Conditions

Stress Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BC Children's and Women's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Massage therapy

Other

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).

Journal reading (No massage therapy)

Other

Intervention consists of journal reading in the same sitting position as the massage therapy session for approximately 30 minutes.

Primary outcomes

  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:

    • 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.

  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:

    • 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.

Secondary outcomes

  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:

    • 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.

  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:

    • 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.

Other outcomes

  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:

    • 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.

  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:

    • 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.

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Registered Massage Therapists Association of British Columbia

Registry information

Official study title

The Effect of Massage Therapy to Control Night Shift Related Stress: A Pilot Prospective Randomized Crossover Trial

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 23, 2014
Registry last updated
Oct 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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