Clinical trial NCT02247089: The Effect of Massage Therapy to Control Night Shift Related Stress
Official title: The Effect of Massage Therapy to Control Night Shift Related Stress: A Pilot Prospective Randomized Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Keywords: Night Shift work
Stress
Autonomic nervous system (ANS)
Heart rate variability (HRV)
Pre-ejection period (PEP)
Inflammation
Pro-inflammatory cytokines
Massage Therapy
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Registered Massage Therapists Association of British Columbia
First posted: 2014-09-23
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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.

Primary outcomes:
measure: Heart Rate Variability (HRV) parameters
timeFrame: up to 1 month
measure: Pre-ejection period (PEP)
timeFrame: up to 1 month
Secondary outcomes:
measure: Pro-inflammatory cytokines
timeFrame: 5 times within 1 month
measure: Plasma Cortisol level
timeFrame: 5 times within 1 month
Other outcomes:
measure: Blood Pressure
timeFrame: 5 times within 1 month
measure: Heart Rate
timeFrame: 5 times within 1 month
Locations:
city: Vancouver
country: Canada
facility: BC Children's and Women's Hospital
state: British Columbia
Study officials:
affiliation: Children's & Women's Health Centre of British Columbia
name: Jean-Paul Collet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of British Columbia
name: Mir Sohail Fazeli, MD, PhD Candidate
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fazeli MS, Pourrahmat MM, Massah G, Lee K, Lavoie PM, Fazeli M, Esser A, Collet JP. The Effect of Massage on the Cardiac Autonomic Nervous System and Markers of Inflammation in Night Shift Workers: a Pilot Randomized Crossover Trial. Int J Ther Massage Bodywork. 2020 Aug 27;13(3):6-17. eCollection 2020 Sep.