The Effect of Massage Therapy to Control Night Shift Related Stress

NCT02247089 | Completed

• 1 other identifier: H13-01584
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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. 1.To assess the physiological effects of night shifts on the ANS profile and bio-markers of inflammation and stress in blood
2. 2.To assess whether one session of massage therapy can revert the adverse effects of night shift via re-balancing these components.

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

Outcome Measures

Primary Outcomes (2)

• Heart Rate Variability (HRV) parameters

  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.

  up to 1 month

• Pre-ejection period (PEP)

  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.

  up to 1 month

Secondary Outcomes (2)

• Pro-inflammatory cytokines

  5 times within 1 month

• Plasma Cortisol level

  5 times within 1 month

Other Outcomes (2)

• Blood Pressure

  5 times within 1 month

• Heart Rate

  5 times within 1 month

Interventions

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.

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead
• Registered Massage Therapists Association of British Columbia: collaborator

Study Sites (1)

BC Children's and Women's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

Location

Related Publications (1)

• 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.

  PMID: 32922577 DERIVED

MeSH Terms

Conditions

Inflammation

Interventions

Massage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: September 10, 2014
• First Posted: September 23, 2014
• Study Start: February 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: October 26, 2017

Record last verified: 2017-10

Locations

CA (1)