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The Effect of Massage Therapy to Control Night Shift Related Stress

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02247089
Enrollment
12
Registered
2014-09-23
Start date
2014-02-28
Completion date
2016-06-30
Last updated
2017-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

OTHERMassage 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).

OTHERJournal reading (No massage therapy)

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

Sponsors

Registered Massage Therapists Association of British Columbia
CollaboratorOTHER
University of British Columbia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Heart Rate Variability (HRV) parametersup to 1 monthMain 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.
Pre-ejection period (PEP)up to 1 monthPEP 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

MeasureTime frameDescription
Pro-inflammatory cytokines5 times within 1 monthThese 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.
Plasma Cortisol level5 times within 1 monthThe 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

MeasureTime frameDescription
Blood Pressure5 times within 1 monthSystolic 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.
Heart Rate5 times within 1 monthAverage 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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026