StressNCT02247089

The Effect of Massage Therapy to Control Night Shift Related Stress

A study testing Massage Therapy and Journal reading (No massage therapy) in people with Stress, run by University of British Columbia at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 20 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Stress
What is being tested?: Massage Therapy and Journal reading (No massage therapy)
How many people: 12 participants
Where: 1 siteCanada
Study dates: Feb 2014to Jun 2016
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

BC Children's and Women's Hospital
Vancouver, British Columbia, V6H 3N1

Other trials in Canada

About this study

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

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:

To assess the physiological effects of night shifts on the ANS profile and bio-markers of inflammation and stress in blood
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.

Conditions: Stress
Being tested: Massage Therapy, Journal reading (No massage therapy)
Keywords: Night Shift work, Stress, Autonomic nervous system (ANS), Heart rate variability (HRV), Pre-ejection period (PEP), Inflammation, Pro-inflammatory cytokines, Massage Therapy
Medical subject headings: Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Massage TherapyOther
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: up to 1 month

Secondary outcomes (2)

Pro-inflammatory cytokines
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.
Measured: 5 times within 1 month
Plasma Cortisol level
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.
Measured: 5 times within 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2014Jun 2016

First posted23 Sep 2014 (estimated)
Study startFeb 2014
Primary completionJun 2016
Study completionJun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for StressStudies of the same condition, open and under way.
More trials run by University of British ColumbiaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02247089
Sponsor's protocol ID: H13-01584
Status last verified: Oct 2017
First submitted: 10 Sep 2014
Last updated: 26 Oct 2017
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 32922577

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Massage Therapy to Control Night Shift Related Stress: A Pilot Prospective Randomized Crossover Trial
ClinicalTrials.gov ID: NCT02247089
Acronym / sponsor ID: H13-01584
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
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: University of British ColumbiaUniversity, hospital or other
Collaborators: Registered Massage Therapists Association of British Columbia
Study start: Feb 2014
Primary completion: Jun 2016 (actual)
Study completion: Jun 2016 (actual)
First posted: 23 Sep 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Background:

Objectives:

To assess the physiological effects of night shifts on the ANS profile and bio-markers of inflammation and stress in blood
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:

The final results of this study will be used to plan stress management intervention trials.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)

Who may qualify

Ages: 20 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Massage TherapyIntervention 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.	Other	–

Primary outcome

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.
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.

2 secondary outcomes

Pro-inflammatory cytokines
Time frame: 5 times within 1 month
Plasma Cortisol level
Time frame: 5 times within 1 month

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
Derived from this study: PubMed 32922577Fazeli 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jean-Paul Collet, MD, PhD principal investigator

Children's & Women's Health Centre of British Columbia

Mir Sohail Fazeli, MD, PhD Candidate principal investigator

The University of British Columbia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Massage Therapy and Journal reading (No massage therapy) in people with Stress, run by University of British Columbia at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Heart Rate Variability (HRV) parameters (time frame: up to 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02247089, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2017.