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The Effect of Head Massage Therapy on the Regulation of the Autonomic Nervous System

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ClinicalTrials.gov Identifier: NCT02215486
Recruitment Status : Completed
First Posted : August 13, 2014
Last Update Posted : May 28, 2015
Sponsor:
Information provided by (Responsible Party):
Jean-Paul Collet, Children's & Women's Health Centre of British Columbia

Brief Summary:

The autonomic nervous system (ANS) unconsciously regulates the activities of vital organ systems such as the respiratory, circulatory, and urinary systems. It consists of two major components, the parasympathetic nervous system (PNS) and the sympathetic nervous system (SNS), which together are in charge of keeping our body in homeostasis. Homeostasis is the state of chemical and metabolic balance within an organism; it is disturbed in situations of uncontrolled stress.

Massage has been shown to decrease SNS and stimulate PNS; but most studies focused on full body massage, with limited assessment of ANS function, and lacked control groups.

The effects of head massage therapy (HMT) on regulating the activity of the ANS have not been studied before. In this pilot study, we propose that by randomizing 10 participants to sessions of HMT and 'Simple Relaxation' (no HMT), and by using a non-invasive method of measuring the ANS activity (spectral analysis of Heart Rate Variability [HRV] as well as Pre-ejection Period (PEP)), we will be able to investigate the effects of 10 minutes of HMT in comparison with the period of no HMT administered. We expect HMT to reduce stress, with a better and balanced profile of autonomic nervous system after receiving massage.


Condition or disease Intervention/treatment Phase
The Effect of Head Massage Therapy on the Autonomic Nervous System Other: Head Massage Therapy Other: Simple relaxation (No Head Massage) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Head Massage Intervention to Decrease Physiological Signs of Stress as Assessed by Changes in the Autonomic Nervous System Functions in Healthy Volunteers: A Pilot Study
Study Start Date : April 2014
Actual Primary Completion Date : September 2014

Intervention Details:
  • Other: Head Massage Therapy
    Intervention consists of administering head massage therapy according to the Chinese head massage protocol for approximately 10 minutes.
  • Other: Simple relaxation (No Head Massage)
    Consists of a simple relaxation in the same sitting position as the head massage therapy session.


Primary Outcome Measures :
  1. Heart Rate Variability (HRV) parameters [ Time Frame: Within 1 day ]

    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.

    HRV parameters are measured at baseline and post intervention. Post-intervention outcomes for each subject will be compared with their baseline. There will also be comparison of the outcomes between the massage and the control intervention, for the effect of massage therapy


  2. Pre-ejection period (PEP) [ Time Frame: Within 1 day ]

    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 is measured at baseline and post intervention. Post-intervention outcomes for each subject will be compared with their baseline. There will also be comparison of the outcomes between the massage and the control intervention, for the effect of massage therapy.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Otherwise healthy individuals

Exclusion Criteria:

  • Use of anti-depressants or drugs that affect the cardiovascular system or ANS
  • Smoking more than 10 cigarettes/day
  • Inability to provide consent
  • Inability to speak and/or understand English

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02215486


Locations
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Canada, British Columbia
BC Children's and Women's Hospital
Vancouver, British Columbia, Canada, V6H 3N1
Sponsors and Collaborators
Children's & Women's Health Centre of British Columbia
Investigators
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Principal Investigator: Jean-Paul Collet, MD, PhD Children's & Women's Health Centre of British Columbia
Principal Investigator: Mir Sohail Fazeli, M.D. The University of British Columbia

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Responsible Party: Jean-Paul Collet, Director, Children's & Women's Health Centre of British Columbia
ClinicalTrials.gov Identifier: NCT02215486    
Other Study ID Numbers: H13-03391
First Posted: August 13, 2014    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015
Keywords provided by Jean-Paul Collet, Children's & Women's Health Centre of British Columbia:
Head massage therapy
Massage therapy
Autonomic nervous system (ANS)
Heart rate variability (HRV)
Pre-ejection period (PEP)