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

Study Overview
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Brief Summary
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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.

Official Title
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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

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

Intervention / Treatment
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* Other: Head Massage Therapy
* Other: Simple relaxation (No Head Massage)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. 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 | Within 1 day | 
| 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 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. | Within 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Head massage therapy, Massage therapy, Autonomic nervous system (ANS), Heart rate variability (HRV), Pre-ejection period (PEP)