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

NCT ID: NCT02215486

Last Updated: 2015-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

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.

Detailed Description

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Conditions

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The Effect of Head Massage Therapy on the Autonomic Nervous System

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Interventions

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Head Massage Therapy

Intervention consists of administering head massage therapy according to the Chinese head massage protocol for approximately 10 minutes.

Intervention Type OTHER

Simple relaxation (No Head Massage)

Consists of a simple relaxation in the same sitting position as the head massage therapy session.

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Jean-Paul Collet

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jean-Paul Collet, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Mir Sohail Fazeli, M.D.

Role: PRINCIPAL_INVESTIGATOR

The University of British Columbia

Locations

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BC Children's and Women's Hospital

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

Other Identifiers

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H13-03391

Identifier Type: -

Identifier Source: org_study_id

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