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

Sponsor

Children's & Women's Health Centre of British Columbia (Other)

Overall Status

Completed

CT.gov ID

NCT02215486

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

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)	N/A

Study Design

Study Type:

Interventional

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 :

Apr 1, 2014

Actual Primary Completion Date :

Sep 1, 2014

Outcome Measures

Primary Outcome Measures

Heart Rate Variability (HRV) parameters [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
Pre-ejection period (PEP) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

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