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

NCT02215486 | Completed

• 1 other identifier: H13-03391
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

The Effect of Head Massage Therapy on the Autonomic Nervous System

Keywords

Head massage therapy; Massage therapy; Autonomic nervous system (ANS); Heart rate variability (HRV); Pre-ejection period (PEP)

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

Head Massage Therapy OTHER

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

Simple relaxation (No Head Massage) OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Otherwise healthy individuals

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's & Women's Health Centre of British Columbia: lead

Study Sites (1)

BC Children's and Women's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

Location

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: August 9, 2014
• First Posted: August 13, 2014
• Study Start: April 1, 2014
• Primary Completion: September 1, 2014
• Last Updated: May 28, 2015

Record last verified: 2015-05

Locations

CA (1)