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

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

Tracking Information

• First Submitted Date: August 9, 2014
• First Posted Date: August 13, 2014
• Last Update Posted Date: May 28, 2015
• Study Start Date: April 2014
• Actual Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 11, 2014)

• 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
• 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.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Effect of Head Massage Therapy on the Regulation of the Autonomic Nervous System
• 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

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Condition: The Effect of Head Massage Therapy on the Autonomic Nervous System

Intervention

• 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.

• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 11, 2014): 10
• Original Estimated Enrollment: Same as current
• Study Completion Date: Not Provided
• Actual Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT02215486
• Other Study ID Numbers: H13-03391
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Jean-Paul Collet, Children's & Women's Health Centre of British Columbia
• Study Sponsor: Children's & Women's Health Centre of British Columbia
• Collaborators: Not Provided

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

• PRS Account: Children's & Women's Health Centre of British Columbia
• Verification Date: May 2015