BC Children's and Women's Hospital
Vancouver, British Columbia, V6H 3N1, Canada
Completed
NCT Number: NCT02215486
The Effect of Head Massage Therapy on the Regulation of the Autonomic Nervous System
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.
Completed
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Notify MeKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Head Massage Therapy
OtherIntervention consists of administering head massage therapy according to the Chinese head massage protocol for approximately 10 minutes.
Simple relaxation (No Head Massage)
OtherConsists of a simple relaxation in the same sitting position as the head massage therapy session.
Primary outcomes
-
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.
Sponsors and collaborators
Lead sponsor
Children's & Women's Health Centre of British Columbia
Other
Registry information
Official study 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
Important dates
- Study start
- 2014
- Primary completion
- 2014
- First posted
- Aug 13, 2014
- Registry last updated
- May 28, 2015
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.