The Effect of Head Massage Therapy on the Autonomic Nervous System Clinical Trial
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
| NCT number | NCT02215486 |
| Other study ID # | H13-03391 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | August 9, 2014 |
| Last updated | May 26, 2015 |
| Start date | April 2014 |
| Verified date | May 2015 |
| Source | Children's & Women's Health Centre of British Columbia |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Canada: Health Canada |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 10 |
| Est. completion date | |
| Est. primary completion date | September 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| Canada | BC Children's and Women's Hospital | Vancouver | British Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| Children's & Women's Health Centre of British Columbia |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Primary | 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 | No |