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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 June 2015 |
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Main ID: |
NCT02215486 |
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Date of registration:
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09/08/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Effect of Head Massage Therapy on the Regulation of the Autonomic Nervous System
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Scientific title:
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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 |
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Date of first enrolment:
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April 2014 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02215486 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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Phase:
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N/A
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Countries of recruitment
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Canada
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Contacts
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Name:
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Mir Sohail Fazeli, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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The University of British Columbia |
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Name:
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Jean-Paul Collet, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Children's & Women's Health Centre of British Columbia |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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The Effect of Head Massage Therapy on the Autonomic Nervous System
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Intervention(s)
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Other: Head Massage Therapy
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Other: Simple relaxation (No Head Massage)
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Primary Outcome(s)
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Heart Rate Variability (HRV) parameters
[Time Frame: Within 1 day]
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Pre-ejection period (PEP)
[Time Frame: Within 1 day]
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Secondary ID(s)
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H13-03391
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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