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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03579238
Other study ID # 1209771-1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 25, 2018
Est. completion date July 18, 2018

Study information

Verified date October 2018
Source Western University of Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will assess the physiological interaction between the palpating clinician and a research participant using a laser Doppler flow meter to detect changes in blood flow parameters.


Description:

Research participants will lie on their backs on a soft table while a licensed physician, with special training in osteopathic palpation and manipulation approaches, touches, and administers a slight inhibition of occipital bone motion for five minutes per stage. Both will have a non invasive skin sensor (probe), called a laser Doppler flow meter, attached to their forehead to detect changes in subcutaneous blood flow velocity. The signal from the device will be augmented and transmitted for display onto a digital polygraph recorder. Then, using Fourier transformation software, the signal will be displayed as a graph for spectral analysis to determine the effect on specific wave forms related to autonomic activity. The interaction between the two individuals will be assessed for evidence of entrainment phenomenon, i.e., the influence of one biorhythm upon another.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date July 18, 2018
Est. primary completion date July 15, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- healthy adult that can lie on his or her back on a padded table without moving for 35 minutes.

Exclusion Criteria:

- head trauma within the last six months, seizure disorder, pregnant, brain disease or injury, using beta or alpha blocker medication, unable to lie still for 35 minutes, allergy to the hypoallergenic sticky tape used to attach sensor to forehead

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
CV4
The occiput of a supine patient is held such that flexion motion is inhibited and extension motion is reinforced.
touching
the clinician allows the participant's head to rest quietly upon his open palms on a table.

Locations

Country Name City State
United States Western University of Health Sciences Pomona California

Sponsors (1)

Lead Sponsor Collaborator
Western University of Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Entrainment of still points between clinician and research participant When one person has a still point it may or may not affect the other person. If it does, then entrainment will have occurred. The clinician's intent is to create a still point in the participant by inhibiting occipital motion. This is measurable using the laser Doppler flow meter. The induction of the still point, which is manifest on the polygraph and in spectroscopy as a distinct diminished amplitude at the .08-1.5 Hz frequency, may entrain the clinician to have a still point as well. within 1 minute of each other (arbitrary designation)
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