Entrainment Between Clinician and Patient During Palpation

Western University of Health Sciences (WESTERN U)

Status: Completed

Conditions: Doctor Patient Relation

Treatments: Procedure: CV4; Procedure: touching

Study type: Interventional

Funder types: Other

Identifiers

NCT03579238

1209771-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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20 participants in 4 patient groups

Distant

No Intervention group

Description:

The clinician sits quietly 3 feet away from participant who is lying on a soft table at rest.This position is held for 5 minutes without moving.

close

No Intervention group

Description:

The clinician sits at the head of the table with his arms on the table alongside the participant's head but not touching the resting patient who is lying at rest on the table. This position is held for 5 minutes without moving.

touching

Sham Comparator group

Description:

The clinician lifts the patient's head passively off the table in order to place his hands underneath the participant's head, palms facing upwards and in contact with the back of the head of the participant. The participant's head is gently lowered to rest upon the clinician's hands. No external force is provided by the clinician upon the participant's head as the head rests in the clinician's palms on the table. This position is held for 5 minutes without moving. This is called a "touching" intervention and is meant to be a sham. A five minute rest period follows in which the clinician removes his hands from underneath the participant's head and places them next to the patient on the table, but not in contact with the patient.

Treatment:

Procedure: touching

Occipital motion inhibition

Experimental group

Description:

The clinician gently inhibits motion of the participant's occiput into flexion phase of the primary respiratory mechanism, and allows extension phase only. Upon sensing a still point, where no further flexion motion is palpated, the clinician will state to the research assistant "now" to indicate he feels a still point. This position is held for 5 minutes without moving. This is called a CV4 or modified CV4 intervention. A five minute rest period follows in which the clinician removes his hands from underneath the participant's head and places them next to the patient on the table, but not in contact with the patient.

Treatment:

Procedure: CV4