Entrainment Between Clinician and Patient During Palpation

NCT03579238 | Completed

• 1 other identifier: 1209771-1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Doctor Patient Relation

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (4)

Distant

NO INTERVENTION

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

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

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.

Procedure: touching

Occipital motion inhibition

EXPERIMENTAL

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.

Procedure: CV4

Interventions

CV4 PROCEDURE

The occiput of a supine patient is held such that flexion motion is inhibited and extension motion is reinforced.

Also known as: Modified CV4, CV-4

Occipital motion inhibition

touching PROCEDURE

the clinician allows the participant's head to rest quietly upon his open palms on a table.

Also known as: light touch

touching

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Western University of Health Sciences: lead

Study Sites (1)

Western University of Health Sciences

Pomona, California, 91766, United States

Location

MeSH Terms

Interventions

Touch

Intervention Hierarchy (Ancestors)

Sensation; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Michael Seffinger, D.O.

  Western University of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The clinicians, participants, researchers and statistician will not know which stage of interaction (distant, close, touching, pulling) induces entrainment, if at all. Statistician will be blinded to stage allocation of each data set, and stages of interaction will be randomized per encounter.
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Intrasubject sequential intervention design

Study Record Dates

• First Submitted: June 25, 2018
• First Posted: July 6, 2018
• Study Start: June 25, 2018
• Primary Completion: July 15, 2018
• Study Completion: July 18, 2018
• Last Updated: October 3, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)