Doctor Patient RelationNCT03579238
Entrainment Between Clinician and Patient During Palpation
A study testing CV4 and touching in people with Doctor Patient Relation, run by Western University of Health Sciences at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Doctor Patient Relation
- What is being tested?
- CV4 and touching
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2018to 18 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy adult that can lie on his or her back on a padded table without moving for 35 minutes.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Western University of Health Sciences
Pomona, California, 91766
About this study
Official title: Entrainment Interaction Between Physician and Patient During Palpation of the Cranium
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.
Read the detailed 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.
- Conditions
- Doctor Patient Relation
- Being tested
- CV4, touching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CV4Procedure or surgery
Also called Modified CV4, CV-4
The occiput of a supine patient is held such that flexion motion is inhibited and extension motion is reinforced.
touchingProcedure or surgery
Also called light touch
the clinician allows the participant's head to rest quietly upon his open palms on a table.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: CV4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 1 minute of each other (arbitrary designation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start25 Jun 2018
- Primary completion15 Jul 2018
- Study completion18 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Doctor Patient RelationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Intrasubject sequential intervention design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Seffinger, Western University of Health Sciences
- Investigators
- Michael Seffinger, D.O., Principal investigator, Western University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03579238
- Sponsor's protocol ID
- 1209771-1
- Status last verified
- Oct 2018
- First submitted
- 25 Jun 2018
- Last updated
- 3 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The overall results of the study and examples of entrainment phenomenon can be extracted from the data gathered for sharing and informational purposes.
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Entrainment Interaction Between Physician and Patient During Palpation of the Cranium
- ClinicalTrials.gov ID
- NCT03579238
- Acronym / sponsor ID
- 1209771-1
- Conditions
- Doctor Patient Relation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Western University of Health SciencesUniversity, hospital or other
- Study start
- 25 Jun 2018 (actual)
- Primary completion
- 15 Jul 2018 (actual)
- Study completion
- 18 Jul 2018 (actual)
- First posted
- 6 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Intrasubject sequential intervention design
| Arm | Type | Receives |
|---|---|---|
| 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 | Procedure: touchingThe 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. |
| Occipital motion inhibition | Experimental | Procedure: CV4The 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy adult that can lie on his or her back on a padded table without moving for 35 minutes.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CV4Also: Modified CV4, CV-4The occiput of a supine patient is held such that flexion motion is inhibited and extension motion is reinforced. | Procedure or surgery | Occipital motion inhibition |
| touchingAlso: light touchthe clinician allows the participant's head to rest quietly upon his open palms on a table. | Procedure or surgery | touching |
Primary outcome
Entrainment of still points between clinician and research participant
Time frame: within 1 minute of each other (arbitrary designation)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2018.
- Individual participant dataSharing planned: No. The overall results of the study and examples of entrainment phenomenon can be extracted from the data gathered for sharing and informational purposes.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Seffinger, D.O. principal investigator
Western University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CV4 and touching in people with Doctor Patient Relation, run by Western University of Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Entrainment of still points between clinician and research participant (time frame: within 1 minute of each other (arbitrary designation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2018.