UMIN-CTR Clinical Trial

Public title

Educational Effect of M-Test on the Clinical Ability of Pre- and post graduation Acupuncturist Training School Students

Acronym

Educational Effect of M-Test on the Acupuncture Clinical Ability

Scientific Title

Educational Effect of M-Test on the Clinical Ability of Pre- and post graduation Acupuncturist Training School Students

Scientific Title:Acronym

Educational Effect of M-Test on the Acupuncture Clinical Ability

Region

Japan

Condition

Pre- and post graduation Acupuncturist Training School Students

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Communication between healthcare professionals and patients has attracted attention since 1980s, and it is regarded today as the fourth leading healthcare technology next only to pharmaceuticals, treatment, and surgery. For communication between acupuncturists and patients, only a limited finding from our cross-sectional investigation is available, and a longitudinal effect via clinical education has not been examined. In addition, a method to quantitatively evaluate the clinical competency of acupuncturists (including the ability to communicate with patients) has not been established thus far. Therefore, we aimed to examine the education effect after quantitatively evaluating the clinical competency of pre-graduate students who were enrolled at acupuncturist training facilities.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Clinical competency index was measured in terms of [1] patient satisfaction level, [2] health improvement level, [3] degree of reliability of the practitioner, and [4] reasonable therapy cost, before/after taking a 300-min course on "clinical education about acupuncture treatment"

Key secondary outcomes

Self-evaluation as a practitioner and objective evaluation by simulated patients regarding the following items and their differences: [1] personal characteristics of the pre-graduate student (i) course performance rated by GPA, (ii) satisfaction level with clinical education about acupuncture therapy, (iii) self-evaluation of communication skill with the patient, (iv) self-evaluation of comprehensive clinical competency of acupuncture therapy, and (v) future prospects as an acupuncturist; [2] communication pattern evaluated before/after taking the 300-min course on "clinical education about acupuncture treatment" (i) responded politely, (ii) created a comfortable atmosphere for the patient to communicate, (iii) listened to the patient's complaint, (iv) fully understood the patient's complaint, (v) sufficiently explained about the patient's condition, and (vi) offered an easy-to-understand explanation; and [3] acupuncture therapy pattern (i) evaluation of treatment technique, (ii) time required for clinical examinations and tests, (iii) time required for treatment, (iv) the number of acupuncture points in which needles were inserted (including contact needling), (v) average acupuncture depth, and (vi) the maximum acupuncture depth.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

Intervention: Persons able to attend the 300-min course on "clinical education about acupuncture treatment (same contents as the M-Test seminar for beginners)"

Interventions/Control_2

Control: Non-intervention

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

[1] Pre-graduate students enrolled in the "acupuncturist" training course at the institution of the trial site who gave written consent to participate in this study
[2] Acupuncturist
[3] Students available to commute to the study site during the study period

Key exclusion criteria

[1] Students who already took the M-Test seminar for beginners
[2] Pregnant women, persons who are in an acute state or require surgery, persons with malignant tumors, or persons with hemorrhagic disease

Target sample size

150

Name of lead principal investigator

1st name	Shogo
Middle name
Last name	Miyazaki

Organization

Teikyo Heisei University

Division name

Department of Acupuncture and Moxibustion, Faculty of Health Care

Zip code

1708445

Address

2-51-4 Higashiikebukuro, Toshima-ku, Tokyo, Japan

TEL

+81-3-5843-3111

Email

s.miyazaki@thu.ac.jp

Name of contact person

1st name	Shogo
Middle name
Last name	Miyazaki

Organization

Teikyo Heisei University

Division name

Department of Acupuncture and Moxibustion, Faculty of Health Care

Zip code

1708445

Address

2-51-4 Higashiikebukuro, Toshima-ku, Tokyo, Japan

TEL

+81-3-5843-3111

Homepage URL

Email

s.miyazaki@thu.ac.jp

Institute

Teikyo Heisei University

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Teikyo Heisei University Ethical Committee

Address

2-51-4 Higashiikebukuro, Toshima-ku, Tokyo, Japan

Tel

+81-3-5843-3111

Email

rec@thu.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

帝京平成大学（東京都）/Teikyo Heisei University (Tokyo)

Date of disclosure of the study information

2015

Year

09

Month

07

Day

URL releasing protocol

https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000021778

Publication of results

Partially published

URL related to results and publications

https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000021778

Number of participants that the trial has enrolled

12

Results

Clinical education increased the proportion of patients who rate positively in 10 of 11 items, increasing from 31% to 58% on average for 11 items.
In particular, "therapist's response", "health improvement", and "willingness to pay" exceeded the results of acupuncturists.
Therefore, it was suggested that acquisition of M-Test (Meridian-Test) was effective as education for the above items.

Results date posted

2020

Year

03

Month

11

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

[1] Pre-graduate students enrolled in the "acupuncturist" training course at the institution of the trial site who gave written consent to participate in this study.

Participant flow

N=12

Adverse events

none.

Outcome measures

Clinical competency index was measured in terms of [1] patient satisfaction level, [2] health improvement level, [3] degree of reliability of the practitioner, and [4] reasonable therapy cost, before/after taking a 300-min course on "clinical education about acupuncture treatment"

Plan to share IPD

IPD sharing Plan description

Recruitment status

No longer recruiting

Date of protocol fixation

2015

Year

09

Month

03

Day

Date of IRB

2015

Year

09

Month

03

Day

Anticipated trial start date

2015

Year

09

Month

07

Day

Last follow-up date

2018

Year

03

Month

31

Day

Date of closure to data entry

2018

Year

03

Month

31

Day

Date trial data considered complete

2018

Year

03

Month

31

Day

Date analysis concluded

Other related information

Registered date

2015

Year

09

Month

07

Day

Last modified on

2020

Year

03

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021778