UMIN-CTR Clinical Trial

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000018925
Receipt No. R000021778
Scientific Title Educational Effect of M-Test on the Clinical Ability of Pre- and post graduation Acupuncturist Training School Students
Date of disclosure of the study information 2015/09/07
Last modified on 2020/03/11 (Ver. 10)

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Basic information
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
Condition Pre- and post graduation Acupuncturist Training School Students
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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.

Base
Study type Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Teikyo Heisei University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
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
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

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

Other administrative information
Date of disclosure of the study information
2015 Year 09 Month 07 Day

Related information
URL releasing protocol https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000021778
Publication of results Partially published

Result
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

Progress
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
Other related information

Management information
Registered date
2015 Year 09 Month 07 Day
Last modified on
2020 Year 03 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021778