UMIN-CTR Clinical Trial

Public title

Examination of effectiveness of an intervention program to enhance "self-confidence in answering questions when asked" for professionals who consult health concerns

Acronym

Examination of effectiveness of an intervention program to enhance "self-confidence in answering questions when asked" for professionals who consult health concerns

Scientific Title

Examination of effectiveness of an intervention program to enhance self-confidence in dealing with radiation-related health concerns of nursery teachers

Scientific Title:Acronym

Examination of effectiveness of an intervention program to enhance self-confidence in dealing with radiation-related health concerns of nursery teachers

Region

Japan

Condition

Healthy Adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To examine effectiveness of a "literacy enhancement program" targeting professionals that frequently receive consultations about radiation health concerns from parents of young children

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Self-confidence (Acute effect of the program)

Key secondary outcomes

Radiation-related knowledge
Literacy

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

Lecture 50minutes
Group Discussion 40minutes
Presentation 10minutes

Interventions/Control_2

Provision of materials

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

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

N/A

Key exclusion criteria

N/A

Target sample size

50

Name of lead principal investigator

1st name	Seiji
Middle name
Last name	Yasumura

Organization

Fukushima Medical University School of Medicine

Division name

Department of Public Health

Zip code

960-1295

Address

1, Hikarigaoka, Fukushima

TEL

+81245471180

Email

yasumura@fmu.ac.jp

Name of contact person

1st name	Seiji
Middle name
Last name	Yasumura

Organization

Fukushima Medical University School of Medicine

Division name

Department of Public Health

Zip code

960-1295

Address

1, Hikarigaoka, Fukushima

TEL

+81245471180

Homepage URL

Email

yasumura@fmu.ac.jp

Institute

Fukushima Medical University

Institute

Department

Personal name

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Fukushima Medical University

Address

1, Hikarigaoka, Fukushima

Tel

0245471825

Email

rs@fmu.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

Date of disclosure of the study information

2021

Year

09

Month

19

Day

URL releasing protocol

N/A

Publication of results

Unpublished

URL related to results and publications

N/A

Number of participants that the trial has enrolled

26

Results

Improvements in self-confidence were greater in the intervention group than in the control group, in which individuals only received the written materials used in the intervention program, suggesting that this program effectively enhanced their self-confidence.
Literacy and knowledge regarding radiation also improved among the participants of this program, which can enhance their self-confidence.

Results date posted

2023

Year

02

Month

11

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Kindergarten teachers working in two private kindergartens in Fukushima

Participant flow

Twenty-seven workers employed at the selected kindergartens agreed to participate in the study. Participants were informed that the intervention program would be held on two separate days and that they could choose either at their convenience. Those who chose the earlier day were categorized into the intervention group, and the remaining participants formed the control group. Ten participating kindergarten teachers were assigned to the intervention group, and 17 were assigned to the control group. One control group participant who did not participate in the program was excluded from the analysis. Thus, data from 10 and 16 participants in the intervention and control groups, respectively, were analyzed.

Adverse events

None

Outcome measures

Primary outcome:Self-confidence in response to questions on radiation health effects
Secondary outcomes: Knowledge of the health effects of radiation, health literacy

Plan to share IPD

IPD sharing Plan description

Recruitment status

No longer recruiting

Date of protocol fixation

2021

Year

08

Month

23

Day

Date of IRB

2021

Year

08

Month

23

Day

Anticipated trial start date

2021

Year

09

Month

21

Day

Last follow-up date

2021

Year

11

Month

14

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2021

Year

09

Month

19

Day

Last modified on

2023

Year

02

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051967