Unique ID issued by UMIN | UMIN000012575 |
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Receipt number | R000014708 |
Scientific Title | A Randomized Control Study to Investigate the Effectiveness of Childhood Immunization Education Program for Parents in the Perinatal Period |
Date of disclosure of the study information | 2013/12/18 |
Last modified on | 2019/07/07 11:34:44 |
A Randomized Control Study to Investigate the Effectiveness of Childhood Immunization Education Program for Parents in the Perinatal Period
Investigation of the Effectiveness of Childhood Immunization Education Program for Parents
A Randomized Control Study to Investigate the Effectiveness of Childhood Immunization Education Program for Parents in the Perinatal Period
Investigation of the Effectiveness of Childhood Immunization Education Program for Parents
Japan |
women during perinatal period
Obstetrics and Gynecology | Pediatrics | Nursing |
Adult |
Others
NO
The purpose of this study is to evaluate the efficacy of the education program for parents on childhood immunization devised to fit the situation of Japan where voluntary vaccines exist.
Efficacy
Confirmatory
Pragmatic
Not applicable
An immunization up-to-date status when the infant is at three months of age for HBV vaccine
An immunization up-to-date status when the infant is at three months of age for Rotavirus vaccine, Hib vaccine, and PCV13
Parental discussion about vaccinations
Looking for the primary physician for receiving vaccinations
A change in maternal intention to receive immunization, knowledge, attitudes and beliefs, and health literacy between the pre-study evaluation and post-study evaluation
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Central registration
2
Educational,Counseling,Training
Behavior,custom |
Intervention
In addition to the usual perinatal checkups and health education, the participants in an intervention group receive both (1) and (2). If possible, participant's husband (partner) or family would also be present in the sessions.
(1) During late pregnancy, pregnant women who visit prenatal check-up receive individual immunization education for 10 min.
(2) At one-month postpartum checkup, postpartum women are supposed to check whether being prepared to receive immunization for 3-5 min.
Control
The participants in a control group receive the usual perinatal checkups and health education.
18 | years-old | <= |
Not applicable |
Female
Correspond to all of the following in recruitment of participants at 29-33 weeks of gestation
(1) Pregnant women 18 years or older
(2) Pregnant women have a good command of written and spoken Japanese.
(3) Pregnant women can receive two interventions (late pregnancy and one month after the delivery).
Correspond to any of the following
(1) It is predicted that birth weight is estimated at less than 2000g due to intrauterine growth restriction (IUGR), or others.
(2) It is predicted that there is need for newborn hospitalization for more than one month.
(3) Those who are judged not capable of participating in the study by the obstetrician or midwife and nurse
175
1st name | Kiyoko |
Middle name | |
Last name | Kamibeppu |
Graduate School of Medicine, The University of Tokyo
Department of Family Nursing, Division of Health Sciences & Nursing
1130033
7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, JAPAN
03-5841-3556
kkamibeppu-tky@umin.ac.jp
1st name | Hiroko |
Middle name | |
Last name | Otsuka-Ono |
Graduate School of Medicine, The University of Tokyo
Department of Family Nursing, Division of Health Sciences & Nursing
1130033
7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, JAPAN
03-5841-3399
hirokoo-tky@umin.ac.jp
Graduate School of Medicine, The University of Tokyo
Pfizer Health Research Foundation
Non profit foundation
Japan
The Institutional Ethics Review Board of the University of Tokyo
7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, JAPAN
03-5841-0818
ethics@m.u-tokyo.ac.jp
NO
2013 | Year | 12 | Month | 18 | Day |
Unpublished
Completed
2013 | Year | 11 | Month | 28 | Day |
2013 | Year | 12 | Month | 16 | Day |
2013 | Year | 12 | Month | 18 | Day |
2014 | Year | 09 | Month | 03 | Day |
2014 | Year | 09 | Month | 03 | Day |
2014 | Year | 09 | Month | 03 | Day |
2015 | Year | 01 | Month | 28 | Day |
2013 | Year | 12 | Month | 14 | Day |
2019 | Year | 07 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014708
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