UMIN-ICDS Clinical Trial

Public title

A randomized trial comparing a serious game with video materials for learning before and after parenting classes

Acronym

Serious game for parenting class study

Scientific Title

Effect of perinatal education using a serious game in parenting classes: a parallel-group randomized controlled trial versus video materials

Scientific Title:Acronym

Parenting class serious game RCT

Region

Japan

Condition

Pregnancy (primiparous women attending parenting classes and their partners)

Classification by specialty

Obstetrics and Gynecology	Nursing	Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To determine whether a serious game, used as learning material before and after parenting classes, improves knowledge acquisition and learning engagement (completion rate and learning time) compared with the video materials currently in use.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Score on Knowledge Test 1 (pregnancy and antenatal care; 10 three-option multiple-choice items; range 0 to 10) at the start of the parenting class (T1) among primiparous women. Groups are compared by analysis of covariance adjusted for the baseline (T0) score, age, gestational age at the class, and class session.

Key secondary outcomes

1. Score on Knowledge Test 2 (childbirth and infant care; 10 three-option items) at 14 days or more after the class and before delivery (T2)
2. Completion rate of the assigned materials (90% or more of the content reached)
3. Actual time spent on the materials (game play time / video viewing time)
4. Change in score from baseline (T0) to T1, limited to the 5 items administered at T0
5. Fear of childbirth score (two 0-to-10 items) at T2, adjusted for T0
6. Partners' knowledge test scores at T1 and T2
7. Ratings of the materials (satisfaction, willingness to recommend, intention to continue) at T2

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

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

Behavior,custom

Interventions/Control_1

Serious game group: Participants use a browser-based serious game at home on their own smartphone or tablet. The pregnancy part (9 chapters, about 60 minutes) is used before the parenting class, and the childbirth and infant care part (5 chapters, about 40 to 60 minutes) within 2 weeks after the class. The parenting class itself is attended as usual. Allocation is by couple; a participating partner is assigned to the same group as the pregnant woman.

Interventions/Control_2

Video group (control): Participants watch the video materials currently used for pre-class learning at home. Course 1 (pregnancy and preparation, about 49 minutes) is watched before the parenting class, and Courses 2 and 3 (childbirth and infant care, about 59 minutes) within 2 weeks after the class. The parenting class itself is attended as usual. The learning content is the same in both groups; only the format differs. Both groups also watch a ward orientation video (about 13 minutes).

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

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Primiparous women who plan to attend a parenting class at Shinshu University Hospital
2. Aged 18 years or older at the time of consent
3. Planning to deliver at the hospital
4. Able to use the game and videos in Japanese
5. Own a smartphone or tablet
6. Planning to visit the hospital in late pregnancy (34 weeks of gestation or later)
7. Written informed consent obtained
Partners of these women may also participate with their own written consent (secondary analyses only).

Key exclusion criteria

1. Instructed by a physician to rest, for example because of threatened preterm labor
2. Under treatment for a severe psychiatric disorder
3. Unable to operate a smartphone or tablet
4. Not planning to visit the hospital in late pregnancy (for example, returning to the family home for delivery)
5. Lacking capacity to consent, or otherwise judged inappropriate by the principal investigator

Target sample size

170

Name of lead principal investigator

1st name	Yukihide
Middle name
Last name	Miyosawa

Organization

Shinshu University School of Medicine

Division name

Department of Pediatrics

Zip code

390-8621

Address

3-1-1 Asahi, Matsumoto, Nagano, Japan

TEL

0263-37-2642

Email

miyosawa@shinshu-u.ac.jp

Name of contact person

1st name	Yukihide
Middle name
Last name	Miyosawa

Organization

Shinshu University School of Medicine

Division name

Department of Pediatrics

Zip code

390-8621

Address

3-1-1 Asahi, Matsumoto, Nagano, Japan

TEL

0263-37-2642

Homepage URL

Email

miyosawa@shinshu-u.ac.jp

Institute

Shinshu University

Institute

Department

Personal name

Organization

Foundation for the Fusion Of Science and Technology (FOST)

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Ethics Committee of Shinshu University School of Medicine

Address

3-1-1 Asahi, Matsumoto, Nagano, Japan

Tel

0263-37-3099

Email

mdrinri@shinshu-u.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

信州大学医学部附属病院（長野県）

Date of disclosure of the study information

2026

Year

11

Month

13

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

There is no plan to share individual participant data.

IPD sharing Plan description

Individual participant data will not be shared. The analysis code will be made available on OSF (Open Science Framework) at the time of publication. A table mapping each test item to the learning materials will be published as a supplement to the paper.

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

10

Month

08

Day

Date of IRB

2026

Year

10

Month

10

Day

Anticipated trial start date

2026

Year

11

Month

19

Day

Last follow-up date

2028

Year

06

Month

30

Day

Date of closure to data entry

2028

Year

06

Month

30

Day

Date trial data considered complete

2028

Year

06

Month

30

Day

Date analysis concluded

2029

Year

03

Month

31

Day

Other related information

The principal investigator is the representative director of Medical Gamification Labo M-terrace, the general incorporated association that developed the serious game used in this trial (no funding is received from the association). The knowledge tests consist only of content covered by both groups, and a table mapping each item to the materials will be published as a supplement. Statistical analysis is performed with group labels masked, and an independent analyst with no relationship to the association re-runs the main analyses. Allocation is by couple, and the primary analysis includes primiparous women only.

Registered date

2026

Year

11

Month

13

Day

Last modified on

2026

Year

11

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072813