A Computer Game for Postpartum Mental Health After Emergency Cesarean Birth

NCT ID: NCT07290127

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-13

Study Completion Date

2027-03-31

Brief Summary

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This study aims to explore whether playing the computer game Tetris can reduce PTSD symptoms in women who have undergone emergency caesarean births. Additionally, as a feasibility study, it seeks to provide essential data and insights that will guide the design and implementation of future larger-scale RCTs examining the effects of Tetris in this context.

The specific objectives are to explore:

1. Whether playing Tetris within 24 hours of an emergency C-section help to reduce symptoms of PTSD.
2. Clinical feasibility and acceptability for an intervention (ie. game Tetris) immediately after a cesarean section.
3. Issues arising from the research design, including requitement and sample size.

Participants in the intervention group will play Tetris for at least 10 minutes, but no more than 15 minutes within 24 hours of a C-section.

For outcomes, all participants will complete the questionnaires on the fifth day after the C-section and one month postpartum.

Detailed Description

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Recent research suggests that adverse events related to childbirth and pregnancy, such as emergency caesarean births, can trigger post-traumatic stress disorder (PTSD). Although therapeutic and preventive interventions like trauma-focused cognitive behavioural therapy (CBT) are available, the effectiveness of interventions that do not require specialist expertise remains unclear.

This randomised controlled trial (RCT) aims to determine whether playing the computer game Tetris can reduce the PTSD symptom severity in postpartum women who have undergone emergency caesarean births, a group at higher risk of developing PTSD compared to those who have had spontaneous deliveries. Additionally, this study serves as a feasibility test, establishing a foundation for future larger RCTs examining the effects of Tetris.

Conditions

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Post-traumatic Stress Disorder (PTSD) Postpartum Mental Health

Keywords

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post-traumatic stress disorder PTSD postpartum mental health emergency caesarean birth randomised controlled trial computer game Tetris pilot study feasibility study

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention group

Group Type EXPERIMENTAL

implementation of a brief computer-based intervention "Tetris"

Intervention Type BEHAVIORAL

Within 24 hours of emergency caesarean birth, the participants played Tetris (TetrisⓇ99), a cognitive task, for at least 10 and up to 15 minutes on a Nintendo Switch Lite game console.

Usual care group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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implementation of a brief computer-based intervention "Tetris"

Within 24 hours of emergency caesarean birth, the participants played Tetris (TetrisⓇ99), a cognitive task, for at least 10 and up to 15 minutes on a Nintendo Switch Lite game console.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Women aged 20 years or older
* Women who have undergone an emergency caesarean birth within the previous 24 hours
* Must be able to understand instructions and respond to the questionnaire in Japanese

Exclusion Criteria

* Undergoing treatment for psychiatric disorders such as PTSD, depression, anxiety disorders or schizophrenia.
* Undergoing intensive care after surgery .
* The physician does not approve participation for any physical or mental reasons .
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Kyoto University, Graduate School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Sachiko Asada

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sachiko Asada, Master's degree

Role: PRINCIPAL_INVESTIGATOR

Perinatal epidemiology Department of Human Health Sciences Graduate School of Medicine Kyoto University

Marie Furuta, Ph.D.

Role: STUDY_CHAIR

Perinatal epidemiology Department of Human Health Sciences Graduate School of Medicine Kyoto University

Locations

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Perinatal epidemiology Department of Human Health Sciences Graduate School of Medicine Kyoto University

Kyoto, Sakyo-ku, Japan

Site Status

Countries

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Japan

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Other Identifiers

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C1606

Identifier Type: -

Identifier Source: org_study_id