A Computer Game for Postpartum Mental Health After Emergency Cesarean Birth

NCT07290127 | Enrolling By Invitation

• 1 other identifier: C1606
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Post-traumatic Stress Disorder (PTSD); Postpartum Mental Health

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Impact of Event Scale-Revised (IES-R) scores (intrusive, avoidance and total scores) at one month postpartum

  The participants are asked to report the degree of distress experienced for each item in the past 7 days. The 5 points on the scale are: 0 (not at all), 1 (a little bit), 2 (moderately), 3 (quite a bit), 4 = (extremely).

  At one month postpartum

Secondary Outcomes (6)

• IES-R at 5 days postpartum

  At 5 days postpartum

• Edinburgh Postnatal Depression Scale (EPDS) at 5 days and one month postpartum

  At 5 days and one month postpartum

• Labour Agentry Scale (LAS) at 5 days and one month postpartum

  At 5 days and one month postpartum

• Social Support Questionnaire (SSQ) at 5 days and one month postpartum

  At 5 days and one month postpartum

• Breastfeeding Status

  At 5 days and one month postpartum

Other Outcomes (5)

• The number of women who met the eligibility criteria but declined to participate in the study and their reasons for doing so.

  At one month postpartum

• Follow-up rate

  At one month postpartum

• Questionnaire response rate.

  At one month postpartum.

Study Arms (2)

Intervention group

EXPERIMENTAL

Behavioral: implementation of a brief computer-based intervention "Tetris"

Usual care group

NO INTERVENTION

Interventions

implementation of a brief computer-based intervention "Tetris" 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.

Intervention group

Eligibility Criteria

• Age: 20 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Kyoto University, Graduate School of Medicine: lead

Study Sites (1)

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

Kyoto, Sakyo-ku, 606-8507, Japan

Location

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MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Psychological Well-Being

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Personal Satisfaction; Behavior

Study Officials

• Sachiko Asada, Master's degree

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

  PRINCIPAL INVESTIGATOR

• Marie Furuta, Ph.D.

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: December 18, 2025
• Study Start: December 13, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)