A Computer Game for Postpartum Mental Health After Emergency Cesarean Birth

December 14, 2025 updated by: Sachiko Asada, Kyoto University, Graduate School of Medicine

Effects of a Computer Game on Postpartum Mental Health After Emergency Cesarean Birth: a Feasibility Randomized Controlled Trial

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Sakyo-ku
      • Kyoto, Sakyo-ku, Japan, 606-8507
        • Perinatal epidemiology Department of Human Health Sciences Graduate School of Medicine Kyoto University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Behavioral: 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.
No Intervention: Usual care group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of Event Scale-Revised (IES-R) scores (intrusive, avoidance and total scores) at one month postpartum
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
IES-R at 5 days postpartum
Time Frame: At 5 days 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 5 days postpartum
Edinburgh Postnatal Depression Scale (EPDS) at 5 days and one month postpartum
Time Frame: At 5 days and one month postpartum
Each of the 10 questions has four possible responses, with scores ranging from 0 to 3. The scores for all 10 items are then added together to get a total score.
At 5 days and one month postpartum
Labour Agentry Scale (LAS) at 5 days and one month postpartum
Time Frame: At 5 days and one month postpartum
The LAS is a 29-item scale with a single underlying factor relating to mastery and sense of control. It has high internal reliability. The scale includes a 10-item inventory with six positive and four negative descriptions of the perceived degree of control experienced during childbirth. Participants ranked the items on a seven-point scale ranging from (1) "almost all of the time" to (7) "never, or almost never."
At 5 days and one month postpartum
Social Support Questionnaire (SSQ) at 5 days and one month postpartum
Time Frame: At 5 days and one month postpartum
The SSQ is a 6-item questionnaire designed to measure perceptions of and satisfaction with social support. Each item is a question that solicits a two-part answer. The first part asks participants to list all the people that fit the description of the question. The SSQ number score is calculated by adding the total number of responses to all six questions (with a minimum of 0 and no maximum) and dividing by 6 to find the average item score. The second part asks participants to indicate how satisfied they are, in general, with these people. The SSQ satisfaction score is calculated by adding the total number of responses to all six questions (with a minimum of 6 to a maximum of 36) and dividing by six to find the average item score.
At 5 days and one month postpartum
Breastfeeding Status
Time Frame: At 5 days and one month postpartum
Type of nutritional method of the newborn .
At 5 days and one month postpartum
Number of medical visits and consultations
Time Frame: At one month postpartum
Number of visits to medical institutions and telephone consultations after discharge at the 1-month checkup.
At one month postpartum

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of women who met the eligibility criteria but declined to participate in the study and their reasons for doing so.
Time Frame: At one month postpartum
Feasibility of computer game intervention in the intervention group. The range is from 0 to no upper limit.
At one month postpartum
Follow-up rate
Time Frame: At one month postpartum
Percentage of participants who were followed from the beginning of the study until one month postpartum. The range is from 0% to 100%.
At one month postpartum
Questionnaire response rate.
Time Frame: At one month postpartum.
Percentage of respondents who answered all the questions. The range is from 0% to 100%.
At one month postpartum.
Adherence/compliance rate.
Time Frame: Within 24 hours after a cesarean section.
Percentage of intervention group participants who correctly played computer games for the specified amount of time. The range is from 0% to 100%.
Within 24 hours after a cesarean section.
Reasons for dropping out.
Time Frame: Within 24 hours after a cesarean section, at 5 days and one month postpartum.
Describe the reasons why participants dropped out of the study during the research process to evaluate its feasibility.
Within 24 hours after a cesarean section, at 5 days and one month postpartum.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyoto University, Graduate School of Medicine

Investigators

  • Principal Investigator: Sachiko Asada, Master's degree, Perinatal epidemiology Department of Human Health Sciences Graduate School of Medicine Kyoto University
  • Study Chair: Marie Furuta, Ph.D., Perinatal epidemiology Department of Human Health Sciences Graduate School of Medicine Kyoto University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2025

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

June 30, 2025

First Submitted That Met QC Criteria

December 14, 2025

First Posted (Actual)

December 18, 2025

Study Record Updates

Last Update Posted (Actual)

December 18, 2025

Last Update Submitted That Met QC Criteria

December 14, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C1606

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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