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Enrolling by Invitation

NCT Number: NCT07290127

A Computer Game for Postpartum Mental Health After Emergency Cesarean Birth

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.

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Key information

Conditions

Post-traumatic Stress Disorder (PTSD) Behavior Mental Disorders Personal Satisfaction Postpartum Mental Health Psychological Well-Being Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Kyoto, Sakyo-ku, 606-8507, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

  2. 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.

  3. 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."

  4. 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.

  5. Breastfeeding Status

    Time frame: At 5 days and one month postpartum

    Type of nutritional method of the newborn .

  6. 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.

Other outcomes

  1. 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.

  2. 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%.

  3. Questionnaire response rate.

    Time frame: At one month postpartum.

    Percentage of respondents who answered all the questions. The range is from 0% to 100%.

  4. 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%.

  5. 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.

Sponsors and collaborators

Lead sponsor

Kyoto University, Graduate School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Dec 18, 2025
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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