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Post-traumatic Stress Disorder (PTSD)NCT07290127

A Computer Game for Postpartum Mental Health After Emergency Cesarean Birth

A study testing implementation of a brief computer-based intervention "Tetris" in people with Post-traumatic Stress Disorder (PTSD) and Postpartum Mental Health, run by Kyoto University, Graduate School of Medicine at 1 site in Japan.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 years and older, women onlyHealthy volunteers can take part
What is being tested?
implementation of a brief computer-based intervention "Tetris"
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteJapan
Study dates
13 Dec 2025to 31 Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 .

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Japan1 site

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

    Kyoto, Sakyo-ku, 606-8507

Other trials in Japan

About this study

Official title: 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:

Read more
  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.

Read the 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.

Being tested
implementation of a brief computer-based intervention "Tetris"
Keywords
post-traumatic stress disorder, PTSD, postpartum, mental health, emergency caesarean birth, randomised controlled trial, computer game, Tetris, pilot study, feasibility study
Medical subject headings
Stress Disorders, Post-Traumatic, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • implementation of a brief computer-based intervention "Tetris"Behavioural

    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.

Study groups in NCT07290127
Study groupRoleWhat they receive
Intervention groupExperimentalNot described
Receives: Behavioral: implementation of a brief computer-based intervention "Tetris"
Usual care groupNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: At one month postpartum

Secondary outcomes (6)

  1. IES-R 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).

    Measured: At 5 days postpartum

  2. Edinburgh Postnatal Depression Scale (EPDS) 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.

    Measured: At 5 days and one month postpartum

  3. Labour Agentry Scale (LAS) 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."

    Measured: At 5 days and one month postpartum

  4. Social Support Questionnaire (SSQ) 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.

    Measured: At 5 days and one month postpartum

  5. Breastfeeding Status

    Type of nutritional method of the newborn .

    Measured: At 5 days and one month postpartum

  6. Number of medical visits and consultations

    Number of visits to medical institutions and telephone consultations after discharge at the 1-month checkup.

    Measured: At one month postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2025
  2. Study start13 Dec 2025
  3. Primary completion31 May 2026 (estimated)
  4. Study completion31 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07290127
Sponsor's protocol ID
C1606
Status last verified
Dec 2025
First submitted
30 Jun 2025
Last updated
18 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Paul IM, Downs DS, Schaefer EW, Beiler JS, Weisman CS. Postpartum anxiety and maternal-infant health outcomes. Pediatrics. 2013 Apr;131(4):e1218-24. doi: 10.1542/peds.2012-2147. Epub 2013 Mar 4.

    PubMed 23460682

  • Turkstra E, Creedy DK, Fenwick J, Buist A, Scuffham PA, Gamble J. Health services utilization of women following a traumatic birth. Arch Womens Ment Health. 2015 Dec;18(6):829-32. doi: 10.1007/s00737-014-0495-7. Epub 2015 Jan 11.

    PubMed 25577338

  • Dias CC, Figueiredo B. Breastfeeding and depression: a systematic review of the literature. J Affect Disord. 2015 Jan 15;171:142-54. doi: 10.1016/j.jad.2014.09.022. Epub 2014 Sep 28.

    PubMed 25305429

  • Cook N, Ayers S, Horsch A. Maternal posttraumatic stress disorder during the perinatal period and child outcomes: A systematic review. J Affect Disord. 2018 Jan 1;225:18-31. doi: 10.1016/j.jad.2017.07.045. Epub 2017 Jul 27.

    PubMed 28777972

  • World Health Organization(2008）: Indicators for assessing infant and young child feeding practices : conclusions of a consensus meeting held 6-8 November 2007 in Washington D.C. ,USA.

  • Furukawa TA, Harai H, Hirai T, Kitamura T, Takahashi K. Social Support Questionnaire among psychiatric patients with various diagnoses and normal controls. Soc Psychiatry Psychiatr Epidemiol. 1999 Apr;34(4):216-22. doi: 10.1007/s001270050136.

    PubMed 10365628

  • Sarason IG, Levine HM, Basham RB, Sarason BR(1983): Assessing Social Support: The Social Support Questionnaire. Journal of Personality and Social Psychology 44(1)127-139.

  • Gurber S, Baumeler L, Grob A, Surbek D, Stadlmayr W. Antenatal depressive symptoms and subjective birth experience in association with postpartum depressive symptoms and acute stress reaction in mothers and fathers: A longitudinal path analysis. Eur J Obstet Gynecol Reprod Biol. 2017 Aug;215:68-74. doi: 10.1016/j.ejogrb.2017.05.021. Epub 2017 May 30.

    PubMed 28601730

  • 毛利多恵子（1994）：産婦の身体拘束が陣痛体験に及ぼす影響．1993年度聖路加看護大学大学院修士論文

  • Hodnett ED, Simmons-Tropea DA. The Labour Agentry Scale: psychometric properties of an instrument measuring control during childbirth. Res Nurs Health. 1987 Oct;10(5):301-10. doi: 10.1002/nur.4770100503.

    PubMed 3671777

  • 岡野 禎, 村田 真, 増地 聡, 他（1996） 日本版エジンバラ産後うつ病自己評価票(EPDS)の信頼性と妥当性. 精神科診断学. 7(4):525-533.

  • Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.

    PubMed 3651732

  • Asukai N, Kato H, Kawamura N, Kim Y, Yamamoto K, Kishimoto J, Miyake Y, Nishizono-Maher A. Reliability and validity of the Japanese-language version of the impact of event scale-revised (IES-R-J): four studies of different traumatic events. J Nerv Ment Dis. 2002 Mar;190(3):175-82. doi: 10.1097/00005053-200203000-00006.

    PubMed 11923652

  • Weiss DS(2004): The Impact of Event Scale-Revised. In: Wilson, J.P., Keane T.M. eds., Assessing psychological trauma and PTSD（Second Edition）. The Guilford Press, New York, 168-189.

  • Ayers S, Rados SN, Balouch S. Narratives of traumatic birth: Quality and changes over time. Psychol Trauma. 2015 May;7(3):234-42. doi: 10.1037/a0039044.

    PubMed 25961868

Questions about this trial

What is this clinical trial studying?

A study testing implementation of a brief computer-based intervention "Tetris" in people with Post-traumatic Stress Disorder (PTSD) and Postpartum Mental Health, run by Kyoto University, Graduate School of Medicine at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Impact of Event Scale-Revised (IES-R) scores (intrusive, avoidance and total scores) at one month postpartum (time frame: At one month postpartum). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07290127, which also lists 42 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.

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