A Computer Game for Postpartum Mental Health After Emergency Cesarean Birth

Official title

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

Overview

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

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.

Interventions

• 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.

Primary outcome measures

• Impact of Event Scale-Revised (IES-R) scores (intrusive, avoidance and total scores) at one month postpartum [Time frame: At one month postpartum]

Secondary outcome measures (6)

• IES-R at 5 days postpartum [Time frame: 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]
• Labour Agentry Scale (LAS) at 5 days and one month postpartum [Time frame: 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]
• Breastfeeding Status [Time frame: At 5 days and one month postpartum]
• Number of medical visits and consultations [Time frame: At one month postpartum]

Eligibility criteria

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 .

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

Japan · 1 center

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

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 28601730

Identifiers

NCT: NCT07290127 · C1606

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗