Postpartum Mental Health, Post-traumatic Stress Disorder (PTSD)
Conditions
Keywords
post-traumatic stress disorder, PTSD, postpartum, mental health, emergency caesarean birth, randomised controlled trial, computer game, Tetris, pilot study, feasibility study
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. 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
BEHAVIORALimplementation 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.
Sponsors
Kyoto University, Graduate School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
Yes
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 .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Impact of Event Scale-Revised (IES-R) scores (intrusive, avoidance and total scores) at one month postpartum | 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
| Measure | Time frame | Description |
|---|---|---|
| IES-R at 5 days postpartum | 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). |
| Number of medical visits and consultations | At one month postpartum | Number of visits to medical institutions and telephone consultations after discharge at the 1-month checkup. |
| Edinburgh Postnatal Depression Scale (EPDS) at 5 days and one month postpartum | 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. |
| Labour Agentry Scale (LAS) at 5 days and one month postpartum | 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. |
| Social Support Questionnaire (SSQ) at 5 days and one month postpartum | 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. |
| Breastfeeding Status | At 5 days and one month postpartum | Type of nutritional method of the newborn . |
Other
| Measure | Time frame | Description |
|---|---|---|
| Questionnaire response rate. | At one month postpartum. | Percentage of respondents who answered all the questions. The range is from 0% to 100%. |
| Adherence/compliance rate. | 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%. |
| Reasons for dropping out. | 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. |
| Follow-up rate | 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%. |
| 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 | Feasibility of computer game intervention in the intervention group. The range is from 0 to no upper limit. |
Countries
Japan
Outcome results
None listed