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Perinatal anxiety and depression are common mental health concerns that may negatively affect maternal well-being, infant development, and family functioning. Mindfulness-based interventions have shown beneficial effects on reducing psychological distress during pregnancy; however, maintaining attention and engagement during mindfulness practice may be challenging for some pregnant women.
This randomized controlled trial aims to evaluate the feasibility and effectiveness of an integrated virtual forest environment and mindfulness-based intervention for improving mental health in perinatal women. Pregnant women between 20 and 24 weeks of gestation will be randomly assigned to either an experimental group receiving virtual reality (VR)-based forest mindfulness intervention or a control group receiving conventional mindfulness intervention.
Both groups will participate in a 9-week mindfulness program and receive app-based mindfulness practice. The experimental group will additionally receive immersive VR forest-based mindfulness sessions during prenatal visits. Outcomes including anxiety, depression, mindfulness awareness, physiological indicators, and intervention acceptability will be assessed during pregnancy and postpartum follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VR-Based Mindfulness Intervention | Experimental | Participants will receive immersive virtual reality-based forest mindfulness intervention combined with a 9-week mindfulness program and app-based mindfulness practice during pregnancy. |
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| Conventional Mindfulness Intervention | Active Comparator | Participants will receive conventional mindfulness guidance combined with a 9-week mindfulness program and app-based mindfulness practice during pregnancy without virtual reality exposure. The intervention includes mindfulness-guided audio focusing on breathing awareness, emotional regulation, present-moment attention, and maternal-fetal connection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality Forest Mindfulness Intervention | Behavioral | Participants will receive immersive virtual reality-based forest mindfulness intervention combined with mindfulness-guided practice during pregnancy. |
| Measure | Description | Time Frame |
|---|---|---|
| Generalized Anxiety Disorder-7 (GAD-7) Score | Perinatal anxiety will be assessed using the Generalized Anxiety Disorder-7 (GAD-7), a 7-item self-report questionnaire with scores ranging from 0 to 21. Higher scores indicate greater anxiety severity. | Baseline (20-24 weeks gestation), post-intervention (32 weeks gestation to before delivery), and 1 month, 3 months, and 6 months postpartum |
| Edinburgh Postnatal Depression Scale (EPDS) Score | Perinatal depression will be assessed using the Edinburgh Postnatal Depression Scale (EPDS), a 10-item self-report questionnaire with scores ranging from 0 to 30. Higher scores indicate greater depressive symptom severity. | Baseline (20-24 weeks gestation), post-intervention (32 weeks gestation to before delivery), and 1 month, 3 months, and 6 months postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Mindful Attention Awareness Scale (MAAS) Score | Mindfulness awareness will be assessed using the Mindful Attention Awareness Scale (MAAS), a 15-item self-report questionnaire measuring present-moment awareness and attentional focus in daily life. Each item is rated on a 6-point scale, and total scores are calculated after reverse scoring. Scores range from 15 to 90, with higher scores indicating greater mindfulness awareness. |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| HUNG-HUI CHEN, PhD | Contact | 886-2-2394-7109 | hunghuichen@ntu.edu.tw |
| Name | Affiliation | Role |
|---|---|---|
| HUNG-HUI CHEN, PhD | National Taiwan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital Hsin-Chu Branch BioMedical Park Hospital | Hsinchu | 302058 | Taiwan |
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| Conventional Mindfulness Intervention | Behavioral | Participants will receive conventional mindfulness-guided intervention during pregnancy without virtual reality exposure. The intervention includes mindfulness-guided audio focusing on breathing awareness, emotional regulation, present-moment attention, and maternal-fetal connection. Participants will additionally receive a 9-week mindfulness program and app-based mindfulness practice. |
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| Baseline (20-24 weeks gestation), post-intervention (32 weeks gestation to before delivery), and 1 month, 3 months, and 6 months postpartum |
| Heart Rate Variability | Heart rate variability will be assessed as a physiological indicator of autonomic nervous system activity and stress regulation during the intervention sessions. | Immediately before and after each of the four in-person intervention sessions conducted between 24 and 32 weeks of gestation during pregnancy |
| Systolic and Diastolic Blood Pressure | Systolic and diastolic blood pressure will be measured to assess physiological responses associated with stress and relaxation during the intervention sessions. | Immediately before and after each of the four in-person intervention sessions conducted between 24 and 32 weeks of gestation during pregnancy |
| Fetal Heart Rate | Fetal heart rate (beats per minute) will be monitored to evaluate maternal-fetal physiological responses during the intervention sessions. | Immediately before and after each of the four in-person intervention sessions conducted between 24 and 32 weeks of gestation during pregnancy |
| Intervention Acceptability and Satisfaction | Participant satisfaction and acceptability of the intervention will be evaluated using a study-developed post-session feedback questionnaire assessing satisfaction, perceived enjoyment, intervention experience, and physical discomfort during the intervention sessions. Satisfaction-related items are rated on a 5-point Likert scale. Total scores range from 3 to 15, with higher scores indicating greater intervention acceptability and satisfaction. | Immediately after each of the four in-person intervention sessions conducted between 24 and 32 weeks of gestation during pregnancy |
| State Mindfulness Scale (SMS) Score | Short-term mindfulness awareness will be assessed using the State Mindfulness Scale (SMS), a 21-item self-report questionnaire measuring present-moment awareness of internal experiences, including emotions, thoughts, and bodily sensations. The scale includes psychological mindfulness and bodily mindfulness domains and uses a 5-point Likert scale. Scores range from 21 to 105, with higher scores indicating greater state mindfulness awareness. | Immediately before and after each of the four in-person intervention sessions conducted between 24 and 32 weeks of gestation during pregnancy |