Maternal Mental Health, Perinatal Anxiety, Perinatal Depression
Conditions
Keywords
Virtual reality, Mindfulness, Forest therapy, Perinatal mental health, Pregnancy
Brief summary
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.
Interventions
BEHAVIORALVirtual Reality Forest Mindfulness Intervention
Participants will receive immersive virtual reality-based forest mindfulness intervention combined with mindfulness-guided practice during pregnancy.
BEHAVIORALConventional Mindfulness Intervention
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.
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Pregnant women aged 18 years or older * Gestational age below 25 weeks at recruitment * Able to communicate in Chinese and provide informed consent * Willing to participate in the study and complete follow-up assessments
Exclusion criteria
* Diagnosed epilepsy, photosensitive epilepsy, or other neurological disorders * Severe anxiety, depression, or other psychiatric disorders currently receiving intensive treatment * History of severe adverse reactions to virtual reality devices, including severe dizziness, nausea, or visual discomfort * Inability to participate in mindfulness or VR intervention proceduresriteria:
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Generalized Anxiety Disorder-7 (GAD-7) Score | Baseline (20-24 weeks gestation), post-intervention (32 weeks gestation to before delivery), and 1 month, 3 months, and 6 months postpartum | 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. |
| Edinburgh Postnatal Depression Scale (EPDS) Score | Baseline (20-24 weeks gestation), post-intervention (32 weeks gestation to before delivery), and 1 month, 3 months, and 6 months postpartum | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mindful Attention Awareness Scale (MAAS) Score | Baseline (20-24 weeks gestation), post-intervention (32 weeks gestation to before delivery), and 1 month, 3 months, and 6 months postpartum | 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. |
| Heart Rate Variability | Immediately before and after each of the four in-person intervention sessions conducted between 24 and 35 weeks of gestation during pregnancy | Heart rate variability will be assessed as a physiological indicator of autonomic nervous system activity and stress regulation during the intervention sessions. |
| Systolic and Diastolic Blood Pressure | Immediately before and after each of the four in-person intervention sessions conducted between 24 and 35 weeks of gestation during pregnancy | Systolic and diastolic blood pressure will be measured to assess physiological responses associated with stress and relaxation during the intervention sessions. |
| Fetal Heart Rate | Immediately before and after each of the four in-person intervention sessions conducted between 24 and 35 weeks of gestation during pregnancy | Fetal heart rate (beats per minute) will be monitored to evaluate maternal-fetal physiological responses during the intervention sessions. |
| Intervention Acceptability and Satisfaction | Immediately after each of the four in-person intervention sessions conducted between 24 and 35 weeks of gestation during pregnancy | 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. |
| State Mindfulness Scale (SMS) Score | Immediately before and after each of the four in-person intervention sessions conducted between 24 and 35 weeks of gestation during pregnancy | 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. |
Countries
Taiwan
Contacts
CONTACTHUNG-HUI CHEN, PhD
PRINCIPAL_INVESTIGATORHUNG-HUI CHEN, PhD
National Taiwan University Hospital
Outcome results
None listed