Virtual Forest-Based Mindfulness for Perinatal Mental Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorNational Taiwan University Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Virtual Reality Forest Mindfulness Intervention
BehavioralParticipants will receive immersive virtual reality-based forest mindfulness intervention combined with mindfulness-guided practice during pregnancy.
Conventional Mindfulness Intervention
BehavioralParticipants 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: VR-Based Mindfulness InterventionExperimental treatment 1 intervention
Group B: Conventional Mindfulness InterventionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (20-24 weeks gestation), post-intervention (32 weeks gestation to before delivery), and 1 month, 3 months, and 6 months postpartum2
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.
Time frame
Baseline (20-24 weeks gestation), post-intervention (32 weeks gestation to before delivery), and 1 month, 3 months, and 6 months postpartumSecondary outcomes
1
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.
Time frame
Baseline (20-24 weeks gestation), post-intervention (32 weeks gestation to before delivery), and 1 month, 3 months, and 6 months postpartum2
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.
Time frame
Immediately before and after each of the four in-person intervention sessions conducted between 24 and 35 weeks of gestation during pregnancy3
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.
Time frame
Immediately before and after each of the four in-person intervention sessions conducted between 24 and 35 weeks of gestation during pregnancy4
Fetal Heart Rate
Fetal heart rate (beats per minute) will be monitored to evaluate maternal-fetal physiological responses during the intervention sessions.
Time frame
Immediately before and after each of the four in-person intervention sessions conducted between 24 and 35 weeks of gestation during pregnancySponsors and contacts
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Source ClinicalTrials.gov