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Not yet recruiting NCT07606248

Virtual Forest-Based Mindfulness for Perinatal Mental Health

No phase Interventional Perinatal Anxiety Perinatal Depression Maternal Mental Health

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Virtual Reality Forest Mindfulness Intervention, Conventional Mindfulness Intervention.
Who it may be relevant to
Registry conditions: Perinatal Anxiety, Perinatal Depression, Maternal Mental Health. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Evaluating the Effects of an Integrated Virtual Forest Environment and Mindfulness-Based Intervention on Mental Health in Perinatal Women

Overview

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

  • Behavioral Virtual Reality Forest Mindfulness Intervention
    Participants will receive immersive virtual reality-based forest mindfulness intervention combined with mindfulness-guided practice during pregnancy.
  • Behavioral Conventional 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.

Primary outcome measures

  • Generalized Anxiety Disorder-7 (GAD-7) Score [Time frame: 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 [Time frame: Baseline (20-24 weeks gestation), post-intervention (32 weeks gestation to before delivery), and 1 month, 3 months, and 6 months postpartum]
Secondary outcome measures (6)
  • Mindful Attention Awareness Scale (MAAS) Score [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Immediately before and after each of the four in-person intervention sessions conducted between 24 and 32 weeks of gestation during pregnancy]

Eligibility criteria

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:

Exclusion criteria

\-

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

Taiwan · 1 center
  • National Taiwan University Hospital Hsin-Chu Branch BioMedical Park Hospital — Hsinchu

Identifiers

NCT: NCT07606248 · 202504140RINC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗