Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07606248

Virtual Forest-Based Mindfulness for Perinatal Mental Health

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Perinatal Anxiety Maternal Mental Health Perinatal Depression

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital Hsin-Chu Branch BioMedical Park Hospital

Hsinchu, 302058, Taiwan

Location contact

HUNG-HUI CHEN

CONTACT

[email protected]

+886-2-23947109

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Virtual Reality Forest Mindfulness Intervention

Behavioral

Participants will receive immersive virtual reality-based forest mindfulness intervention combined with mindfulness-guided practice during pregnancy.

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.

Primary outcomes

  1. 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

    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.

  2. 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

    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 outcomes

  1. 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

    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.

  2. 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

    Heart rate variability will be assessed as a physiological indicator of autonomic nervous system activity and stress regulation during the intervention sessions.

  3. 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

    Systolic and diastolic blood pressure will be measured to assess physiological responses associated with stress and relaxation during the intervention sessions.

  4. 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

    Fetal heart rate (beats per minute) will be monitored to evaluate maternal-fetal physiological responses during the intervention sessions.

  5. 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

    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.

  6. 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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

HUNG-HUI CHEN, PhD

CONTACT

[email protected]

886-2-2394-7109

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 26, 2026
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.