Perinatal AnxietyNCT07606248
Virtual Forest-Based Mindfulness for Perinatal Mental Health
A study testing Virtual Reality Forest Mindfulness Intervention and Conventional Mindfulness Intervention in people with Perinatal Anxiety and Perinatal Depression, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perinatal Anxiety, Perinatal Depression, Maternal Mental Health
- What is being tested?
- Virtual Reality Forest Mindfulness Intervention and Conventional Mindfulness Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Jun 2026to 31 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital Hsin-Chu Branch BioMedical Park Hospital
Hsinchu, 302058
HUNG-HUI CHEN, +886-2-23947109, hunghuichen@ntu.edu.tw
About this study
Official title: Evaluating the Effects of an Integrated Virtual Forest Environment and Mindfulness-Based Intervention on Mental Health in Perinatal Women
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.
- Being tested
- Virtual Reality Forest Mindfulness Intervention, Conventional Mindfulness Intervention
- Keywords
- Virtual reality, Mindfulness, Forest therapy, Perinatal mental health, Pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Forest Mindfulness InterventionBehavioural
Participants will receive immersive virtual reality-based forest mindfulness intervention combined with mindfulness-guided practice during pregnancy.
Conventional Mindfulness InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Virtual Reality Forest Mindfulness Intervention |
| 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. Receives: Behavioral: Conventional Mindfulness Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (20-24 weeks gestation), post-intervention (32 weeks gestation to before delivery), and 1 month, 3 months, and 6 months postpartum
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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
Systolic and diastolic blood pressure will be measured to assess physiological responses associated with stress and relaxation during the intervention sessions.
Measured: 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
Fetal heart rate (beats per minute) will be monitored to evaluate maternal-fetal physiological responses during the intervention sessions.
Measured: Immediately before and after each of the four in-person intervention sessions conducted between 24 and 35 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.
Measured: Immediately after each of the four in-person intervention sessions conducted between 24 and 35 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.
Measured: Immediately before and after each of the four in-person intervention sessions conducted between 24 and 35 weeks of gestation during pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start16 Jun 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perinatal AnxietyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- HUNG-HUI CHEN, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07606248
- Sponsor's protocol ID
- 202504140RINC
- Status last verified
- Aug 2026
- First submitted
- 12 May 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No