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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effects of an Integrated Virtual Forest Environment and Mindfulness-Based Intervention on Mental Health in Perinatal Women
- ClinicalTrials.gov ID
- NCT07606248
- Acronym / sponsor ID
- 202504140RINC
- Keywords
- Virtual reality, Mindfulness, Forest therapy, Perinatal mental health, Pregnancy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 16 Jun 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR-Based Mindfulness Intervention | Experimental | Behavioral: Virtual Reality Forest Mindfulness InterventionParticipants will receive immersive virtual reality-based forest mindfulness intervention combined with a 9-week mindfulness program and app-based mindfulness practice during pregnancy. |
| Conventional Mindfulness Intervention | Active comparator | Behavioral: Conventional Mindfulness InterventionParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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:
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality Forest Mindfulness InterventionParticipants will receive immersive virtual reality-based forest mindfulness intervention combined with mindfulness-guided practice during pregnancy. | Behavioural | VR-Based Mindfulness Intervention |
| Conventional Mindfulness InterventionParticipants 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. | Behavioural | Conventional Mindfulness Intervention |
Primary outcome
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.
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.
6 secondary outcomes
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 35 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 35 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 35 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 35 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 35 weeks of gestation during pregnancy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
HUNG-HUI CHEN, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact HUNG-HUI CHEN, PhD (886-2-2394-7109, hunghuichen@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.