- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07606248
Virtual Forest-Based Mindfulness for Perinatal Mental Health
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.
Study Overview
Status
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: HUNG-HUI CHEN, PhD
- Phone Number: 886-2-2394-7109
- Email: hunghuichen@ntu.edu.tw
Study Locations
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Hsinchu, Taiwan, 302058
- National Taiwan University Hospital Hsin-Chu Branch BioMedical Park Hospital
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Contact:
- HUNG-HUI CHEN
- Phone Number: +886-2-23947109
- Email: hunghuichen@ntu.edu.tw
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion CInclusion 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:
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: VR-Based Mindfulness Intervention
Participants will receive immersive virtual reality-based forest mindfulness intervention combined with a 9-week mindfulness program and app-based mindfulness practice during pregnancy.
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Participants will receive immersive virtual reality-based forest mindfulness intervention combined with mindfulness-guided practice during pregnancy.
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Active Comparator: Conventional Mindfulness Intervention
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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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.
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Baseline (20-24 weeks gestation), post-intervention (32 weeks gestation to before delivery), and 1 month, 3 months, and 6 months postpartum
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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
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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.
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Baseline (20-24 weeks gestation), post-intervention (32 weeks gestation to before delivery), and 1 month, 3 months, and 6 months postpartum
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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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.
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Baseline (20-24 weeks gestation), post-intervention (32 weeks gestation to before delivery), and 1 month, 3 months, and 6 months postpartum
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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
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Heart rate variability will be assessed as a physiological indicator of autonomic nervous system activity and stress regulation during the intervention sessions.
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Immediately before and after each of the four in-person intervention sessions conducted between 24 and 32 weeks of gestation during pregnancy
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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
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Systolic and diastolic blood pressure will be measured to assess physiological responses associated with stress and relaxation during the intervention sessions.
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Immediately before and after each of the four in-person intervention sessions conducted between 24 and 32 weeks of gestation during pregnancy
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Fetal Heart Rate
Time Frame: Immediately before and after each of the four in-person intervention sessions conducted between 24 and 32 week
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Fetal heart rate (beats per minute) will be monitored to evaluate maternal-fetal physiological responses during the intervention sessions.
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Immediately before and after each of the four in-person intervention sessions conducted between 24 and 32 week
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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
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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.
Higher scores indicate greater intervention acceptability and satisfaction.
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Immediately after each of the four in-person intervention sessions conducted between 24 and 32 weeks of gestation during pregnancy
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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
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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.
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Immediately before and after each of the four in-person intervention sessions conducted between 24 and 32 weeks of gestation during pregnancy
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Collaborators and Investigators
Investigators
- Principal Investigator: HUNG-HUI CHEN, PhD, National Taiwan University Hostiptal
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 202504140RINC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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