Virtual Forest-Based Mindfulness for Perinatal Mental Health

NCT07606248 | Not Yet Recruiting

• 1 other identifier: 202504140RINC
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Perinatal Anxiety; Perinatal Depression; Maternal Mental Health

Keywords

Virtual reality; Mindfulness; Forest therapy; Perinatal mental health; Pregnancy

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  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

  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

  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

  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

  Immediately after each of the four in-person intervention sessions conducted between 24 and 32 weeks of gestation during pregnancy

Study Arms (2)

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.

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.

Behavioral: Conventional Mindfulness Intervention

Interventions

Virtual Reality Forest Mindfulness Intervention BEHAVIORAL

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

VR-Based Mindfulness Intervention

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.

Conventional Mindfulness Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital Hsin-Chu Branch BioMedical Park Hospital

Hsinchu, 302058, Taiwan

Location

Study Officials

• HUNG-HUI CHEN, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

HUNG-HUI CHEN, PhD

CONTACT

886-2-2394-7109; hunghuichen@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 26, 2026
• Study Start: May 25, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)