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Virtual Forest-Based Mindfulness for Perinatal Mental Health

16 de agosto de 2026 atualizado por: National Taiwan University Hospital

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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

100

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • Taiwan
      • Hsinchu, Taiwan, 302058
        • Recrutamento
        • National Taiwan University Hospital Hsin-Chu Branch BioMedical Park Hospital
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Descrição

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:

-

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
Comportamental: Virtual Reality Forest Mindfulness Intervention
Participants will receive immersive virtual reality-based forest mindfulness intervention combined with mindfulness-guided practice during pregnancy.
Comparador Ativo: 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.
Comportamental: Conventional Mindfulness Intervention
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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Generalized Anxiety Disorder-7 (GAD-7) Score
Prazo: 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.
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
Prazo: 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.
Baseline (20-24 weeks gestation), post-intervention (32 weeks gestation to before delivery), and 1 month, 3 months, and 6 months postpartum

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Mindful Attention Awareness Scale (MAAS) Score
Prazo: 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.
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
Prazo: Immediately before and after each of the four in-person intervention sessions conducted between 24 and 35 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.
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
Prazo: 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 will be measured to assess physiological responses associated with stress and relaxation during the intervention sessions.
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
Prazo: 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 (beats per minute) will be monitored to evaluate maternal-fetal physiological responses during the intervention sessions.
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
Prazo: Immediately after each of the four in-person intervention sessions conducted between 24 and 35 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.
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
Prazo: Immediately before and after each of the four in-person intervention sessions conducted between 24 and 35 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.
Immediately before and after each of the four in-person intervention sessions conducted between 24 and 35 weeks of gestation during pregnancy

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

National Taiwan University Hospital

Investigadores

  • Investigador principal: HUNG-HUI CHEN, PhD, National Taiwan University Hospital

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

16 de junho de 2026

Conclusão Primária (Estimado)

31 de dezembro de 2027

Conclusão do estudo (Estimado)

31 de dezembro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

12 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

18 de maio de 2026

Primeira postagem (Real)

26 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

18 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

16 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Outros números de identificação do estudo

  • 202504140RINC

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Sim

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