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Virtual Forest-Based Mindfulness for Perinatal Mental Health

16 augusti 2026 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

100

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Taiwan
      • Hsinchu, Taiwan, 302058
        • Rekrytering
        • National Taiwan University Hospital Hsin-Chu Branch BioMedical Park Hospital
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Ja

Beskrivning

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:

-

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Beteende: Virtual Reality Forest Mindfulness Intervention
Participants will receive immersive virtual reality-based forest mindfulness intervention combined with mindfulness-guided practice during pregnancy.
Aktiv komparator: 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.
Beteende: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Generalized Anxiety Disorder-7 (GAD-7) Score
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Mindful Attention Awareness Scale (MAAS) Score
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

National Taiwan University Hospital

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

16 juni 2026

Primärt slutförande (Beräknad)

31 december 2027

Avslutad studie (Beräknad)

31 december 2027

Studieregistreringsdatum

Först inskickad

12 maj 2026

Först inskickad som uppfyllde QC-kriterierna

18 maj 2026

Första postat (Faktisk)

26 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

18 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

16 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • 202504140RINC

Plan för individuella deltagardata (IPD)

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NEJ

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produkt tillverkad i och exporterad från U.S.A.

Ja

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