Évaluer l'efficacité d'Une Intervention en réalité Virtuelle Sur le Bien-être Des Femmes Ayant vécu un décès périnatal : un Essai contrôlé randomisé
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Grief
- Sponsor
- Universite du Quebec en Outaouais
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Positive and Negative Affect Scale (change)
- Last Updated
- 5 years ago
Overview
Brief Summary
The loss of an infant during the perinatal period has been recognized as a complex and potentially traumatic life event and can have a significant impact on women's mental health. However, often times, psychological aftercare is typically not offered, and manualized interventions are rarely used in clinical care practice and have seldom been evaluated. In recent years, a growing number of studies have demonstrated the efficacy of virtual reality (VR) interventions to facilitate the expression and coping with emotions linked to a traumatic event. The objective of the proposed paper is to present the protocol of a randomized control trial aimed to assess a novel VR-based intervention for mothers who experienced a perinatal loss. The investigators hypothesize that the VR-based intervention group will show significantly reduced symptoms related to grief, postnatal depression and general psychopathology after treatment relative to a treatment-as-usual (TAU) group. With the present study the investigators propose to answer to the unquestionable need for interventions addressed to ameliorate the emotional effects in women who experienced perinatal loss, by exploiting also the therapeutic opportunities offered by a new technology as VR.
Investigators
Giulia Corno
Postdoctoral fellow
Universite du Quebec en Outaouais
Eligibility Criteria
Inclusion Criteria
- •Mothers who had recently experienced a perinatal death, including: having lost a child during pregnancy because of miscarriage (i.e., embryo or fetus death prior the 28th week of gestation); termination due to medical indications; stillbirth (i.e., fetus death after 28 completed weeks of gestation); or neonatal death (i.e., infant death within the first 7 days of life).
- •Women who have experienced perinatal death while pregnant within no more than 1 year before the enrollment will be invited to participate to the study.
Exclusion Criteria
- •Significant vision impairments despite wearing corrective glasses or lenses.
- •Presence of a severe and disabling diagnosed mental disorder which requires immediate treatment.
- •Being under psychological treatment.
Outcomes
Primary Outcomes
Positive and Negative Affect Scale (change)
Time Frame: Day 1 (pre-assessment), up to 3 weeks from day 1, up to 6 weeks from day 1
Beck Depression Inventory-II (change)
Time Frame: Day 1 (pre-assessment), up to 3 weeks from day 1, up to 6 weeks from day 1
State and Trait Anxiety Inventory form Y (change)
Time Frame: Day 1 (pre-assessment), up to 3 weeks from day 1, up to 6 weeks from day 1
Edinburgh Postnatal Depression Scale (change)
Time Frame: Day 1 (pre-assessment), up to 3 weeks from day 1, up to 6 weeks from day 1
Perinatal Grief Scale (change)
Time Frame: Day 1 (pre-assessment), up to 3 weeks from day 1, up to 6 weeks from day 1
Inventory of Complicated Grief (change)
Time Frame: Day 1 (pre-assessment), up to 3 weeks from day 1, up to 6 weeks from day 1
Clinical Global Impression rated by the therapist (change)
Time Frame: Day 1 (pre-assessment), up to 3 weeks from day 1, up to 6 weeks from day 1
Secondary Outcomes
- Client Satisfaction Questionnaire(Up to 3 weeks from day 1, up to 6 weeks from day 1)