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.
Age range
18 Years
Sex
FEMALE
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The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Perinatal Grief Scale (change)
Timeframe: Day 1 (pre-assessment), up to 3 weeks from day 1, up to 6 weeks from day 1
Inventory of Complicated Grief (change)
Timeframe: Day 1 (pre-assessment), up to 3 weeks from day 1, up to 6 weeks from day 1
Beck Depression Inventory-II (change)
Timeframe: Day 1 (pre-assessment), up to 3 weeks from day 1, up to 6 weeks from day 1
Edinburgh Postnatal Depression Scale (change)
Timeframe: 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)
Timeframe: Day 1 (pre-assessment), up to 3 weeks from day 1, up to 6 weeks from day 1
Positive and Negative Affect Scale (change)
Timeframe: 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)
Timeframe: Day 1 (pre-assessment), up to 3 weeks from day 1, up to 6 weeks from day 1