Évaluer l'efficacité d'Une Intervention en réalité Virtuelle Sur le Bien-être Des Femmes Ayant vécu un décès périnatal : un Essai contrôlé randomisé
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Positive and Negative Affect Scale (change)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
TAU+VR
Participants will be invited first to participate to the TAU condition and then to the VR-based intervention.
干预措施: TAU (Other)
VR+TAU
Participants will participate first to a VR-based intervention and then to the TAU condition. The TAU condition is a homogenous standard program proposed by the Centre d'études et de recherché en intervention familiale (CERIF) at Université du Québec en Outaouais (UQO) based on group counseling offered to women and men who experienced a perinatal loss.
干预措施: TAU (Other)
结局指标
主要结局
Positive and Negative Affect Scale (change)
时间窗: Day 1 (pre-assessment), up to 3 weeks from day 1, up to 6 weeks from day 1
Beck Depression Inventory-II (change)
时间窗: 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)
时间窗: Day 1 (pre-assessment), up to 3 weeks from day 1, up to 6 weeks from day 1
Edinburgh Postnatal Depression Scale (change)
时间窗: Day 1 (pre-assessment), up to 3 weeks from day 1, up to 6 weeks from day 1
Perinatal Grief Scale (change)
时间窗: Day 1 (pre-assessment), up to 3 weeks from day 1, up to 6 weeks from day 1
Inventory of Complicated Grief (change)
时间窗: 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)
时间窗: Day 1 (pre-assessment), up to 3 weeks from day 1, up to 6 weeks from day 1
次要结局
- Client Satisfaction Questionnaire(Up to 3 weeks from day 1, up to 6 weeks from day 1)
研究者
Giulia Corno
Postdoctoral fellow
Universite du Quebec en Outaouais
